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NCT Number: NCT02476799

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

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.

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Key information

Conditions

Gynecologic Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

21 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ewha Womans University Mokdong Hospital

Seoul, 158710, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rectus sheath block

Procedure

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

Other names: RSB

Ropivacaine

Drug

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

Other names: Naropin

Bandage

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 and Ketorolac

Drug

All patients will use total 100 ml of IV-PCA containing 800 µg of fentanyl and 150 mg of ketorolac for 48 hours postoperatively.

Other names: Intravenous patient controlled analgesia

Primary outcomes

  1. Number of rescue analgesics

    Time frame: 48 hours postoperatively

    Number of injected additional NSAIDs other than IV-PCA for 48 hours postoperatively

Secondary outcomes

  1. Total opioids use

    Time frame: Time Frame: 0, 1, 6, 12, 24, 48 hours postoperatively

    Total dosage of injected fentanyl through IV-PCA

  2. Time to first rescue analgesic request

    Time frame: 48 hours postoperatively

    How long it takes postoperative time to first additional analgesic drug injection by patient's request

  3. Postoperative pain measured on the verbal numerical rating scale

    Time frame: 0, 1, 6, 12, 24, 48 hours postoperatively

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

Sponsors and collaborators

Lead sponsor

Ewha Womans University Mokdong Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 19, 2015
Registry last updated
Jun 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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