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

Ewha Womans University

Status: Completed

Conditions: Gynecologic Disease

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02450084

EUMC 2015-01-024-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 21 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Rectus sheath block

Experimental group

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.

Treatment:

Procedure: Rectus sheath block

Other: Bandage

Drug: IV-PCA containing Fentanyl

Drug: Ropivacaine

Control

Sham Comparator group

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.

Treatment:

Other: Bandage

Drug: IV-PCA containing Fentanyl