Comparison of Quadratus Lumborum Intramuscular and Transmuscular in Postoperative Pain
Primary Purpose
Pain, Postoperative, Pain, Acute, Cesarean Section Complications
Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Quadratus lumborum block after C-section surgery as postoperative pain management
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
Eligibility Criteria
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.
Sites / Locations
- Sanglah General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Quadratus lumborum intramuscular block
Quadratus lumborum transmucular block
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Postoperative pain
Postoperative pain intensity measured by Visual Analog Scale (VAS), 0=no pain, 100=worst pain
Postoperative morphine requirements
Total delivered morphine dose after surgery to alleviate postoperative pain (measured by total delivered dose recorded on the Patient-Controlled Analgesia tool)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05005871
Brief Title
Comparison of Quadratus Lumborum Intramuscular and Transmuscular in Postoperative Pain
Official Title
Comparison of the Effectiveness of Intramuscular and Transmucular Quadratus Lumborum Blocks Quality in Postoperative Pain
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
October 14, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Udayana University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Pain, Acute, Cesarean Section Complications
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Quadratus lumborum intramuscular block
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Quadratus lumborum transmucular block
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Quadratus lumborum block after C-section surgery as postoperative pain management
Intervention Description
To manage postoperative pain, the subjects will be allocated to either QLB or QLTB group to receive the respective intervention.
Primary Outcome Measure Information:
Title
Postoperative pain
Description
Postoperative pain intensity measured by Visual Analog Scale (VAS), 0=no pain, 100=worst pain
Time Frame
Up to 24 hours after surgery
Title
Postoperative morphine requirements
Description
Total delivered morphine dose after surgery to alleviate postoperative pain (measured by total delivered dose recorded on the Patient-Controlled Analgesia tool)
Time Frame
Up to 72 hours after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Sanglah General Hospital
City
Denpasar
State/Province
Bali
ZIP/Postal Code
80114
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Comparison of Quadratus Lumborum Intramuscular and Transmuscular in Postoperative Pain
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