Analgesic Effects of US Bilateral Rectus Sheath Block for Laparoscopic GY Surgery

Gynecologic Disease Clinical Trial

Official title:

Postoperative Analgesic Effects of Ultrasound-guided Bilateral Rectus Sheath Block for Laparoscopic Gynecologic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02476799
• Other study ID #: EUMC 2014-07-006-001
• Status: Completed
• Phase: N/A
• First received: June 17, 2015
• Last updated: June 18, 2015
• Start date: November 2014
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: Ewha Womans University Mokdong Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Rectus sheath block (RSB) is a kind of anterior abdominal wall block. It has postoperative analgesic effect for abdominal surgery with midline incision. Laparoscopic gynecologic surgery is accompanied by significant postoperative pain and usually IV-PCA is used to manage the pain.The purpose of this study is to investigate the analgesic effect of ultrasound-guided RSB to multi-port laparoscopic gynecologic surgery which has incision site at umbilical area. Patients will randomly assigned to two groups, RSB group and Control group. Each patients will assessed for time to first rescue analgesia, verbal numerical rating pain scores, number of rescue analgesic demands, and postoperatively opioids use by IV-PCA by a blinded investigator at 0, 1, 6, 12, 24 and 48 hours postoperatively.

Description:

Patients of RSB group will be performed ultrasound-guided bilateral RSB after induction of general anesthesia. The procedure will be performed bilaterally and 15 ml on each side, total 30 ml of 0.25% ropivacaine will be injected. After the procedure, a surgery scheduled will be proceeded. Patient of Control group will be proceeded the surgery after induction of anesthesia. All patients will use total 100 ml of IV-PCA containing 800 µg of fentanyl with 150 mg of ketorolac for 48 hours postoperatively. If a patient complains pain more intense than VNRS 4 or demands an analgesic drug, a rescue analgesic would be allowed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 60 Years

Eligibility

Inclusion Criteria:

• Multi-port laparoscopic gynecologic surgery

• American society of Anesthesiologists (ASA) physical status classification I-II

• Age: 21-60

Exclusion Criteria:

• Gynecologic cancer operation

• History of previous abdominal surgery

• Allergy to local anesthetics(ropivacaine)

• Opioid tolerance

• Coagulopathy

• Infection at the needle insertion site

• Difficulty to cooperating

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Genital Diseases, Female
• Gynecologic Disease

Intervention

Procedure:
• Rectus sheath block
Ultrasound-guided bilateral rectus sheath block of RSB group using 0.25% Ropivacaine

Drug:
• Ropivacaine
Ultrasound-guided bilateral rectus sheath block of RSB group using 0.25% Ropivacaine

Other:
• Bandage
After the surgery, a bandage will be attached on injection site where is same as the incision site of surgery.

Drug:
• IV-PCA containing Fentanyl and Ketorolac
All patients will use total 100 ml of IV-PCA containing 800 µg of fentanyl and 150 mg of ketorolac for 48 hours postoperatively.

Locations

Country	Name	City	State
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Ewha Womans University Mokdong Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of rescue analgesics	Number of injected additional NSAIDs other than IV-PCA for 48 hours postoperatively	48 hours postoperatively	No
Secondary	Total opioids use	Total dosage of injected fentanyl through IV-PCA	Time Frame: 0, 1, 6, 12, 24, 48 hours postoperatively	No
Secondary	Time to first rescue analgesic request	How long it takes postoperative time to first additional analgesic drug injection by patient's request	48 hours postoperatively	No
Secondary	Postoperative pain measured on the verbal numerical rating scale	Postoperative pain on each time point which is expressed by verbal numerical rating scale (0 ~ 10)	0, 1, 6, 12, 24, 48 hours postoperatively	No