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

NCT ID: NCT04648345

Last Updated: 2020-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-31

Study Completion Date

2021-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Analgesia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

erector spinal plane block analgesia laparoscopic cholecystectomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized, single-blinded, controlled clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Erector spinal plane block group (ESPB group)

After induction of general anesthesia, pre-operative ultrasound-guided bilateral erector spinae plane block will be performed in the ESPB group.

Group Type EXPERIMENTAL

Erector spinal plane block

Intervention Type 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.

Vertebral side block group (VSB group)

After induction of general anesthesia, pre-operative ultrasound-guided bilateral vertebral side block will be performed in the VSB group.

Group Type ACTIVE_COMPARATOR

Erector spinal plane block

Intervention Type 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.

Local block group (LB group)

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

Group Type PLACEBO_COMPARATOR

Erector spinal plane block

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Vertebral side block Local block

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beijing Tsinghua Chang Gung Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Siyi YAN, MD

Role: CONTACT

Phone: 86+010-56119610

Email: [email protected]

Chen Yu, MD

Role: CONTACT

Phone: 86+010-56119353

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20004-0-01

Identifier Type: -

Identifier Source: org_study_id