search
Back to results

Preemptive Analgesic Effects of Rectus Sheath Block in Laparoscopic Cholecystectomy Patients

Primary Purpose

Preemptive Peripheral Nerve Block, Pain, Postoperative, Acute Pain

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ultrasound guided Rectus sheath block
Intercostal nerve block
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preemptive Peripheral Nerve Block focused on measuring preemptive analgic effect, Rectus Sheath Block, laparoscopic cholecystectomy

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. adults between the ages of 20 and 80
  2. scheduled laparoscopic cholecystectomy patient
  3. ASA class 1 or 2
  4. Patients who have voluntarily agreed in writing to participate in the trial

Exclusion Criteria:

  1. Patient with side effects on local anesthetics or steroids
  2. Patient who are taboo of peripheral nerve block such as blood clotting disorder, infection, etc.
  3. Patients with uncontrolled medical or psychiatric problem
  4. Patient does not agree to participate in the study
  5. Patients who are pregnant or lactating
  6. Patients whose visceral pain is expected to be too severe
  7. Patients receiving a single laparoscopic cholecystectomy (including using a robot)

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

preoperative Rectus sheath block: group Pre

postoperative Rectus sheath block: group Post

Arm Description

ultrasound guided Rectus sheath block block with 0.25% ropivacaine 40ml Before surgical incision

ultrasound guided Rectus sheath block block with 0.25% ropivacaine 40ml After surgical incision

Outcomes

Primary Outcome Measures

Difference of analgesic consumption between both group
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 Outcome Measures

compare the Numeric rating scale (NRS)
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).

Full Information

First Posted
January 15, 2018
Last Updated
January 21, 2019
Sponsor
Asan Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT03413280
Brief Title
Preemptive Analgesic Effects of Rectus Sheath Block in Laparoscopic Cholecystectomy Patients
Official Title
The Effectiveness of Preemptive Effect of Rectus Sheath Block and Intercostal Block on Postoperative Visceral Pain in Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 28, 2017 (Actual)
Primary Completion Date
August 25, 2017 (Actual)
Study Completion Date
January 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preemptive Peripheral Nerve Block, Pain, Postoperative, Acute Pain
Keywords
preemptive analgic effect, Rectus Sheath Block, laparoscopic cholecystectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
preoperative Rectus sheath block: group Pre
Arm Type
Experimental
Arm Description
ultrasound guided Rectus sheath block block with 0.25% ropivacaine 40ml Before surgical incision
Arm Title
postoperative Rectus sheath block: group Post
Arm Type
Active Comparator
Arm Description
ultrasound guided Rectus sheath block block with 0.25% ropivacaine 40ml After surgical incision
Intervention Type
Drug
Intervention Name(s)
Ultrasound guided Rectus sheath block
Intervention Description
Ultrasound guided rectus sheath block with 0.25% ropivacaine 34ml around umbilicus
Intervention Type
Drug
Intervention Name(s)
Intercostal nerve block
Intervention Description
Ultrasound guided intercostal nerve block with 0.25% ropivacaine 6ml in 7,8,9 th intercostal space
Primary Outcome Measure Information:
Title
Difference of analgesic consumption between both group
Description
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.
Time Frame
at 0, 0.5, 1, 2, 6, 9, 18, 24 hours after operation
Secondary Outcome Measure Information:
Title
compare the Numeric rating scale (NRS)
Description
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).
Time Frame
at 0, 0.5, 1, 2, 6, 9, 18, 24 hours after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JongHyuk Lee, MD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
State/Province
Songpa-gu
ZIP/Postal Code
05505
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Preemptive Analgesic Effects of Rectus Sheath Block in Laparoscopic Cholecystectomy Patients

We'll reach out to this number within 24 hrs