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

B

Beijing Tsinghua Chang Gung Hospital

Status

Unknown

Conditions

Analgesia

Treatments

Procedure: Erector spinal plane block

Study type

Interventional

Funder types

Other

Identifiers

NCT04648345
20004-0-01

Details and patient eligibility

About

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.

Enrollment

90 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

90 participants in 3 patient groups, including a placebo group

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

Trial contacts and locations

0

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Central trial contact

Siyi YAN, MD; Chen Yu, MD

Data sourced from clinicaltrials.gov

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