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

Sponsors

Lead Sponsor: Ewha Womans University Mokdong Hospital

Source Ewha Womans University Mokdong Hospital
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.

Overall Status Completed
Start Date May 2015
Completion Date January 31, 2017
Primary Completion Date January 31, 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Verbal numerical rating scale 6 hours postoperatively
Secondary Outcome
Measure Time Frame
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
Enrollment 60
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Rectus sheath block

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

Arm Group Label: Rectus sheath block

Other Name: RSB

Intervention Type: Drug

Intervention Name: Ropivacaine

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

Arm Group Label: Rectus sheath block

Other Name: Naropin

Intervention Type: Other

Intervention Name: Bandage

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

Intervention Type: Drug

Intervention Name: IV-PCA containing Fentanyl

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

Other Name: 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

Gender: Female

Minimum Age: 21 Years

Maximum Age: 60 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Youn Jin Kim, MD, PhD Principal Investigator Ewha Womans University Mokdong Hospital
Location
Facility: Ewha Womans University Mokdong Hospital
Location Countries

Korea, Republic of

Verification Date

February 2017

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Ewha Womans University Mokdong Hospital

Investigator Full Name: Youn Jin Kim

Investigator Title: Associate Professor of Anesthesiology and Pain Medicine

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Rectus sheath block

Type: Experimental

Description: 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.

Label: Control

Type: Sham Comparator

Description: 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.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Source: ClinicalTrials.gov