Preemptive Analgesic Effects of Rectus Sheath Block in Laparoscopic Cholecystectomy Patients

• Sponsor: Asan Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03413280
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Actual Duration (Months): 9.6
• Patients Per Site Per Month: 20.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Preemptive Peripheral Nerve Block; Pain, Postoperative; Acute Pain	Drug: Ultrasound guided Rectus sheath block; Drug: Intercostal nerve block	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: The Effectiveness of Preemptive Effect of Rectus Sheath Block and Intercostal Block on Postoperative Visceral Pain in Laparoscopic Cholecystectomy
• Actual Study Start Date: Mar 28, 2017
• Actual Primary Completion Date: Aug 25, 2017
• Actual Study Completion Date: Jan 15, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: preoperative Rectus sheath block: group Pre ultrasound guided Rectus sheath block block with 0.25% ropivacaine 40ml Before surgical incision	Drug: Ultrasound guided Rectus sheath block; Ultrasound guided rectus sheath block with 0.25% ropivacaine 34ml around umbilicus; Drug: Intercostal nerve block; Ultrasound guided intercostal nerve block with 0.25% ropivacaine 6ml in 7,8,9 th intercostal space
Active Comparator: postoperative Rectus sheath block: group Post ultrasound guided Rectus sheath block block with 0.25% ropivacaine 40ml After surgical incision	Drug: Ultrasound guided Rectus sheath block; Ultrasound guided rectus sheath block with 0.25% ropivacaine 34ml around umbilicus; Drug: Intercostal nerve block; Ultrasound guided intercostal nerve block with 0.25% ropivacaine 6ml in 7,8,9 th intercostal space

Outcome Measures

Primary Outcome Measures

1. 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

1. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan Medical Center	Seoul	Songpa-gu	Korea, Republic of	05505

Sponsors and Collaborators

• Asan Medical Center

Investigators

• Principal Investigator: JongHyuk Lee, MD, Asan Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jong Hyuk Lee, clinical assistant professor, Asan Medical Center
• ClinicalTrials.gov Identifier: NCT03413280
• Other Study ID Numbers: 2017-0301
• First Posted: Jan 29, 2018
• Last Update Posted: Jan 23, 2019
• Last Verified: Jan 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jong Hyuk Lee, clinical assistant professor, Asan Medical Center: preemptive analgic effect; Rectus Sheath Block; laparoscopic cholecystectomy
• Additional relevant MeSH terms: Pain, Postoperative; Acute Pain

Study Results

No Results Posted as of Jan 23, 2019