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

Not Applicable

• Conditions: Analgesia
• Interventions: Procedure: Erector spinal plane block

• Registration Number: NCT04648345
• Lead Sponsor: Beijing Tsinghua Chang Gung Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-11
• Study First Submitted: 2020-11-03
• Study First Submitted QC: 2020-11-23
• Last Update Submitted: 2020-11-23
• Study Start: 2020-12
• Study First Posted: 2020-12-01
• Last Update Posted: 2020-12-01
• Primary Completion: 2021-03
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Erector spinal plane block group (ESPB group)	Erector spinal plane block	After induction of general anesthesia, pre-operative ultrasound-guided bilateral erector spinae plane block will be performed in the ESPB group.
Local block group （LB group）	Erector spinal plane block	Local block will be performed at the surgical incisions after the surgery under general anesthesia.
Vertebral side block group (VSB group)	Erector spinal plane block	After induction of general anesthesia, pre-operative ultrasound-guided bilateral vertebral side block will be performed in the VSB group.

Primary Outcome Measures

Name	Time	Method
Pain intensity at rest(Hour 2)	Hour 2	Using the Numeric Rating Scale (NRS) to evaluate the pain intensity at rest two hours after the surgery.
Pain intensity at rest (Hour 6)	Hour 6	Using the Numeric Rating Scale (NRS) to evaluate the pain intensity at rest six hours after the surgery.
Pain intensity at rest (Hour 24)	Hour 24	Using the Numeric Rating Scale (NRS) to evaluate the pain intensity at rest 24 hours after the surgery.

Secondary Outcome Measures

Name	Time	Method
The overall dose of remifentanil	During the surgery	The overall dose of remifentanil used in the surgery.