Erector Spinae Plan Block for Postoperative Analgesia

Study Overview
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Brief Summary
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Laparoscopic cholecystectomy is a widely employed procedure in ambulatory surgery. Pain after laparoscopic cholecystectomy arises significantly from port site incisions in the anterior abdominal wall. Innervation of the anterior abdominal wall is segmentally supplied by pain afferents in the plane of fascia between transversus abdominis and the internal oblique muscles. Opioids analgesia is used to control postoperative pain, but it carries the risk of increased nausea and vomiting, ileus and sedation that may delay hospital discharge. Several techniques have been tried as.neuroaxial narcotics, intraperitoneal lavage of local anesthetic and transversus abdominis plan (TAP) block and successfully reduced opioid use and improve postoperative analgesia. The ultrasound-guided erector spinae plan(ESP) block is a recently described technique which produces reliable unilateral analgesia at thoraco-lumbar dermatomes. ESP block carries the advantages of being simple, safe, easily recognizable by ultrasound, and a catheter can be threaded to extend the duration of analgesia. Few case series reported the efficacy of (US)-guided ESP blocks in reducing postoperative pain and opioids consumption. Because of that, the investigators aimed to test the hypothesis that US-guided ESP blocks can decrease opioid consumption during the first 24 h after of laparoscopic cholecystectomy in comparison with the conventional systemic analgesia.

Official Title
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Efficacy of Ultrasound-Guided Erector Spinae Plan Block on Postoperative Pain After Laparoscopic Cholecystectomy Under General Anesthesia. Randomized, Controlled Trial

Conditions
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Postoperative Pain

Intervention / Treatment
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* Procedure: Erector Spinae Plan Block
* Procedure: Oblique subcostal TAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 60 ASA I- II adult patients 20-60 years old elective laparoscopic cholecystectomy Body mass index (BMI) less than 35 Port sites at or above thoracic T 10 dermatome Exclusion Criteria: Allergy to amino-amide local anesthetics Presence of coagulopathy Local skin infection at the needle puncture sites Preoperative chronic dependence upon opioid and NSAID medications Liver or renal insufficiency History of psychiatric or neurological disease Deafness previous open surgery that need the conversion of laparoscopic to open surgery or manipulations more than expected with more tissue trauma American Society of Anesthesiologists (ASA) above Class II

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group I (Control)<br>ultrasound guided Bilateral Erector Spinae Plan Block using isotonic saline | Procedure: Erector Spinae Plan Block<br>* The trocar site incision was done 15 minutes after the block in the three groups. The skin was disinfected with chlorhexidine solution, and the high-frequency transducer was isolated with a sterile disposable plastic cover and gel. The patient was placed in lateral position. A high-frequency linear ultrasound probe was placed longitudinally lateral to the T8 spinous process by 3 cm. After identification of the 3 muscles superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. The needle was introduced in a cephalo-caudal orientation. The needle tip was positioned fascial plane between rhomboid major and erector spinae muscles. Hydrodissection by 1-2 ml of normal saline to visualize the plan, then deposition of local anesthetic was done. A total of 20 mL of 0.25% bupivacaine was injected here. The same procedure was repeated on the other side.<br>|
| Active Comparator: Group II (ESP)<br>ultrasound guided Bilateral Erector Spinae Plan Block with bupivacaine 0.25% | Procedure: Erector Spinae Plan Block<br>* The trocar site incision was done 15 minutes after the block in the three groups. The skin was disinfected with chlorhexidine solution, and the high-frequency transducer was isolated with a sterile disposable plastic cover and gel. The patient was placed in lateral position. A high-frequency linear ultrasound probe was placed longitudinally lateral to the T8 spinous process by 3 cm. After identification of the 3 muscles superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. The needle was introduced in a cephalo-caudal orientation. The needle tip was positioned fascial plane between rhomboid major and erector spinae muscles. Hydrodissection by 1-2 ml of normal saline to visualize the plan, then deposition of local anesthetic was done. A total of 20 mL of 0.25% bupivacaine was injected here. The same procedure was repeated on the other side.<br>|
| Active Comparator: Group III(OSTAP)<br>Ultrasound-guided bilateral oblique subcostal TAP block | Procedure: Oblique subcostal TAP<br>* ultrasound-guided bilateral oblique subcostal TAP block with bupivacaine 0.25% (20ml on each side)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine consumption | It was calculated as equivalent morphine dose to the opioid analgesia consumed | 24 hours postoperatively. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of analgesia | comparing visual analog scores (VAS) every two hours after surgery | Every 2 hours for 24 hours postoperatively | 
| The intraoperative fentanyl | (µg) required during surgery | 2 hours | 
| equivalent morphine dose in the recovery unit (PACU) | equivalent morphine dose in the recovery unit (PACU) | one hour | 
| Erector spinae plan block complications | local anesthetic systemic toxicity, vascular injury, and intravascular injection of local anesthetic | 24 hours postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erecror Spinae Plan Block, postoperative pain, Laparoscopic cholecystectomy