Skip to main content
OpenTrials
Completed

NCT Number: NCT03767816

The Visceral Analgesic Effect of Erector Spinae Plane Block in Laparoscopic Cholecystectomy

The purpose of this study was to investigate the effectiveness of erector spinae plane block on postoperative visceral pain in laparoscopic cholecystectomy (LLC). Given that rectus sheath block may provide sufficient somatic pain block, investigators aimed to investigate whether erector spinae block is effective in visceral pain block.

After induction of general anesthesia, group of patient is decided randomly. In Group R, rectus sheath block is performed with 0.2% Ropivacaine 30ml before the operation. In Group RE, rectus sheath block and erector spinae plane block are performed with 0.2% ropivacaine 70ml before the operation.

NRS score measurement and comparison of the rescue analgesic dose used at 0, 0.5, 1, 2,6, 12, 18, and 24 hours after arrival at the recovery room were collected

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Visceral Pain, Postoperative Neurologic Manifestations Nociceptive Pain Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Visceral Pain

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asan Medical Center

Seoul, Songpa-gu, 05505, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adults between the ages of 20 and 80
  • scheduled laparoscopic cholecystectomy patient
  • American society of anesthesiologists score 1 or 2
  • Patients who have voluntarily agreed in writing to participate in the trial

Exclusion criteria

  • Patient with side effects on local anesthetics or steroids
  • Patient who are taboo of peripheral nerve block such as blood clotting disorder, infection, etc.
  • Patients with uncontrolled medical or psychiatric problem
  • Patient does not agree to participate in the study
  • Patients with deformity at vertebra or chest wall.
  • Patients who are pregnant or lactating
  • Patients receiving a single laparoscopic cholecystectomy (including using a robot)
  • Patients with severe intraperitoneal adhesion (higher than Nair s grade 3), or with external drain.

Treatment and study plan

Ultrasound guided Rectus sheath block

Drug

Ultrasound guided rectus sheath block with 0.2% ropivacaine (Fresenius Kabi) 30ml around umbilicus

Ultrasound erector spinae plane block

Drug

Ultrasound guided erector spinae plane block with 0.2% ropivacaine (Fresenius Kabi) 40ml at T7 level

Primary outcomes

  1. Difference of analgesic consumption between both group

    Time frame: at 0, 0.5, 1, 2, 6, 12, 18, 24 hours after operation

    The difference in analgesics usage between the two groups after the operation is checked at fixed intervals (at 0, 0.5,

    1, 2, 6, 12, 18, 24 hours after operation) to compare.

Secondary outcomes

  1. compare the Numeric rating scale (NRS)

    Time frame: at 0, 0.5, 1, 2, 6, 9, 18, 24 hours after operation

    10 years old or older. 0: No pain, 1-3: mild pain, 4-6: Moderate pain, 7-10: severe pain, 10: worst pain imaginable.

    After surgery, the NRS differences between the two groups were compared at a constant interval (0, 0.5, 1, 2, 6, 12, 18, 24 hours postoperatively).

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 7, 2018
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.