Preemptive Analgesic Effects of Rectus Sheath Block in Laparoscopic Cholecystectomy Patients

Pain, Postoperative Clinical Trial

Official title:

The Effectiveness of Preemptive Effect of Rectus Sheath Block and Intercostal Block on Postoperative Visceral Pain in Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03413280
• Other study ID #: 2017-0301
• Status: Completed
• Phase: N/A
• Start date: March 28, 2017
• Est. completion date: January 15, 2018

Study information

• Verified date: January 2019
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 15, 2018
• Est. primary completion date: August 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acute Pain
• Pain, Postoperative
• Preemptive Peripheral Nerve Block

Intervention

Drug:
• Ultrasound guided Rectus sheath block
Ultrasound guided rectus sheath block with 0.25% ropivacaine 34ml around umbilicus
• Intercostal nerve block
Ultrasound guided intercostal nerve block with 0.25% ropivacaine 6ml in 7,8,9 th intercostal space

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul	Songpa-gu

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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, 9, 18, 24 hours after operation) to compare.	at 0, 0.5, 1, 2, 6, 9, 18, 24 hours after operation
Secondary	compare the Numeric rating scale (NRS)	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).	at 0, 0.5, 1, 2, 6, 9, 18, 24 hours after operation