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

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04648345
• Other study ID #: 20004-0-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2020
• Est. completion date: May 2021

Study information

• Verified date: November 2020
• Source: Beijing Tsinghua Chang Gung Hospital
• Contact: Siyi YAN, MD
• Phone: 86+010-56119610
• Email: yansiyi03[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: May 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia

Intervention

Procedure:
• Erector spinal plane block
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tsinghua Chang Gung Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	The overall dose of remifentanil	The overall dose of remifentanil used in the surgery.	During the surgery