Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06322316
Status:
COMPLETED
Last Update Posted:
2024-03-21
First Post:
2024-03-05
Brief Title:
Analgesic Efficacy of US Retrolaminar Block and Erector Spinae Plane Block in MRM
Sponsor:
National Cancer Institute Egypt
Organization:
National Cancer Institute Egypt
Study Overview
Official Title:
Analgesic Efficacy of Ultrasound-guided Retrolaminar Block and Erector Spinae Plane Block in Modified Radical Mastectomy A Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2024-03
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:
Modified radical mastectomy MRM is the most commonly performed surgical procedure in breast cancer patients and is usually associated with severe postoperative pain The peripheral nerve block techniques were suggested to reduce acuter post-mastectomy pain The study compared the analgesic efficacy of retrolaminar block RLB and ESPB in patients undergoing MRM
Detailed Description:
Introduction Globally breast cancer remains the most prevalent cancer among females with an estimated incidence of 31 and mortality of 15 Surgery is foremost in managing breast cancer where modified radical mastectomy MRM is the most commonly performed procedure This procedure implicates vigorous tissue dissection and seroma formation with many postoperative complications Pain is the main complaint following MRM affecting up to 50 of women and 25-60 develop persistent chronic postmastectomy pain
Therefore adequate pain control is crucial to postoperative management after MRM Numerous analgesic methods were suggested to reduce acuter post-mastectomy pain Opioid-related adverse events include nausea and vomiting respiratory depression sedation and dizziness
Most mastectomy-related pain originates from the chest walls sensory nerves The peripheral nerve block techniques have gained increased interest in treating postoperative pain The erector spinae plane block ESPB is one of these techniques that proved effective in various surgical procedures including breast surgery It encompasses injecting the local anesthetic LA solution deep into the erector spinae muscle ESM which eventually spreads through the paravertebral space Ultrasound-guided retrolaminar block RLB is another approach that was found to be effective for pain relief after thoracic surgery In RLB LA is injected into the space between the ESM and the lamina of the thoracic vertebra
Both techniques are considered variants of paravertebral block however prospective studies comparing RLB and ESPB are limited Therefore this study was designed to compare the analgesic efficacy of ultrasound-guided retrolaminar block and erector spinae plane block in patients undergoing modified radical mastectomy
Patients and Methods
This randomized single-blinded study was conducted at the National Cancer Institute NCI Cairo University from October 2022 and finished March 2023 The study was approved by the institutional review board and the scientific committee of the anesthesia department of the NCI and Faculty of Medicine Cairo University All participants provided written informed consent before enrollment in the study after fully explaining the procedures and possible complications
The study involved 60 female patients scheduled for MRM under general anesthesia with the following inclusion criteria age 18 to 65 ASA class II or III and body mass index BMI of 20-35 kgm2 Patients with known sensitivity or contraindication to the drugs used in the study history of psychological disorders or chronic pain syndromes contraindication to regional anesthesia local sepsis pre-existing peripheral neuropathies coagulopathy severe respiratory or cardiac conditions advanced liver or kidney disease were excluded from the study
The patients were randomly allocated into one of two equal groups using computer-generated random numbers in opaque closed envelopes An independent statistician performed the randomization The grouping was revealed only when the patient was transferred to the pre-anesthetic room The RLB Group n30 received a preoperative ultrasound-guided retrolaminar block using 20 ml levobupivacaine 025 The ESPB Group n30 received a preoperative ultrasound-guided erector spinae plane block using 20 ml levobupivacaine 025
Preoperative assessment included thorough history taking physical examination and laboratory and radiological investigations The patients were instructed to report pain using the Numeric Pain Rating Scale NPRS where 0 no pain and 10 worst imaginable pain All patients were premedicated with IV midazolam 001-002 mgkg 30 minutes before surgery In both blocks a Fujifilm Sonosite M-Turbo Ultrasound system linear probe was used SN04RQZ6 After performing blocks lung ultrasound was performed to exclude pneumothorax
Retrolaminar Block Technique The block was performed under complete aseptic precautions The ultrasound probe was placed on the back in a transverse orientation on the lateral side of the posterior median line to identify the lamina of the 5th vertebra ESM and transversospinalis muscles of the target segment A skin wheal using 3 ml of 1 lidocaine was made 2-3 cm medial to the transducer A 38-mm 22-gauge regional block needle was advanced using an in-plane technique When the puncture needle touched the lamina with no blood gas or cerebrospinal fluid observed on aspiration 20 mL of 025 levobupivacaine was administered between the transversospinalis muscle and lamina The LA diffusion between the lamina and the ESM indicated a successful puncture
Erector spinae plane block
The ultrasound probe was placed on the back in a transverse orientation to identify the tip of the T5 transverse process as flat squared-off acoustic shadows with a faint image of the pleura visible When the tip of the transverse process was centered on the ultrasound screen the probe was rotated to a longitudinal orientation In the parasagittal view the following layers were visible superficial to the acoustic shadows of the transverse processes skin and subcutaneous tissue trapezius ESM and T5 transverse process A skin wheal was made using 3 ml of 1 lidocaine then the block needle was inserted in-plane in a cranial-to-caudal direction until contact was made with the T5 transverse process The correct location of the needle tip in the fascial plane deep to the ESM was confirmed by injecting 05-10 ml of normal saline and seeing the fluid lifting the ESM off the transverse process without distending the muscle After aspiration to avoid intravascular injection 20 ml levobupivacaine 025 was injected
Anesthetic Management
All patients were monitored continuously using electrocardiography non-invasive blood pressure peripheral O2 saturation temperature probe and end-tidal CO2 throughout the surgical procedure Anesthesia was induced using fentanyl 2 μgkg and propofol 2 mgkg IV Tracheal intubation was facilitated using rocuronium 05 mgkg IV Anesthesia was maintained with inhaled sevoflurane 20-25 in oxygen-enriched air FiO205 Maintenance doses of rocuronium 01 mgkg were provided every 30 minutes Paracetamol 500 mg and ketorolac 30 mg were provided as a part of multimodal analgesia Rescue analgesia of fentanyl 1 μgkg was given if the mean arterial blood pressure MAP or heart rate HR rose above 20 of baseline levels The patients were mechanically ventilated at appropriate settings to keep end-tidal CO2 at 30-35 mmHg
The first reading of MAP and HR was taken before induction of general anesthesia as a baseline reading Then another reading was taken immediately before incision and at 30-minute intervals intraoperatively Hypotension reduction 20 of baseline reading was treated with 09 normal saline andor 5 mg ephedrine in incremental doses to maintain MAP above 70 mmHg The residual neuromuscular blockade was reversed using neostigmine 005 mgkg and atropine 002 mgkg Extubation was performed after complete recovery of the airway reflexes
Postoperatively the NPRS score MAP and HR were noted immediately on arrival and every 2 hours Multimodal analgesia was provided as paracetamol 500 mg6 hours and ketorolac 30 mg8 hours IV Rescue analgesia was provided as IV morphine 3 mg boluses when the patient indicated an NPRS score 4 The total amount of morphine given in 24 hours was recorded and a maximum dose of 05 mgkg24 hours of morphine was allowed Side effects such as nausea vomiting sedation hallucination and respiratory depression respiratory rate 10minute were recorded Moderate or severe postoperative nausea and vomiting PONV was treated with 01 mgkg of IV ondansetron
Therefore adequate pain control is crucial to postoperative management after MRM Numerous analgesic methods were suggested to reduce acuter post-mastectomy pain Opioid-related adverse events include nausea and vomiting respiratory depression sedation and dizziness
Most mastectomy-related pain originates from the chest walls sensory nerves The peripheral nerve block techniques have gained increased interest in treating postoperative pain The erector spinae plane block ESPB is one of these techniques that proved effective in various surgical procedures including breast surgery It encompasses injecting the local anesthetic LA solution deep into the erector spinae muscle ESM which eventually spreads through the paravertebral space Ultrasound-guided retrolaminar block RLB is another approach that was found to be effective for pain relief after thoracic surgery In RLB LA is injected into the space between the ESM and the lamina of the thoracic vertebra
Both techniques are considered variants of paravertebral block however prospective studies comparing RLB and ESPB are limited Therefore this study was designed to compare the analgesic efficacy of ultrasound-guided retrolaminar block and erector spinae plane block in patients undergoing modified radical mastectomy
Patients and Methods
This randomized single-blinded study was conducted at the National Cancer Institute NCI Cairo University from October 2022 and finished March 2023 The study was approved by the institutional review board and the scientific committee of the anesthesia department of the NCI and Faculty of Medicine Cairo University All participants provided written informed consent before enrollment in the study after fully explaining the procedures and possible complications
The study involved 60 female patients scheduled for MRM under general anesthesia with the following inclusion criteria age 18 to 65 ASA class II or III and body mass index BMI of 20-35 kgm2 Patients with known sensitivity or contraindication to the drugs used in the study history of psychological disorders or chronic pain syndromes contraindication to regional anesthesia local sepsis pre-existing peripheral neuropathies coagulopathy severe respiratory or cardiac conditions advanced liver or kidney disease were excluded from the study
The patients were randomly allocated into one of two equal groups using computer-generated random numbers in opaque closed envelopes An independent statistician performed the randomization The grouping was revealed only when the patient was transferred to the pre-anesthetic room The RLB Group n30 received a preoperative ultrasound-guided retrolaminar block using 20 ml levobupivacaine 025 The ESPB Group n30 received a preoperative ultrasound-guided erector spinae plane block using 20 ml levobupivacaine 025
Preoperative assessment included thorough history taking physical examination and laboratory and radiological investigations The patients were instructed to report pain using the Numeric Pain Rating Scale NPRS where 0 no pain and 10 worst imaginable pain All patients were premedicated with IV midazolam 001-002 mgkg 30 minutes before surgery In both blocks a Fujifilm Sonosite M-Turbo Ultrasound system linear probe was used SN04RQZ6 After performing blocks lung ultrasound was performed to exclude pneumothorax
Retrolaminar Block Technique The block was performed under complete aseptic precautions The ultrasound probe was placed on the back in a transverse orientation on the lateral side of the posterior median line to identify the lamina of the 5th vertebra ESM and transversospinalis muscles of the target segment A skin wheal using 3 ml of 1 lidocaine was made 2-3 cm medial to the transducer A 38-mm 22-gauge regional block needle was advanced using an in-plane technique When the puncture needle touched the lamina with no blood gas or cerebrospinal fluid observed on aspiration 20 mL of 025 levobupivacaine was administered between the transversospinalis muscle and lamina The LA diffusion between the lamina and the ESM indicated a successful puncture
Erector spinae plane block
The ultrasound probe was placed on the back in a transverse orientation to identify the tip of the T5 transverse process as flat squared-off acoustic shadows with a faint image of the pleura visible When the tip of the transverse process was centered on the ultrasound screen the probe was rotated to a longitudinal orientation In the parasagittal view the following layers were visible superficial to the acoustic shadows of the transverse processes skin and subcutaneous tissue trapezius ESM and T5 transverse process A skin wheal was made using 3 ml of 1 lidocaine then the block needle was inserted in-plane in a cranial-to-caudal direction until contact was made with the T5 transverse process The correct location of the needle tip in the fascial plane deep to the ESM was confirmed by injecting 05-10 ml of normal saline and seeing the fluid lifting the ESM off the transverse process without distending the muscle After aspiration to avoid intravascular injection 20 ml levobupivacaine 025 was injected
Anesthetic Management
All patients were monitored continuously using electrocardiography non-invasive blood pressure peripheral O2 saturation temperature probe and end-tidal CO2 throughout the surgical procedure Anesthesia was induced using fentanyl 2 μgkg and propofol 2 mgkg IV Tracheal intubation was facilitated using rocuronium 05 mgkg IV Anesthesia was maintained with inhaled sevoflurane 20-25 in oxygen-enriched air FiO205 Maintenance doses of rocuronium 01 mgkg were provided every 30 minutes Paracetamol 500 mg and ketorolac 30 mg were provided as a part of multimodal analgesia Rescue analgesia of fentanyl 1 μgkg was given if the mean arterial blood pressure MAP or heart rate HR rose above 20 of baseline levels The patients were mechanically ventilated at appropriate settings to keep end-tidal CO2 at 30-35 mmHg
The first reading of MAP and HR was taken before induction of general anesthesia as a baseline reading Then another reading was taken immediately before incision and at 30-minute intervals intraoperatively Hypotension reduction 20 of baseline reading was treated with 09 normal saline andor 5 mg ephedrine in incremental doses to maintain MAP above 70 mmHg The residual neuromuscular blockade was reversed using neostigmine 005 mgkg and atropine 002 mgkg Extubation was performed after complete recovery of the airway reflexes
Postoperatively the NPRS score MAP and HR were noted immediately on arrival and every 2 hours Multimodal analgesia was provided as paracetamol 500 mg6 hours and ketorolac 30 mg8 hours IV Rescue analgesia was provided as IV morphine 3 mg boluses when the patient indicated an NPRS score 4 The total amount of morphine given in 24 hours was recorded and a maximum dose of 05 mgkg24 hours of morphine was allowed Side effects such as nausea vomiting sedation hallucination and respiratory depression respiratory rate 10minute were recorded Moderate or severe postoperative nausea and vomiting PONV was treated with 01 mgkg of IV ondansetron
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