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

NCT04648345 | Unknown

• 1 other identifier: 20004-0-01
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Analgesia

Keywords

erector spinal plane block; analgesia; laparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• The overall dose of remifentanil

  During the surgery

Study Arms (3)

Erector spinal plane block group (ESPB group)

EXPERIMENTAL

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

Vertebral side block group (VSB group)

ACTIVE COMPARATOR

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

Local block group （LB group）

PLACEBO COMPARATOR

Local block will be performed at the surgical incisions after the surgery under general anesthesia.

Procedure: Erector spinal plane block

Interventions

Erector spinal plane block PROCEDURE

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.

Also known as: Vertebral side block, Local block

Erector spinal plane block group (ESPB group); Local block group （LB group）; Vertebral side block group (VSB group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status 1-3
• Scheduled for elective laparoscopic cholecystectomy surgery under general anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Siyi YAN, MD

CONTACT

86+010-56119610; yansiyi03@hotmail.com

Chen Yu, MD

CONTACT

86+010-56119353; yca01089@btch.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized, single-blinded, controlled clinical trial

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: December 1, 2020
• Study Start: December 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: May 1, 2021
• Last Updated: December 1, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share