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

Not Applicable

Completed

• Conditions: Visceral Pain, Postoperative
• Interventions: Drug: Ultrasound guided Rectus sheath block; Drug: Ultrasound erector spinae plane block

• Registration Number: NCT03767816
• Lead Sponsor: Asan Medical Center

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-15
• Study First Submitted QC: 2018-12-05
• Study First Posted: 2018-12-07
• Study Start: 2018-12-17
• Primary Completion: 2019-03-30
• Study Completion: 2019-06-30
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-01
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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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 with deformity at vertebra or chest wall.
6. Patients who are pregnant or lactating
7. Patients receiving a single laparoscopic cholecystectomy (including using a robot)
8. Patients with severe intraperitoneal adhesion (higher than Nair s grade 3), or with external drain.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group RE: Rectus sheath block and erector spinae plane block	Ultrasound 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
Group RE: Rectus sheath block and erector spinae plane block	Ultrasound guided Rectus sheath 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
Group R : Rectus sheath block group	Ultrasound guided Rectus sheath block	ultrasound guided Rectus sheath block with 0.2% ropivacaine (Fresenius Kabi) 30ml before surgical incision

Primary Outcome Measures

Name	Time	Method
Difference of analgesic consumption between both group	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 Outcome Measures

Name	Time	Method
compare the Numeric rating scale (NRS)	at 0, 0.5, 1, 2, 6, 9, 18, 24 hours after operation	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, 12, 18, 24 hours postoperatively).

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Songpa-gu, Korea, Republic of