The Visceral Analgesic Effect of Erector Spinae Plane Block in Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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The purpose of this study was to investigate the effectiveness of erector spinae plane block on postoperative visceral pain in laparoscopic cholecystectomy (LLC). Given that rectus sheath block may provide sufficient somatic pain block, investigators aimed to investigate whether erector spinae block is effective in visceral pain block. After induction of general anesthesia, group of patient is decided randomly. In Group R, rectus sheath block is performed with 0.2% Ropivacaine 30ml before the operation. In Group RE, rectus sheath block and erector spinae plane block are performed with 0.2% ropivacaine 70ml before the operation. NRS score measurement and comparison of the rescue analgesic dose used at 0, 0.5, 1, 2,6, 12, 18, and 24 hours after arrival at the recovery room were collected

Official Title
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The Visceral Analgesic Effect of Erector Spinae Plane Block in Laparoscopic Cholecystectomy

Conditions
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Visceral Pain, Postoperative

Intervention / Treatment
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* Drug: Ultrasound guided Rectus sheath block
* Drug: Ultrasound erector spinae plane block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults between the ages of 20 and 80 scheduled laparoscopic cholecystectomy patient American society of anesthesiologists score 1 or 2 Patients who have voluntarily agreed in writing to participate in the trial Exclusion Criteria: Patient with side effects on local anesthetics or steroids Patient who are taboo of peripheral nerve block such as blood clotting disorder, infection, etc. Patients with uncontrolled medical or psychiatric problem Patient does not agree to participate in the study Patients with deformity at vertebra or chest wall. Patients who are pregnant or lactating Patients receiving a single laparoscopic cholecystectomy (including using a robot) Patients with severe intraperitoneal adhesion (higher than Nair s grade 3), or with external drain.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group R : Rectus sheath block group<br>ultrasound guided Rectus sheath block with 0.2% ropivacaine (Fresenius Kabi) 30ml before surgical incision | Drug: Ultrasound guided Rectus sheath block<br>* Ultrasound guided rectus sheath block with 0.2% ropivacaine (Fresenius Kabi) 30ml around umbilicus<br>|
| Active Comparator: Group RE: Rectus sheath block and erector spinae plane block<br>ultrasound guided Rectus sheath block with 0.2% ropivacaine (Fresenius Kabi) 30ml before surgical incision and ultrasound guided erector spinae plane block with 0.2% ropivacaine (Fresenius Kabi) 40ml | Drug: Ultrasound guided Rectus sheath block<br>* Ultrasound guided rectus sheath block with 0.2% ropivacaine (Fresenius Kabi) 30ml around umbilicus<br>Drug: Ultrasound erector spinae plane block<br>* Ultrasound guided erector spinae plane block with 0.2% ropivacaine (Fresenius Kabi) 40ml at T7 level<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of analgesic consumption between both group | The difference in analgesics usage between the two groups after the operation is checked at fixed intervals (at 0, 0.5, 1, 2, 6, 12, 18, 24 hours after operation) to compare. | at 0, 0.5, 1, 2, 6, 12, 18, 24 hours after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compare the Numeric rating scale (NRS) | 10 years old or older. 0: No pain, 1-3: mild pain, 4-6: Moderate pain, 7-10: severe pain, 10: worst pain imaginable. After surgery, the NRS differences between the two groups were compared at a constant interval (0, 0.5, 1, 2, 6, 12, 18, 24 hours postoperatively). | at 0, 0.5, 1, 2, 6, 9, 18, 24 hours after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopic cholecystectomy, erector spinae plane block, visceral pain