Clinical Trials Directory

Trials / Completed

CompletedNCT02450084

Ultrasound-guided Bilateral Rectus Sheath Block for Robotic Single-port Gynecologic Surgery

Postoperative Analgesic Effects of Ultrasound-guided Bilateral Rectus Sheath Block for Robotic Single-port Gynecologic Surgery

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Ewha Womans University Mokdong Hospital · Academic / Other
Sex
Female
Age
21 Years – 60 Years
Healthy volunteers
Not accepted

Summary

Rectus sheath block (RSB) is a kind of anterior abdominal wall block. It has postoperative analgesic effect for abdominal surgery with midline incision. Robotic 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 single-port robotic 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 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.

Conditions

Interventions

TypeNameDescription
PROCEDURERectus sheath blockUltrasound-guided bilateral rectus sheath block of RSB group using 0.25% Ropivacaine
DRUGRopivacaineUltrasound-guided bilateral rectus sheath block of RSB group using 0.25% Ropivacaine
OTHERBandageAfter the surgery, a bandage will be attached on injection site where is same as the incision site of surgery.
DRUGIV-PCA containing FentanylAll patients will use total 100 ml of IV-PCA containing 800 µg of fentanyl for 48 hours postoperatively.

Timeline

Start date
2015-05-01
Primary completion
2017-01-31
Completion
2017-01-31
First posted
2015-05-21
Last updated
2017-02-08

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT02450084. Inclusion in this directory is not an endorsement.