Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06377605
Status:
RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-04-17
Brief Title:
The Efficacy of Thoracic Erector Spinae Plane Block For Perioperative Analgesia in Laparoscopic Bariatric Surgery for Super Obese Patients
Sponsor:
Amany Ahmed Eissa
Organization:
Kasr El Aini Hospital
Study Overview
Official Title:
The Efficacy of Thoracic Erector Spinae Plane Block For Perioperative Analgesia in Laparoscopic Bariatric Surgery for Super Obese Patients Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-10
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 epidemic of overweight and obesity presents a major challenge to chronic disease prevention and health across the life course around the world 1 Bariatric surgery has proved to be an efficient intervention in the management of obesity As a result the number of post-bariatric surgery patients in the population is growing 2
Postoperative analgesia presents various challenges in vulnerable patient groups suffering from obesity With the high potential risk of respiratory depression and postoperative pulmonary complications associated with opioid use such as atelectasis and pneumonia the availability of other pain management modalities is essential 14
Ultrasound-guided erector spinae plane block ESPB is a regional anesthesia technique where local anesthetic agent is injected deep to the erector spinae muscle to fascial plane and allowed to diffuse caudally and cranially It is supposed to provide both visceral and somatic abdominal analgesia 3
ESPB is effective easy to perform and can be performed in a short time 4 It has been shown efficacy in different conditions such as thoracic surgery trauma cardiac surgery breast surgery and abdominal surgery 5 However the main concern with the ESPB block is feasibility together with the potency of the block in challenging populations such as patients suffering from obesity
Peripheral nerve blocks in the obese may pose challenges like difficulties in proper patient positioning and landmark identification However Ultrasound guidance may help overcome many difficulties in regional techniques But as expected targets are more deeply situated in obese patients and the ultrasound beams are attenuated as they travel a greater distance through tissue layers Additionally when crossing a tissue boundary a portion is reflected back to the transducer creating artifacts like speckling and clutter which are particular problems in the obese patient 15 Few studies examined the use of ESPB in bariatric surgery 367 all indicating potential benefits of the technique in terms of opioid sparing and pain control To date the efficacy of ESPB has not been examined in superobese patient
So we aim to compare the perioperative analgesic effect of bilateral ultrasound-guided ESPB with controls Local bupivacaine infiltration to the trocar sites in super obese patients undergoing bariatric surgery We hypothesis that ESBP provides good applicable modality of perioperative analgesia for superobese patients undergoing bariatric surgeries
Postoperative analgesia presents various challenges in vulnerable patient groups suffering from obesity With the high potential risk of respiratory depression and postoperative pulmonary complications associated with opioid use such as atelectasis and pneumonia the availability of other pain management modalities is essential 14
Ultrasound-guided erector spinae plane block ESPB is a regional anesthesia technique where local anesthetic agent is injected deep to the erector spinae muscle to fascial plane and allowed to diffuse caudally and cranially It is supposed to provide both visceral and somatic abdominal analgesia 3
ESPB is effective easy to perform and can be performed in a short time 4 It has been shown efficacy in different conditions such as thoracic surgery trauma cardiac surgery breast surgery and abdominal surgery 5 However the main concern with the ESPB block is feasibility together with the potency of the block in challenging populations such as patients suffering from obesity
Peripheral nerve blocks in the obese may pose challenges like difficulties in proper patient positioning and landmark identification However Ultrasound guidance may help overcome many difficulties in regional techniques But as expected targets are more deeply situated in obese patients and the ultrasound beams are attenuated as they travel a greater distance through tissue layers Additionally when crossing a tissue boundary a portion is reflected back to the transducer creating artifacts like speckling and clutter which are particular problems in the obese patient 15 Few studies examined the use of ESPB in bariatric surgery 367 all indicating potential benefits of the technique in terms of opioid sparing and pain control To date the efficacy of ESPB has not been examined in superobese patient
So we aim to compare the perioperative analgesic effect of bilateral ultrasound-guided ESPB with controls Local bupivacaine infiltration to the trocar sites in super obese patients undergoing bariatric surgery We hypothesis that ESBP provides good applicable modality of perioperative analgesia for superobese patients undergoing bariatric surgeries
Detailed Description:
Following approval from Ethics and Research Committee of Anaesthesia Department Faculty of Medicine Cairo University 60 patients fulfilling inclusion criteria will be included in this randomized prospective comparative trial
Apreoperative
History will be taken from all patients Age and then American Society Anaesthesiologists ASA score will be recorded
Preoperatively patients laboratory investigations as complete blood picture coagulation profile liver and renal functions will be recorded General examination will be carried out with examination of the back to exclude infection at the injection site and anatomical deformities
Baseline vital signs will be recorded including non-invasive measurement of systolic mean diastolic arterial pressures and HR and oxygen saturation After inserting an intravenous IV access the patient will be pre-medicated with metoclopramide in a dose 01-02 mgkg
Patient will be randomly assigned into 1 of 2 groups according to the intervention used whether
Group A 30 patients Erector Spinae block
Group B 30 patients local anaesthetic infiltration Upon arrival to OR perioperative monitoring including continuous Electro Cardio Gram GE-Datex Ohmeda 5 leads ECG cable pulse oximetry GE- Datex Ohmeda finger SpO2 sensor non-invasive arterial blood pressure GE-Datex Ohmeda NIBP cuff will be applied
In group A block will be performed by the primary investigator the the block will be performed preoperatively with 1mg midazolam administration intravenous and 5 cm lidocaine 1 infiltration at each side prior to the block
the patient will be placed in the lateral or sitting position Then the Erector Spinae block will be given by a high-frequency linear ultrasound transducer of Siemens acuson x300 3-5MHz ultrasound It will be sagittally placed against the target vertebral level T7 transverse process 8 in the lateral or sitting position and moved in approximately 3-cm lateral to the spinous process The Erector Spinae muscle and transverse process will be then identified and a blunted tip 20-gauge short bevel needle Pajunk Sonoplex Geisingen Germany will be advanced using the in-plane approach in cephalad-to-caudal direction through the interfascial plane between the Erector Spinae and the underlying transverse process under strict aseptic precautions until the tip is deep to erector spinae muscle as evidenced by visible hydro-dissection below the muscle plane and on injection of 5 ml normal saline to confirm the correct needle tip position The block will be performed bilaterally by injecting 60 mL of 025 bupivacaine 30 mL into each side 16 into the fascial plane between the deep surface of the Erector Spinae muscle and the transverse processes of the lumbar vertebrae laterally at the most lateral part of the transverse process and since it is a fascial plane block the greater the volume of the local anaesthetic injected the distribution will be better
Bintraoperative
Then general anaesthesia will be induced in both groups 1-2 μgkg fentanyl based on lean body weight 3 with maximum dose of 200 μg and 2 mgkg propofol will be given based on total body weight 3 Tracheal intubation will be facilitated with 05 mgkg atracurium based on ideal body weight 10
In Group B Control group the participant will receive 5 ml bupivacaine infiltration to each trocar site total of 25 ml 05 at the beginning of the operation
For both groups Anaesthesia will be maintained using isoflurane in oxygen and air Additional doses of 01 mgkg atracurium will be administrated every 30 minutes The surgical intervention will be then allowed 20 minutes after finishing the block procedure in group A
Pressure control volume guarantee ventilation will be adjusted to maintain normocapnia Anesthesia will be maintained by using 1-15 isoflurane in a mixture of oxygen and air 5050 and atracurium top ups at a dose of 01mgkg every 30 minutes
All participants will be given 1 gram of intravenous paracetamol with maximum dose of 4 gm every 24 hour Failed block increase in HR and mean arterial blood pressure MABP20 from base line with skin incision will be treated by 1ug kg of fentanyl as top-up doses and increasing isoflurane concentration in case of inadequate response to fentanyl
20 minute before the end of the surgery ketorolac 05mgkg diluted in 100 ml of saline will be given intravenously After skin closure inhalational anesthesia will be discontinued and reversal of muscle relaxation with atropine 002 mgKg and neostigmine 005 mgKg will be administered intravenous after return of patients spontaneous breathing Patients will then be transferred to post anesthesia care unit PACU for 60 min to complete recovery and monitoring
At any time hypotension defined as a decrease in mean arterial pressure MAP 20 from baseline value or systolic arterial pressure SAP 100 mmHg will be treated with 5 mg IV bolus ephedrine and repeated every 3 minutes until the hypotension resolved Bradycardia defined as a HR 40 beats per minute will be treated with atropine 05 mg IV11
Cpostoperative
In the PACU VAS will be assessed 15 min after extubation and when the score exceeds 310 rescue analgesia in the form of nalbuphine 01 mgKg with maximum dose of 30 mg every 24 hours will be given Another dose of nalbuphine 01 mgkg can be given in the PACU if the score still more than 3 after 30 min of the 1st dose
After discharging from the PACU the analgesic plan will be intravenous paracetamol one gram every 8 hours ketorolac 05mgkg 6 hours if VAS score 3 and nalbuphine as second rescue analgesia 01 mgkg 8 hours as long as the pain score is more than 310 reassessment to be done after 30 mins of administration of first rescue analgesia
3 Measurement tools
Patients characteristics including patients age in years weight in kilogramsBMI gender type of surgery
All hemodynamic parameters as blood pressure using non-invasive measurement heart rate oxygen saturation will be recorded at baseline 5 mins after intubation every 10 min till the end of the surgery immediately after extubation 5 min after extubation and every 10 mins in PACU for 30 min till the discharge of the patient
Failed blocks will be documented patient requirement of consecutive rescue analgesia
the patients will be evaluated regarding the time to first demand to rescue analgesia postoperatively
The pain will be assessed by the VAS score It will be performed in the immediate post-operative period every 30 min for the first hour 2 h 4 h 8h 12h and 24 h Breakthrough pain will be defined as VAS 3 at rest
Pain will be classified as mild VAS 1-3 moderate VAS 4-6 and severe VAS 7-10
Postoperative regular analgesia will be prescribed for all patients in the form of paracetamol every 8 hours Rescue analgesia will be administered if VAS is 3 at any time with IV ketorolac 05 mgkg diluted in 100 ml normal saline and administered slowly every 6 hours
Reassessment of VAS score will be done and if VAS is still 3 the second rescue analgesic planned will be IV nalbuphine 01 mgkg every 8 hours
The time interval between the first and the second rescue analgesia will be 30 minutes if VAS score remains persistently 3
Time at which the patient start to ambulate in both groups will be recorded 12
PONV in first 24hr will be monitored and documented if occurred
complications such as hematoma at the site of injection and local anesthetic toxicity will be documented
Quality of recovery questionnaireQoR15
VI Study outcomes
1 Primary outcome Total opioid consumption morphine equivalent dose in both groups in 24hr postoperative including Intraoperative fentanyl and postoperative nalluphine
2 Secondary outcomes
1 VAS score during first 24 hour postoperative
2 Failure rate in performing the block
3 Patient demographic data age sex ASA classification BMI and type of surgery
4 Postoperative nausea and vomiting in first 24 hours
5 Time at which the patient start to ambulate in both groups
6 Haemodynamic parameters heartrateBlood pressure recorded intraoperative immediately postoperatively and in PAICU
7 Incidence of complications related to the block as infection or hematoma at the site of injection local anaesthetic toxicity or pneumothorax
8 Time for first rescue analgesia in both groups
9 Quality of recovery questionnaire QoR15 after 24hr from the end of the surgery
Apreoperative
History will be taken from all patients Age and then American Society Anaesthesiologists ASA score will be recorded
Preoperatively patients laboratory investigations as complete blood picture coagulation profile liver and renal functions will be recorded General examination will be carried out with examination of the back to exclude infection at the injection site and anatomical deformities
Baseline vital signs will be recorded including non-invasive measurement of systolic mean diastolic arterial pressures and HR and oxygen saturation After inserting an intravenous IV access the patient will be pre-medicated with metoclopramide in a dose 01-02 mgkg
Patient will be randomly assigned into 1 of 2 groups according to the intervention used whether
Group A 30 patients Erector Spinae block
Group B 30 patients local anaesthetic infiltration Upon arrival to OR perioperative monitoring including continuous Electro Cardio Gram GE-Datex Ohmeda 5 leads ECG cable pulse oximetry GE- Datex Ohmeda finger SpO2 sensor non-invasive arterial blood pressure GE-Datex Ohmeda NIBP cuff will be applied
In group A block will be performed by the primary investigator the the block will be performed preoperatively with 1mg midazolam administration intravenous and 5 cm lidocaine 1 infiltration at each side prior to the block
the patient will be placed in the lateral or sitting position Then the Erector Spinae block will be given by a high-frequency linear ultrasound transducer of Siemens acuson x300 3-5MHz ultrasound It will be sagittally placed against the target vertebral level T7 transverse process 8 in the lateral or sitting position and moved in approximately 3-cm lateral to the spinous process The Erector Spinae muscle and transverse process will be then identified and a blunted tip 20-gauge short bevel needle Pajunk Sonoplex Geisingen Germany will be advanced using the in-plane approach in cephalad-to-caudal direction through the interfascial plane between the Erector Spinae and the underlying transverse process under strict aseptic precautions until the tip is deep to erector spinae muscle as evidenced by visible hydro-dissection below the muscle plane and on injection of 5 ml normal saline to confirm the correct needle tip position The block will be performed bilaterally by injecting 60 mL of 025 bupivacaine 30 mL into each side 16 into the fascial plane between the deep surface of the Erector Spinae muscle and the transverse processes of the lumbar vertebrae laterally at the most lateral part of the transverse process and since it is a fascial plane block the greater the volume of the local anaesthetic injected the distribution will be better
Bintraoperative
Then general anaesthesia will be induced in both groups 1-2 μgkg fentanyl based on lean body weight 3 with maximum dose of 200 μg and 2 mgkg propofol will be given based on total body weight 3 Tracheal intubation will be facilitated with 05 mgkg atracurium based on ideal body weight 10
In Group B Control group the participant will receive 5 ml bupivacaine infiltration to each trocar site total of 25 ml 05 at the beginning of the operation
For both groups Anaesthesia will be maintained using isoflurane in oxygen and air Additional doses of 01 mgkg atracurium will be administrated every 30 minutes The surgical intervention will be then allowed 20 minutes after finishing the block procedure in group A
Pressure control volume guarantee ventilation will be adjusted to maintain normocapnia Anesthesia will be maintained by using 1-15 isoflurane in a mixture of oxygen and air 5050 and atracurium top ups at a dose of 01mgkg every 30 minutes
All participants will be given 1 gram of intravenous paracetamol with maximum dose of 4 gm every 24 hour Failed block increase in HR and mean arterial blood pressure MABP20 from base line with skin incision will be treated by 1ug kg of fentanyl as top-up doses and increasing isoflurane concentration in case of inadequate response to fentanyl
20 minute before the end of the surgery ketorolac 05mgkg diluted in 100 ml of saline will be given intravenously After skin closure inhalational anesthesia will be discontinued and reversal of muscle relaxation with atropine 002 mgKg and neostigmine 005 mgKg will be administered intravenous after return of patients spontaneous breathing Patients will then be transferred to post anesthesia care unit PACU for 60 min to complete recovery and monitoring
At any time hypotension defined as a decrease in mean arterial pressure MAP 20 from baseline value or systolic arterial pressure SAP 100 mmHg will be treated with 5 mg IV bolus ephedrine and repeated every 3 minutes until the hypotension resolved Bradycardia defined as a HR 40 beats per minute will be treated with atropine 05 mg IV11
Cpostoperative
In the PACU VAS will be assessed 15 min after extubation and when the score exceeds 310 rescue analgesia in the form of nalbuphine 01 mgKg with maximum dose of 30 mg every 24 hours will be given Another dose of nalbuphine 01 mgkg can be given in the PACU if the score still more than 3 after 30 min of the 1st dose
After discharging from the PACU the analgesic plan will be intravenous paracetamol one gram every 8 hours ketorolac 05mgkg 6 hours if VAS score 3 and nalbuphine as second rescue analgesia 01 mgkg 8 hours as long as the pain score is more than 310 reassessment to be done after 30 mins of administration of first rescue analgesia
3 Measurement tools
Patients characteristics including patients age in years weight in kilogramsBMI gender type of surgery
All hemodynamic parameters as blood pressure using non-invasive measurement heart rate oxygen saturation will be recorded at baseline 5 mins after intubation every 10 min till the end of the surgery immediately after extubation 5 min after extubation and every 10 mins in PACU for 30 min till the discharge of the patient
Failed blocks will be documented patient requirement of consecutive rescue analgesia
the patients will be evaluated regarding the time to first demand to rescue analgesia postoperatively
The pain will be assessed by the VAS score It will be performed in the immediate post-operative period every 30 min for the first hour 2 h 4 h 8h 12h and 24 h Breakthrough pain will be defined as VAS 3 at rest
Pain will be classified as mild VAS 1-3 moderate VAS 4-6 and severe VAS 7-10
Postoperative regular analgesia will be prescribed for all patients in the form of paracetamol every 8 hours Rescue analgesia will be administered if VAS is 3 at any time with IV ketorolac 05 mgkg diluted in 100 ml normal saline and administered slowly every 6 hours
Reassessment of VAS score will be done and if VAS is still 3 the second rescue analgesic planned will be IV nalbuphine 01 mgkg every 8 hours
The time interval between the first and the second rescue analgesia will be 30 minutes if VAS score remains persistently 3
Time at which the patient start to ambulate in both groups will be recorded 12
PONV in first 24hr will be monitored and documented if occurred
complications such as hematoma at the site of injection and local anesthetic toxicity will be documented
Quality of recovery questionnaireQoR15
VI Study outcomes
1 Primary outcome Total opioid consumption morphine equivalent dose in both groups in 24hr postoperative including Intraoperative fentanyl and postoperative nalluphine
2 Secondary outcomes
1 VAS score during first 24 hour postoperative
2 Failure rate in performing the block
3 Patient demographic data age sex ASA classification BMI and type of surgery
4 Postoperative nausea and vomiting in first 24 hours
5 Time at which the patient start to ambulate in both groups
6 Haemodynamic parameters heartrateBlood pressure recorded intraoperative immediately postoperatively and in PAICU
7 Incidence of complications related to the block as infection or hematoma at the site of injection local anaesthetic toxicity or pneumothorax
8 Time for first rescue analgesia in both groups
9 Quality of recovery questionnaire QoR15 after 24hr from the end of the surgery
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?:
False
Is an FDA AA801 Violation?:
None