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Clinical Trials/NCT03767816
NCT03767816
Completed
Not Applicable

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

Asan Medical Center1 site in 1 country60 target enrollmentDecember 17, 2018

Overview

Phase
Not Applicable
Intervention
Ultrasound guided Rectus sheath block
Conditions
Visceral Pain, Postoperative
Sponsor
Asan Medical Center
Enrollment
60
Locations
1
Primary Endpoint
Difference of analgesic consumption between both group
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
December 17, 2018
End Date
June 30, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jong Hyuk Lee

clinical assistant professor

Asan Medical Center

Eligibility Criteria

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.

Arms & Interventions

Group R : Rectus sheath block group

ultrasound guided Rectus sheath block with 0.2% ropivacaine (Fresenius Kabi) 30ml before surgical incision

Intervention: Ultrasound guided Rectus sheath block

Group RE: Rectus sheath block and erector spinae plane block

ultrasound guided Rectus sheath block with 0.2% ropivacaine (Fresenius Kabi) 30ml before surgical incision and ultrasound guided erector spinae plane block with 0.2% ropivacaine (Fresenius Kabi) 40ml

Intervention: Ultrasound guided Rectus sheath block

Group RE: Rectus sheath block and erector spinae plane block

ultrasound guided Rectus sheath block with 0.2% ropivacaine (Fresenius Kabi) 30ml before surgical incision and ultrasound guided erector spinae plane block with 0.2% ropivacaine (Fresenius Kabi) 40ml

Intervention: Ultrasound erector spinae plane block

Outcomes

Primary Outcomes

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

  • compare the Numeric rating scale (NRS)(at 0, 0.5, 1, 2, 6, 9, 18, 24 hours after operation)

Study Sites (1)

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