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

NCT ID: NCT02450084

Last Updated: 2017-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2017-01-31

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. 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

Gynecologic Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Rectus sheath block

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 800 µg for 48 hours postoperatively.

Group Type: EXPERIMENTAL

Rectus sheath block

Intervention Type: PROCEDURE

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

Ropivacaine

Intervention Type: DRUG

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

Bandage

Intervention Type: OTHER

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

IV-PCA containing Fentanyl

Intervention Type: DRUG

All patients will use total 100 ml of IV-PCA containing 800 µg of fentanyl for 48 hours postoperatively.

Control

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 800µg for 48 hours postoperatively.

Group Type: SHAM_COMPARATOR

Bandage

Intervention Type: OTHER

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

IV-PCA containing Fentanyl

Intervention Type: DRUG

All patients will use total 100 ml of IV-PCA containing 800 µg of fentanyl for 48 hours postoperatively.

Interventions

Rectus sheath block

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

Intervention Type: PROCEDURE

Ropivacaine

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

Intervention Type: DRUG

Bandage

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

Intervention Type: OTHER

IV-PCA containing Fentanyl

All patients will use total 100 ml of IV-PCA containing 800 µg of fentanyl for 48 hours postoperatively.

Intervention Type: DRUG

Other Intervention Names

RSB; Naropin; Intravenous patient controlled analgesia using fentanyl

Eligibility Criteria

Inclusion Criteria

• Robotic single-port 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ewha Womans University Mokdong Hospital

OTHER

Sponsor Role: lead

Responsible Party

Youn Jin Kim

Associate Professor of Anesthesiology and Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Youn Jin Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ewha Womans University Mokdong Hospital

Locations

Ewha Womans University Mokdong Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

EUMC 2015-01-024-002

Identifier Type: -

Identifier Source: org_study_id