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

Postoperative Analgesic Effects of Ultrasound-guided Bilateral Rectus Sheath Block for Robotic Single-port Gynecologic Surgery

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.

Study Overview

• Status: Completed
• Conditions: Gynecologic Disease
• Intervention / Treatment: Procedure: Rectus sheath block; Drug: Ropivacaine; Other: Bandage; Drug: IV-PCA containing Fentanyl

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 158-710
    • Ewha Womans University MokDong Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Rectus sheath block; Ultrasound-guided bilateral rectus sheath block of RSB group using 0.25% Ropivacaine; Other Names: RSB; Drug: Ropivacaine; Ultrasound-guided bilateral rectus sheath block of RSB group using 0.25% Ropivacaine; Other Names: Naropin; Other: Bandage; After the surgery, a bandage will be attached on injection site where is same as the incision site of surgery.; Drug: IV-PCA containing Fentanyl; All patients will use total 100 ml of IV-PCA containing 800 µg of fentanyl for 48 hours postoperatively.; Other Names: Intravenous patient controlled analgesia using fentanyl
Sham Comparator: 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.	Other: Bandage; After the surgery, a bandage will be attached on injection site where is same as the incision site of surgery.; Drug: IV-PCA containing Fentanyl; All patients will use total 100 ml of IV-PCA containing 800 µg of fentanyl for 48 hours postoperatively.; Other Names: Intravenous patient controlled analgesia using fentanyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Verbal numerical rating scale	Postoperative pain on each time point which is expressed by verbal numerical rating scale (0 ~ 10)	6 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Total opioids use	Total dosage of injected fentanyl through IV-PCA	0, 1, 6, 12, 24, 48 hours postoperatively
Verbal numerical rating scale	Postoperative pain on each time point which is expressed by verbal numerical rating scale (0 ~ 10)	0, 1, 12, 24, 48 hours postoperatively

Collaborators and Investigators

• Sponsor: Ewha Womans University Mokdong Hospital
• Investigators: Principal Investigator: Youn Jin Kim, MD, PhD, Ewha Womans University MokDong Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): January 31, 2017
• Study Completion (Actual): January 31, 2017

Study Registration Dates

• First Submitted: May 8, 2015
• First Submitted That Met QC Criteria: May 18, 2015
• First Posted (Estimate): May 21, 2015

Study Record Updates

• Last Update Posted (Estimate): February 8, 2017
• Last Update Submitted That Met QC Criteria: February 6, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Fentanyl; Ropivacaine
• Other Study ID Numbers: EUMC 2015-01-024-002