- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05005871
Comparison of Quadratus Lumborum Intramuscular and Transmuscular in Postoperative Pain
Comparison of the Effectiveness of Intramuscular and Transmucular Quadratus Lumborum Blocks Quality in Postoperative Pain
Acute pain is reported in approximately 80% of patients undergoing postoperative care for various types of surgical procedures in the United States. Another study reported patient postoperative pain intensity with 75% with severe pain in the first 1 to 2 postoperative days and 38% reporting moderate to severe pain at 14 postoperative days. Several modalities have been used as the standard for the management of pain postoperative C-sections.
One of the postoperative analgesic modalities for SC is quadratus lumborum block (QLB). This technique has advantages in relieving postoperative pain after C-section because it is considered to be able to relieve visceral pain as well as somatic pain. The transmuscular QLB (QLBT) approach is one of the most frequently used. This technique was found to be effective with regard to the distribution of analgesics to the paravertebral spaces which is the hallmark of QLB. However, this technique was found to be difficult to perform. Difficulties were reported related to the position of the procedure i.e. lateral or sitting position.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bali
-
Denpasar, Bali, Indonesia, 80114
- Sanglah General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Underwent C-section with subarachnoid block
- Aged 18-35 years old.
- ASA preoperative physical status 1-2
Exclusion Criteria:
- Coagulopathy
- Anatomic abnormalities of the abdomen
- History of allergy to local anesthesia
- History of hyperalgesia
- History of drug abuse (sedatives, opioids, paracetamol, or other pain relievers)
- Require postoperative intensive care
- Refuse to participate in research.
Study Plan
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 |
---|---|
Active Comparator: Quadratus lumborum intramuscular block
The quadratus lumborum intramuscular block will be performed immediately at the end of the surgery.
Administration of 0.4 mL of 0.25% bupivacaine will be carried out under ultrasound guidance and performed by experienced anesthesiologists.
|
To manage postoperative pain, the subjects will be allocated to either QLB or QLTB group to receive the respective intervention.
|
Active Comparator: Quadratus lumborum transmucular block
The quadratus lumborum transmuscular block will be performed immediately at the end of the surgery.
Administration of 0.4 mL of 0.25% bupivacaine will be carried out under ultrasound guidance and performed by experienced anesthesiologists.
|
To manage postoperative pain, the subjects will be allocated to either QLB or QLTB group to receive the respective intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative pain
Time Frame: Up to 24 hours after surgery
|
Postoperative pain intensity measured by Visual Analog Scale (VAS), 0=no pain, 100=worst pain
|
Up to 24 hours after surgery
|
Postoperative morphine requirements
Time Frame: Up to 72 hours after surgery
|
Total delivered morphine dose after surgery to alleviate postoperative pain (measured by total delivered dose recorded on the Patient-Controlled Analgesia tool)
|
Up to 72 hours after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UNUD-CTR-FK150621-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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