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

NCT03767816 | Completed

• 1 other identifier: 2018-1320
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Visceral Pain, Postoperative

Keywords

laparoscopic cholecystectomy; erector spinae plane block; visceral pain

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, 12, 18, 24 hours after operation) to compare.

  at 0, 0.5, 1, 2, 6, 12, 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)

Group R : Rectus sheath block group

EXPERIMENTAL

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

Drug: Ultrasound guided Rectus sheath block

Group RE: Rectus sheath block and erector spinae plane block

ACTIVE COMPARATOR

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

Drug: Ultrasound guided Rectus sheath block; Drug: Ultrasound erector spinae plane block

Interventions

Ultrasound guided Rectus sheath block DRUG

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

Group R : Rectus sheath block group; Group RE: Rectus sheath block and erector spinae plane block

Ultrasound erector spinae plane block DRUG

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

Group RE: Rectus sheath block and erector spinae plane block

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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 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.

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, Songpa-gu, 05505, South Korea

Location

MeSH Terms

Conditions

Visceral Pain

Condition Hierarchy (Ancestors)

Nociceptive Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs 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: November 15, 2018
• First Posted: December 7, 2018
• Study Start: December 17, 2018
• Primary Completion: March 30, 2019
• Study Completion: June 30, 2019
• Last Updated: July 5, 2019

Record last verified: 2019-07

Locations

KR (1)