Clinical trial NCT02476799: Analgesic Effects of US Bilateral Rectus Sheath Block for Laparoscopic GY Surgery
Official title: Postoperative Analgesic Effects of Ultrasound-guided Bilateral Rectus Sheath Block for Laparoscopic Gynecologic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Disease
Lead sponsor: Ewha Womans University Mokdong Hospital
Sponsor class: OTHER
First posted: 2015-06-19
Enrollment: 60
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of rescue analgesics
timeFrame: 48 hours postoperatively
Secondary outcomes:
measure: Total opioids use
timeFrame: Time Frame: 0, 1, 6, 12, 24, 48 hours postoperatively
measure: Time to first rescue analgesic request
timeFrame: 48 hours postoperatively
measure: Postoperative pain measured on the verbal numerical rating scale
timeFrame: 0, 1, 6, 12, 24, 48 hours postoperatively
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
Study officials:
affiliation: Ewha Womans University Mokdong Hospital
name: Youn Jin Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cho S, Kim YJ, Jeong K, Moon HS. Ultrasound-guided bilateral rectus sheath block reduces early postoperative pain after laparoscopic gynecologic surgery: a randomized study. J Anesth. 2018 Apr;32(2):189-197. doi: 10.1007/s00540-018-2457-0. Epub 2018 Feb 8.