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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04648345

Enrollment

Registered

2020-12-01

Start date

2020-12-31

Completion date

2021-05-31

Last updated

2020-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia

Keywords

erector spinal plane block, analgesia, laparoscopic cholecystectomy

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.

Interventions

PROCEDUREErector 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

A randomized, single-blinded, controlled clinical trial

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
The overall dose of remifentanil	During the surgery	The overall dose of remifentanil used in the surgery.

Contacts

Primary ContactSiyi YAN, MD

yansiyi03@hotmail.com86+010-56119610

Backup ContactChen Yu, MD

yca01089@btch.edu.cn86+010-56119353

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026