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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gynecologic Disease

Intervention / Treatment
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* Procedure: Rectus sheath block
* Drug: Ropivacaine
* Other: Bandage
* Drug: IV-PCA containing Fentanyl and Ketorolac


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rectus sheath block<br>Patients of RSB group will be performed ultrasound-guided bilateral RSB after induction of general anesthesia. After draping the needle insertion site, a 22-gauge, 50-mm needle will be inserted medial to the probe by the in-plane technique and advanced in a lateral direction on just lateral to umbilicus. 15 ml of 0.25% ropivacaine will be injected on the posterior border of rectus muscle. This procedure will be performed bilaterally and total 30 ml of 0.25% ropivacaine will be injected. After the surgery, a bandage will be attached on injection site where is same as the incision site of surgery. All patients will use total 100 ml of IV-PCA containing fentanyl and ketorolac for 48 hours postoperatively. | Procedure: Rectus sheath block<br>* Ultrasound-guided bilateral rectus sheath block of RSB group using 0.25% Ropivacaine<br>* Other names: RSB;Drug: Ropivacaine<br>* Ultrasound-guided bilateral rectus sheath block of RSB group using 0.25% Ropivacaine<br>* Other names: Naropin;Other: Bandage<br>* After the surgery, a bandage will be attached on injection site where is same as the incision site of surgery.<br>Drug: IV-PCA containing Fentanyl and Ketorolac<br>* All patients will use total 100 ml of IV-PCA containing 800 µg of fentanyl and 150 mg of ketorolac for 48 hours postoperatively.<br>* Other names: Intravenous patient controlled analgesia;|
| Sham Comparator: Control<br>Patients of Control group will be proceeded a surgery scheduled after induction of general anesthesia without any procedure such as placebo injection. After the surgery, a bandage will be attached on the incision site where is same as the block injection site of RSB group. All patients will use total 100 ml of IV-PCA containing fentanyl and ketorolac for 48 hours postoperatively. | Other: Bandage<br>* After the surgery, a bandage will be attached on injection site where is same as the incision site of surgery.<br>Drug: IV-PCA containing Fentanyl and Ketorolac<br>* All patients will use total 100 ml of IV-PCA containing 800 µg of fentanyl and 150 mg of ketorolac for 48 hours postoperatively.<br>* Other names: Intravenous patient controlled analgesia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of rescue analgesics | Number of injected additional NSAIDs other than IV-PCA for 48 hours postoperatively | 48 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total opioids use | Total dosage of injected fentanyl through IV-PCA | Time Frame: 0, 1, 6, 12, 24, 48 hours postoperatively | 
| 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 | 
| 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 |