Skip to main content
OpenTrials
Completed

NCT Number: NCT03413280

Preemptive Analgesic Effects of Rectus Sheath Block in Laparoscopic Cholecystectomy Patients

The purpose of this study was to investigate the effectiveness of preemptive effect of rectus sheath block (RSB) and intercostal nerve block (ICNB) on postoperative visceral pain in laparoscopic cholecystectomy (LLC).

After induction of general anesthesia, group of patient is decided randomly. In Group pre, RSB and ICNB are performed with 0.25% Ropivacaine 40ml before the operation. In Group post, RSB and ICNB are performed with 0.25% Ropivacaine 40ml after the operation.

Measure the NRS and compare the rescue analgesic dose used at 0, 0.5, 1, 2, 6, 9, 18, and 24 hours after arrival at the recovery room.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Preemptive Peripheral Nerve Block Acute Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

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
  • ASA class 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 who are pregnant or lactating
  • Patients whose visceral pain is expected to be too severe
  • Patients receiving a single laparoscopic cholecystectomy (including using a robot)

Treatment and study plan

Ultrasound guided Rectus sheath block

Drug

Ultrasound guided rectus sheath block with 0.25% ropivacaine 34ml around umbilicus

Intercostal nerve block

Drug

Ultrasound guided intercostal nerve block with 0.25% ropivacaine 6ml in 7,8,9 th intercostal space

Primary outcomes

  1. Difference of analgesic consumption between both group

    Time frame: at 0, 0.5, 1, 2, 6, 9, 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, 9, 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

    The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 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, 9, 18, 24 hours postoperatively).

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

The Effectiveness of Preemptive Effect of Rectus Sheath Block and Intercostal Block on Postoperative Visceral Pain in Laparoscopic Cholecystectomy

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Jan 29, 2018
Registry last updated
Jan 23, 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.