Gynecologic Disease
Conditions
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.
Interventions
PROCEDURERectus sheath block
Ultrasound-guided bilateral rectus sheath block of RSB group using 0.25% Ropivacaine
DRUGRopivacaine
Ultrasound-guided bilateral rectus sheath block of RSB group using 0.25% Ropivacaine
OTHERBandage
After the surgery, a bandage will be attached on injection site where is same as the incision site of surgery.
DRUGIV-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.
Sponsors
Ewha Womans University Mokdong Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of rescue analgesics | 48 hours postoperatively | Number of injected additional NSAIDs other than IV-PCA for 48 hours postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total opioids use | Time Frame: 0, 1, 6, 12, 24, 48 hours postoperatively | Total dosage of injected fentanyl through IV-PCA |
| Time to first rescue analgesic request | 48 hours postoperatively | How long it takes postoperative time to first additional analgesic drug injection by patient's request |
| Postoperative pain measured on the verbal numerical rating scale | 0, 1, 6, 12, 24, 48 hours postoperatively | Postoperative pain on each time point which is expressed by verbal numerical rating scale (0 \ 10) |
Countries
South Korea
Outcome results
None listed