Efficacy and Safety of Erector Spinal Plane Block (ESPB) for Analgesia in Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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Purpose: to evaluate the efficacy and safety of erector spinal block (ESB) for analgesia in laparoscopic cholecystectomy（LC）. Method: This study is a randomized, single-blind, controlled clinical trial. Pre-operative ultrasound-guided bilateral erector spinae plane block will be performed in the ESPB group. Vertebral side block will be performed in the VSB group. And the control group will receive local anaesthesia after the surgery. Intraoperative and postoperative analgesia effect and side effects will be compared between the three groups.

Official Title
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Efficacy and Safety of Erector Spinal Plane Block (ESPB) for Intraoperative and Postoperative Analgesia in Laparoscopic Cholecystectomy : A Randomized, Single-blind，Controlled Clinical Trial.

Conditions
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Analgesia

Intervention / Treatment
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* Procedure: Erector spinal plane block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status 1-3 Scheduled for elective laparoscopic cholecystectomy surgery under general anesthesia Exclusion Criteria: patient refusal pregnancy history of allergy to study drugs neurological and cognitive disorders coagulopathy chronic pain disorders infections at the injection site history of abdominal surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized, single-blinded, controlled clinical trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erector spinal plane block group (ESPB group)<br>After induction of general anesthesia, pre-operative ultrasound-guided bilateral erector spinae plane block will be performed in the ESPB group. | Procedure: Erector spinal plane block<br>* After induction of general anesthesia, pre-operative ultrasound-guided bilateral erector spinae plane block/ vertebral side block will be performed in the ESPB/VSB group. Local block will be performed at the surgical incisions after the surgery under general anesthesia. All the intervention will be performed without patients' awareness.<br>* Other names: Local block;|
| Active Comparator: Vertebral side block group (VSB group)<br>After induction of general anesthesia, pre-operative ultrasound-guided bilateral vertebral side block will be performed in the VSB group. | Procedure: Erector spinal plane block<br>* After induction of general anesthesia, pre-operative ultrasound-guided bilateral erector spinae plane block/ vertebral side block will be performed in the ESPB/VSB group. Local block will be performed at the surgical incisions after the surgery under general anesthesia. All the intervention will be performed without patients' awareness.<br>* Other names: Local block;|
| Placebo Comparator: Local block group （LB group）<br>Local block will be performed at the surgical incisions after the surgery under general anesthesia. | Procedure: Erector spinal plane block<br>* After induction of general anesthesia, pre-operative ultrasound-guided bilateral erector spinae plane block/ vertebral side block will be performed in the ESPB/VSB group. Local block will be performed at the surgical incisions after the surgery under general anesthesia. All the intervention will be performed without patients' awareness.<br>* Other names: Local block;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity at rest(Hour 2) | Using the Numeric Rating Scale (NRS) to evaluate the pain intensity at rest two hours after the surgery. | Hour 2 | 
| Pain intensity at rest (Hour 6) | Using the Numeric Rating Scale (NRS) to evaluate the pain intensity at rest six hours after the surgery. | Hour 6 | 
| Pain intensity at rest (Hour 24) | Using the Numeric Rating Scale (NRS) to evaluate the pain intensity at rest 24 hours after the surgery. | Hour 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The overall dose of remifentanil | The overall dose of remifentanil used in the surgery. | During the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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erector spinal plane block, analgesia, laparoscopic cholecystectomy