Preemptive Analgesic Effects of Rectus Sheath Block in Laparoscopic Cholecystectomy Patients

Not Applicable

Completed

• Conditions: Preemptive Peripheral Nerve Block; Pain, Postoperative; Acute Pain
• Interventions: Drug: Ultrasound guided Rectus sheath block; Drug: Intercostal nerve block

• Registration Number: NCT03413280
• Lead Sponsor: Asan Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-28
• Primary Completion: 2017-08-25
• Study Completion: 2018-01-15
• Study First Submitted: 2018-01-15
• Study First Submitted QC: 2018-01-22
• Study First Posted: 2018-01-29
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-21
• Last Update Posted: 2019-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

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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 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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
postoperative Rectus sheath block: group Post	Intercostal nerve block	ultrasound guided Rectus sheath block block with 0.25% ropivacaine 40ml After surgical incision
postoperative Rectus sheath block: group Post	Ultrasound guided Rectus sheath block	ultrasound guided Rectus sheath block block with 0.25% ropivacaine 40ml After surgical incision
preoperative Rectus sheath block: group Pre	Ultrasound guided Rectus sheath block	ultrasound guided Rectus sheath block block with 0.25% ropivacaine 40ml Before surgical incision
preoperative Rectus sheath block: group Pre	Intercostal nerve block	ultrasound guided Rectus sheath block block with 0.25% ropivacaine 40ml Before surgical incision

Primary Outcome Measures

Name	Time	Method
Difference of analgesic consumption between both group	at 0, 0.5, 1, 2, 6, 9, 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, 9, 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	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).

Trial Locations

Locations (1)

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