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

Sponsor

Ewha Womans University Mokdong Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02476799

Collaborator

(none)

Enrollment

Location

Arms

5.9

Duration (Months)

10.1

Patients Per Site Per Month

Study Details

Study Description

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. 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.

Condition or Disease	Intervention/Treatment	Phase
Gynecologic Disease	Procedure: Rectus sheath block Drug: Ropivacaine Other: Bandage Drug: IV-PCA containing Fentanyl and Ketorolac	N/A

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 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2014

Actual Primary Completion Date :

May 1, 2015

Actual Study Completion Date :

May 1, 2015

Arms and Interventions

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 and ketorolac 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 and Ketorolac 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
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 and ketorolac 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 and Ketorolac 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

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 and ketorolac 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 and Ketorolac

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

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 and ketorolac 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 and Ketorolac

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

Outcome Measures

Primary Outcome Measures

Number of rescue analgesics [48 hours postoperatively]
Number of injected additional NSAIDs other than IV-PCA for 48 hours postoperatively

Secondary Outcome Measures

Total opioids use [Time Frame: 0, 1, 6, 12, 24, 48 hours postoperatively]
Total dosage of injected fentanyl through IV-PCA
Time to first rescue analgesic request [48 hours postoperatively]
How long it takes postoperative time to first additional analgesic drug injection by patient's request
Postoperative pain measured on the verbal numerical rating scale [0, 1, 6, 12, 24, 48 hours postoperatively]
Postoperative pain on each time point which is expressed by verbal numerical rating scale (0 ~ 10)

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ewha Womans University Mokdong Hospital	Seoul		Korea, Republic of	158710

Sponsors and Collaborators

Ewha Womans University Mokdong Hospital

Investigators

Principal Investigator: Youn Jin Kim, MD, PhD, Ewha Womans University Mokdong Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Youn Jin Kim, Associate Professor of Anesthesiology and Pain Medicine, Ewha Womans University Mokdong Hospital

ClinicalTrials.gov Identifier:

NCT02476799

Other Study ID Numbers:

EUMC 2014-07-006-001

First Posted:

Jun 19, 2015

Last Update Posted:

Jun 19, 2015

Last Verified:

Jun 1, 2015

Additional relevant MeSH terms:

Ketorolac

Fentanyl

Ropivacaine

Study Results

No Results Posted as of Jun 19, 2015