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

NCT02450084 | Completed

• 1 other identifier: EUMC 2015-01-024-002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Disease

Outcome Measures

Primary Outcomes (1)

• Verbal numerical rating scale

  Postoperative pain on each time point which is expressed by verbal numerical rating scale (0 \~ 10)

  6 hours postoperatively

Secondary Outcomes (3)

• Total opioids use

  0, 1, 6, 12, 24, 48 hours postoperatively

• Time to first rescue analgesic request

  48 hours postoperatively

• Verbal numerical rating scale

  0, 1, 12, 24, 48 hours postoperatively

Study Arms (2)

Rectus sheath block

EXPERIMENTAL

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.

Procedure: Rectus sheath block; Drug: Ropivacaine; Other: Bandage; Drug: IV-PCA containing Fentanyl

Control

SHAM COMPARATOR

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.

Other: Bandage; Drug: IV-PCA containing Fentanyl

Interventions

Rectus sheath block PROCEDURE

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

Also known as: RSB

Rectus sheath block

Ropivacaine DRUG

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

Also known as: Naropin

Rectus sheath block

Bandage OTHER

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

Control; Rectus sheath block

IV-PCA containing Fentanyl DRUG

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

Also known as: Intravenous patient controlled analgesia using fentanyl

Control; Rectus sheath block

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Robotic single-port gynecologic surgery
• American society of Anesthesiologists (ASA) physical status classification I-II
• Age: 21-60

You may not qualify if:

• 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

Sponsors & Collaborators

• Ewha Womans University Mokdong Hospital: lead

Study Sites (1)

Ewha Womans University Mokdong Hospital

Seoul, 158-710, South Korea

Location

MeSH Terms

Conditions

Genital Diseases, Female

Interventions

Ropivacaine; Bandages

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Equipment and Supplies

Study Officials

• Youn Jin Kim, MD, PhD

  Ewha Womans University Mokdong Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology and Pain Medicine

Study Record Dates

• First Submitted: May 8, 2015
• First Posted: May 21, 2015
• Study Start: May 1, 2015
• Primary Completion: January 31, 2017
• Study Completion: January 31, 2017
• Last Updated: February 8, 2017

Record last verified: 2017-02

Locations

KR (1)