- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02476799
Analgesic Effects of US Bilateral Rectus Sheath Block for Laparoscopic GY Surgery
June 18, 2015 updated by: Youn Jin Kim, Ewha Womans University Mokdong Hospital
Postoperative Analgesic Effects of Ultrasound-guided Bilateral Rectus Sheath Block for Laparoscopic 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.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Seoul, Korea, Republic of, 158710
- Ewha Womans University Mokdong Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
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 and ketorolac for 48 hours postoperatively.
|
Ultrasound-guided bilateral rectus sheath block of RSB group using 0.25% Ropivacaine
Other Names:
Ultrasound-guided bilateral rectus sheath block of RSB group using 0.25% Ropivacaine
Other Names:
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 800 µg of fentanyl and 150 mg of ketorolac for 48 hours postoperatively.
Other Names:
|
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.
|
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 800 µg of fentanyl and 150 mg of ketorolac for 48 hours postoperatively.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of rescue analgesics
Time Frame: 48 hours postoperatively
|
Number of injected additional NSAIDs other than IV-PCA for 48 hours postoperatively
|
48 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total opioids use
Time Frame: Time Frame: 0, 1, 6, 12, 24, 48 hours postoperatively
|
Total dosage of injected fentanyl through IV-PCA
|
Time Frame: 0, 1, 6, 12, 24, 48 hours postoperatively
|
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
|
48 hours postoperatively
|
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)
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0, 1, 6, 12, 24, 48 hours postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Youn Jin Kim, MD, PhD, Ewha Womans University Mokdong Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2014
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
June 17, 2015
First Submitted That Met QC Criteria
June 18, 2015
First Posted (Estimate)
June 19, 2015
Study Record Updates
Last Update Posted (Estimate)
June 19, 2015
Last Update Submitted That Met QC Criteria
June 18, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Anesthetics, Local
- Fentanyl
- Ketorolac
- Ropivacaine
Other Study ID Numbers
- EUMC 2014-07-006-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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