Ignite Creation Date:
2024-07-17 @ 10:43 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06488014
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-28
Brief Title:
Comparison of the Effect of Preoperative and Postoperative Erector Spina Plan Block and Paravertebral Block on Postoperative Pain in Video Assisted Thoracic Surgery VATS
Sponsor:
Ankara University
Organization:
Ankara University
Study Overview
Official Title:
Comparison of the Effect of Preoperative and Postoperative Erector Spina Plan Block and Paravertebral Block on Postoperative Pain in Video Assisted Thoracic Surgery VATS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this prospective controlled randomised clinical trial was to identify the analgesic method that is more effective than two different regional analgesia techniques routinely used for pain control after video-assisted thoracic surgery VATS
The effects of paravertebral block and erector spina plan ESP block on acute pain need for additional analgesics and incidence of chronic pain after video-assisted thoracic surgery VATS will be compared before surgical incision pre-emptive and at the end of surgery
It is aimed to show that ESP block which is a newer method in the literature provides equivalent more effective analgesia with paravertebral block
The effects of paravertebral block and erector spina plan ESP block on acute pain need for additional analgesics and incidence of chronic pain after video-assisted thoracic surgery VATS will be compared before surgical incision pre-emptive and at the end of surgery
It is aimed to show that ESP block which is a newer method in the literature provides equivalent more effective analgesia with paravertebral block
Detailed Description:
Pain after thoracic surgery is common and usually severe due to factors such as surgical incisions damage to the lung tissue and ribs and irritation of the pleura and intercostal nerves by the chest tube Thoracotomy is one of the most painful surgical operations and the incidence of chronic pain has been reported to be approximately 65 in most studies Video-assisted thoracic surgery VATS has become more common in recent years Compared with open thoracotomy VATS reduces postoperative pain morbidity and length of hospital stay which is associated with a smaller extent of tissue trauma However VATS still causes moderate to severe acute postoperative pain and chronic pain with an incidence reported in the range of 25-35
Accelerated rehabilitation is important in thoracic surgery Postoperative outcomes are affected by the patients ability to get out of bed and participate in physical respiratory therapy exercises Inadequate analgesia is also directly related with postoperative pulmonary functions Pain may lead to atelectasis hypoxaemia and pneumonia as a result of ineffective cough and thus inadequate sputum expulsion
Pain management after VATS is important because it may reduce postoperative complications Systemic analgesic methods using intravenous iv drugs such as lidocaine nonsteroidal anti-inflammatory drugs steroids alpha2-adrenergic agonists or N-methyl-D-aspartate NMDA antagonists and thoracic epidural analgesia The multimodal analgesia approach in which regional analgesia methods such as paravertebral block erector spina plan ESP block and serratus anterior plan block are combined is an approach with proven efficacy in recent studies and guidelines Regional analgesia has the potential to reduce postoperative acute pain and chronic pain and to increase early postoperative recovery
Although thoracic epidural anaesthesia TEA is considered the gold standard for the treatment of postoperative pain in thoracic surgery the presence of possible side effects such as dura perforation nerve damage epidural bleeding risk of hypotension and urinary retention has shown that VATS may require less invasive analgesia Thoracic paravertebral block TPVB provides unilateral thoracic analgesia comparable to TEA In addition it is not only less invasive than TEA but also can maintain haemodynamic stability and carries a lower risk of complications According to the Enhanced Recovery After Surgery ERAS guidelines and the Procedure-specific postoperative pain Management PROSPECT group TPVB is recommended as the primary method of regional analgesia for thoracic surgery
Paravertebral local anaesthetic may spread to multiple levels into the epidural and intercostal spaces blocking the spinal nerve and sympathetics resulting in segmental block and ipsilateral sympathectomy Major risks or complications of PVB include pneumothorax hypotension due to bilateral PVBs dural puncture and possible risks associated with epidural injections including epidural abscess epidural haematoma In recent years there has been increasing interest in fascial plane blocks which involve spreading large amounts of local anaesthetics into the fascial planes through which nerves pass or communicate with other areas containing the nerves of interest The erector spinae plane block is the most widely investigated fascial plane block that is most suitable for thoracic surgery It is technically easier to perform and theoretically has lower risks of serious adverse events associated with TEA and PVB including epidural haematoma or abscess or pneumothorax and is less likely to cause sympathectomy or hypotension ESPB targets the facial plane between the erector spinae muscles and the posterior border of the transverse processes blocking the dorsal branches of the spinal nerves and potentially spreading anteriorly into the adjacent paravertebral and epidural spaces blocking the ventral rami and sympathetic chain
In VATS patients ESPB resulted in lower PACU pain scores in the first six hours lower opioid consumption and shorter PACU length of stay compared with placebo control There are mixed data on the efficacy of ESPB compared with PVB Although two equivalence studies failed to demonstrate any clinically significant difference in postoperative pain scores between PVB and ESPB for VATS two other clinical trials have shown that PVB provides better analgesia in VATS patients
Preemptive analgesia is a type of antinociceptive treatment Its emergence is based on the clinical observations of Crile and experimental studies of Woolf They demonstrated that various antinociceptive techniques applied pre-injury were more effective in reducing central nervous system sensitisation than those applied post-injury The putative mechanisms of chronic postoperative pain can be explained as sensitisation of peripheral sensory neurons neuroplasticity in the central nervous system and neuropathic signalling in the neuro-immune axis The aim of preemptive analgesia is to prevent central nervous system sensitisation caused by the incision and the inflammatory process caused by the incision with pain relief interventions starting before surgical incision
In our clinic the investigators routinely apply both paravertebral block and erector spina block before andor after the incision as part of a multimodal analgesia approach Different anaesthetists may have different preferences in the choice of field block In this study the investigators planned to investigate the effects of paravertabral block and erector spina plan block before and after VATS on postoperative pain scores and prevention of chronicity of pain
RESEARCH DESİGN
Primary Endpoint Lower pain scores with erector spina plan block in acute post-thoracoscopy pain control
Secondary Endpoint Less chronic pain with erector spina plan block
METHOD
VATS Video Assisted Thoracic Surgery patients who give consent to the study in the preoperative evaluation and meet the inclusion criteria will be included in the study
Patients will be grouped according to the analgesia method applied Demographic data of patients who meet the inclusion criteria will be recorded Routine ASA monitoring ECG fingertip saturation noninvasive blood pressure neuromuscular junction monitoring TOF depth of anaesthesia monitoring BIS Anaesthesia induction 1 mcgkg fentanyl 1 mgkg lidocaine 2-25 mgkg propofol 1 mgkg rocuronium Intubation It will be performed when BIS 40-60 TOF rate is 0 Rightleft lateral position will be given according to the side of the patients operation
Before and after the surgical incision the pre-emptive and postoperative block ESPB Paravertebral block will be recorded from the side where the patient will be operated at the T5 level accompanied by routine USG
Drug content to be administered total 25 cc volume 135 ml 05 bupivacaine 5 ml 2 lidocaine 15 ml morphine morphine reconstituted with 09 NaCl to 1mgml 5 ml 09 NaCl This dose application is the routine doses applied in such surgeries in our clinic Maintenance of anaesthesia Desflurane MAC titration with BIS in the range 40-60
Within the multimodal analgesia protocol
1 mgkgh lidocaine infusion Dexketoprofen 50 mg iv 40 mgkg Magnesium infusion 15 min in 100 cc 09 NaCl Paracetamol 1 gram iv infusion at the end of surgery Anaesthetic drugs will be discontinued 4mgkg sugammadex will be administered to reverse neuromuscular blockade
Extubation will be performed after BIS 90 and TOF ratio 90 Postoperative intravenous PCA patient controlled analgesia will be prepared PCA content infusion none -- bolus 025 mcgkgmin fentanyl -- lock time 15 min Acute and chronic pain of the patients will be monitored in the postoperative period It will be evaluated with VAS Visual analogue scale - ANNEX-1
Pain monitoring will be performed in the postoperative waking unit 20min and postoperative 2nd - 6th - 12th - 24th - 48th - 72nd hours
The degree of pain at rest with cough and movement to be evaluated with VAS the need for additional analgesics the number of PCA bolus trials and the number given will be recorded Postoperative oxygen requirement will be recorded
Postoperative analgesia IV Fentanyl PCA Bolus 025 mcgkg locked time 15 minutes If VAS 4 and PCA bolus is insufficient parol 1 g iv or dexketoprofen 50 mg iv infusion is given
For the evaluation of chronic pain a phone call will be made at the 3rd month and 6th month postoperatively and pain questioning will be performed
Presenceabsence of pain VAS score if present whether there is a need for chronic analgesics whether there is a need for additional intervention what was done if additional analgesic intervention was performed Local anaesthetic drug doses in regional anaesthesia source Kirk P H I I L I I P P Berde C B 2020 Local anaesthetics Millers Anaesthesia 9th ed Philadelphia Elsevier Inc 878-9
RANDOMİSATİON The randomisation of the volunteers participating in the study will be ensured by randomising the order in which the patients were historically admitted to the operation and the method to be applied during the writing of the protocol
After the study started the groups were determined as follows by accepting the order in which the patients were historically admitted to the operation
GROUP E ESP group 1346810 14 15 17 18 22 23 24 27 28 29 32 33 36 38 44454647 53 54 55 56 57 58 61 64 65 68 70 72 73 76 77
GROUP P Paravertebral Group 2 5 7 9 1112 13 16 19 20 21 25263031 34 35 37 39 40 41 42 43 48 49 50 51 52 59 60 62 63 66 67 69 71 74 75 78
STATISTICAL ANALYSIS
SAMPLE DIAMETER The sample size of the study was calculated in GPower 3192 programme In the sample article the mean PCA demand dose was 3664269 in the ESPB group and 18821367 in the TPVB group When these data were taken into consideration the effect size was calculated as 083 α005 and 95 power and the sample size required for each group was calculated as 39 total 78
STATISTICAL ANALYSIS Data will be analysed in IBM SPSS Statistics version 23 package programme Descriptive statistics will be shown as mean standard deviation for variables with normal distribution median min - max for variables with non-normal distribution number of cases and for nominal variables
The significance of the difference between the groups in terms of means will be investigated by t test and the significance of the difference in terms of median values will be investigated by mann whitney test Nominal variables will be evaluated by Pearson Chi-Square or Fisher exact test
In continuous variables the change according to time before and after treatment will be investigated by paired t test if the distribution is normal and by Wilcoxon test if the distribution is not normal When there are more than two follow-up times the change will be investigated by repeated measures analysis of variance if the distribution is normal and Friedman test if the distribution is not normal The change according to time group and grouptime interaction will be investigated by two-way analysis of variance in repeated measures if the distribution is normal and by F1_LD_F1 nonparametric method if the distribution is not normal
The results will be considered statistically significant for p005
At the end of the study all eligible volunteers who completed the study will be included in the statistical analysis
Accelerated rehabilitation is important in thoracic surgery Postoperative outcomes are affected by the patients ability to get out of bed and participate in physical respiratory therapy exercises Inadequate analgesia is also directly related with postoperative pulmonary functions Pain may lead to atelectasis hypoxaemia and pneumonia as a result of ineffective cough and thus inadequate sputum expulsion
Pain management after VATS is important because it may reduce postoperative complications Systemic analgesic methods using intravenous iv drugs such as lidocaine nonsteroidal anti-inflammatory drugs steroids alpha2-adrenergic agonists or N-methyl-D-aspartate NMDA antagonists and thoracic epidural analgesia The multimodal analgesia approach in which regional analgesia methods such as paravertebral block erector spina plan ESP block and serratus anterior plan block are combined is an approach with proven efficacy in recent studies and guidelines Regional analgesia has the potential to reduce postoperative acute pain and chronic pain and to increase early postoperative recovery
Although thoracic epidural anaesthesia TEA is considered the gold standard for the treatment of postoperative pain in thoracic surgery the presence of possible side effects such as dura perforation nerve damage epidural bleeding risk of hypotension and urinary retention has shown that VATS may require less invasive analgesia Thoracic paravertebral block TPVB provides unilateral thoracic analgesia comparable to TEA In addition it is not only less invasive than TEA but also can maintain haemodynamic stability and carries a lower risk of complications According to the Enhanced Recovery After Surgery ERAS guidelines and the Procedure-specific postoperative pain Management PROSPECT group TPVB is recommended as the primary method of regional analgesia for thoracic surgery
Paravertebral local anaesthetic may spread to multiple levels into the epidural and intercostal spaces blocking the spinal nerve and sympathetics resulting in segmental block and ipsilateral sympathectomy Major risks or complications of PVB include pneumothorax hypotension due to bilateral PVBs dural puncture and possible risks associated with epidural injections including epidural abscess epidural haematoma In recent years there has been increasing interest in fascial plane blocks which involve spreading large amounts of local anaesthetics into the fascial planes through which nerves pass or communicate with other areas containing the nerves of interest The erector spinae plane block is the most widely investigated fascial plane block that is most suitable for thoracic surgery It is technically easier to perform and theoretically has lower risks of serious adverse events associated with TEA and PVB including epidural haematoma or abscess or pneumothorax and is less likely to cause sympathectomy or hypotension ESPB targets the facial plane between the erector spinae muscles and the posterior border of the transverse processes blocking the dorsal branches of the spinal nerves and potentially spreading anteriorly into the adjacent paravertebral and epidural spaces blocking the ventral rami and sympathetic chain
In VATS patients ESPB resulted in lower PACU pain scores in the first six hours lower opioid consumption and shorter PACU length of stay compared with placebo control There are mixed data on the efficacy of ESPB compared with PVB Although two equivalence studies failed to demonstrate any clinically significant difference in postoperative pain scores between PVB and ESPB for VATS two other clinical trials have shown that PVB provides better analgesia in VATS patients
Preemptive analgesia is a type of antinociceptive treatment Its emergence is based on the clinical observations of Crile and experimental studies of Woolf They demonstrated that various antinociceptive techniques applied pre-injury were more effective in reducing central nervous system sensitisation than those applied post-injury The putative mechanisms of chronic postoperative pain can be explained as sensitisation of peripheral sensory neurons neuroplasticity in the central nervous system and neuropathic signalling in the neuro-immune axis The aim of preemptive analgesia is to prevent central nervous system sensitisation caused by the incision and the inflammatory process caused by the incision with pain relief interventions starting before surgical incision
In our clinic the investigators routinely apply both paravertebral block and erector spina block before andor after the incision as part of a multimodal analgesia approach Different anaesthetists may have different preferences in the choice of field block In this study the investigators planned to investigate the effects of paravertabral block and erector spina plan block before and after VATS on postoperative pain scores and prevention of chronicity of pain
RESEARCH DESİGN
Primary Endpoint Lower pain scores with erector spina plan block in acute post-thoracoscopy pain control
Secondary Endpoint Less chronic pain with erector spina plan block
METHOD
VATS Video Assisted Thoracic Surgery patients who give consent to the study in the preoperative evaluation and meet the inclusion criteria will be included in the study
Patients will be grouped according to the analgesia method applied Demographic data of patients who meet the inclusion criteria will be recorded Routine ASA monitoring ECG fingertip saturation noninvasive blood pressure neuromuscular junction monitoring TOF depth of anaesthesia monitoring BIS Anaesthesia induction 1 mcgkg fentanyl 1 mgkg lidocaine 2-25 mgkg propofol 1 mgkg rocuronium Intubation It will be performed when BIS 40-60 TOF rate is 0 Rightleft lateral position will be given according to the side of the patients operation
Before and after the surgical incision the pre-emptive and postoperative block ESPB Paravertebral block will be recorded from the side where the patient will be operated at the T5 level accompanied by routine USG
Drug content to be administered total 25 cc volume 135 ml 05 bupivacaine 5 ml 2 lidocaine 15 ml morphine morphine reconstituted with 09 NaCl to 1mgml 5 ml 09 NaCl This dose application is the routine doses applied in such surgeries in our clinic Maintenance of anaesthesia Desflurane MAC titration with BIS in the range 40-60
Within the multimodal analgesia protocol
1 mgkgh lidocaine infusion Dexketoprofen 50 mg iv 40 mgkg Magnesium infusion 15 min in 100 cc 09 NaCl Paracetamol 1 gram iv infusion at the end of surgery Anaesthetic drugs will be discontinued 4mgkg sugammadex will be administered to reverse neuromuscular blockade
Extubation will be performed after BIS 90 and TOF ratio 90 Postoperative intravenous PCA patient controlled analgesia will be prepared PCA content infusion none -- bolus 025 mcgkgmin fentanyl -- lock time 15 min Acute and chronic pain of the patients will be monitored in the postoperative period It will be evaluated with VAS Visual analogue scale - ANNEX-1
Pain monitoring will be performed in the postoperative waking unit 20min and postoperative 2nd - 6th - 12th - 24th - 48th - 72nd hours
The degree of pain at rest with cough and movement to be evaluated with VAS the need for additional analgesics the number of PCA bolus trials and the number given will be recorded Postoperative oxygen requirement will be recorded
Postoperative analgesia IV Fentanyl PCA Bolus 025 mcgkg locked time 15 minutes If VAS 4 and PCA bolus is insufficient parol 1 g iv or dexketoprofen 50 mg iv infusion is given
For the evaluation of chronic pain a phone call will be made at the 3rd month and 6th month postoperatively and pain questioning will be performed
Presenceabsence of pain VAS score if present whether there is a need for chronic analgesics whether there is a need for additional intervention what was done if additional analgesic intervention was performed Local anaesthetic drug doses in regional anaesthesia source Kirk P H I I L I I P P Berde C B 2020 Local anaesthetics Millers Anaesthesia 9th ed Philadelphia Elsevier Inc 878-9
RANDOMİSATİON The randomisation of the volunteers participating in the study will be ensured by randomising the order in which the patients were historically admitted to the operation and the method to be applied during the writing of the protocol
After the study started the groups were determined as follows by accepting the order in which the patients were historically admitted to the operation
GROUP E ESP group 1346810 14 15 17 18 22 23 24 27 28 29 32 33 36 38 44454647 53 54 55 56 57 58 61 64 65 68 70 72 73 76 77
GROUP P Paravertebral Group 2 5 7 9 1112 13 16 19 20 21 25263031 34 35 37 39 40 41 42 43 48 49 50 51 52 59 60 62 63 66 67 69 71 74 75 78
STATISTICAL ANALYSIS
SAMPLE DIAMETER The sample size of the study was calculated in GPower 3192 programme In the sample article the mean PCA demand dose was 3664269 in the ESPB group and 18821367 in the TPVB group When these data were taken into consideration the effect size was calculated as 083 α005 and 95 power and the sample size required for each group was calculated as 39 total 78
STATISTICAL ANALYSIS Data will be analysed in IBM SPSS Statistics version 23 package programme Descriptive statistics will be shown as mean standard deviation for variables with normal distribution median min - max for variables with non-normal distribution number of cases and for nominal variables
The significance of the difference between the groups in terms of means will be investigated by t test and the significance of the difference in terms of median values will be investigated by mann whitney test Nominal variables will be evaluated by Pearson Chi-Square or Fisher exact test
In continuous variables the change according to time before and after treatment will be investigated by paired t test if the distribution is normal and by Wilcoxon test if the distribution is not normal When there are more than two follow-up times the change will be investigated by repeated measures analysis of variance if the distribution is normal and Friedman test if the distribution is not normal The change according to time group and grouptime interaction will be investigated by two-way analysis of variance in repeated measures if the distribution is normal and by F1_LD_F1 nonparametric method if the distribution is not normal
The results will be considered statistically significant for p005
At the end of the study all eligible volunteers who completed the study will be included in the statistical analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None