NCT03413280

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 29, 2018

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

5 months

First QC Date

January 15, 2018

Last Update Submit

January 21, 2019

Conditions

Preemptive Peripheral Nerve BlockPain, PostoperativeAcute Pain

Keywords

preemptive analgic effectRectus Sheath Blocklaparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (1)

  • 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.

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

Secondary Outcomes (1)

  • compare the Numeric rating scale (NRS)

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

Study Arms (2)

preoperative Rectus sheath block: group Pre

EXPERIMENTAL

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

Drug: Ultrasound guided Rectus sheath blockDrug: Intercostal nerve block

postoperative Rectus sheath block: group Post

ACTIVE COMPARATOR

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

Drug: Ultrasound guided Rectus sheath blockDrug: Intercostal nerve block

Interventions

Ultrasound guided Rectus sheath blockDRUG

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

postoperative Rectus sheath block: group Postpreoperative Rectus sheath block: group Pre
Intercostal nerve blockDRUG

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

postoperative Rectus sheath block: group Postpreoperative Rectus sheath block: group Pre

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, Songpa-gu, 05505, South Korea

Location

MeSH Terms

Conditions

Pain, PostoperativeAcute Pain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • JongHyuk Lee, MD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical assistant professor

Study Record Dates

First Submitted

January 15, 2018

First Posted

January 29, 2018

Study Start

March 28, 2017

Primary Completion

August 25, 2017

Study Completion

January 15, 2018

Last Updated

January 23, 2019

Record last verified: 2019-01

Locations

KR(1)