Comparison of Quadratus Lumborum Intramuscular and Transmuscular in Postoperative Pain

Sponsor

Udayana University (Other)

Overall Status

Completed

CT.gov ID

NCT05005871

Collaborator

(none)

Enrollment

Location

Arms

1.4

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative Pain, Acute Cesarean Section Complications	Other: Quadratus lumborum block after C-section surgery as postoperative pain management	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Comparison of the Effectiveness of Intramuscular and Transmucular Quadratus Lumborum Blocks Quality in Postoperative Pain

Actual Study Start Date :

Sep 1, 2021

Actual Primary Completion Date :

Sep 30, 2021

Actual Study Completion Date :

Oct 14, 2021

Arms and Interventions

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.	Other: Quadratus lumborum block after C-section surgery as postoperative pain management 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.	Other: Quadratus lumborum block after C-section surgery as postoperative pain management To manage postoperative pain, the subjects will be allocated to either QLB or QLTB group to receive the respective intervention.

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.

Other: Quadratus lumborum block after C-section surgery as postoperative pain management

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.

Other: Quadratus lumborum block after C-section surgery as postoperative pain management

To manage postoperative pain, the subjects will be allocated to either QLB or QLTB group to receive the respective intervention.

Outcome Measures

Primary Outcome Measures

Postoperative pain [Up to 24 hours after surgery]
Postoperative pain intensity measured by Visual Analog Scale (VAS), 0=no pain, 100=worst pain
Postoperative morphine requirements [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanglah General Hospital	Denpasar	Bali	Indonesia	80114

Sponsors and Collaborators

Udayana University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Christopher Ryalino, MD, Principal Investigator, Udayana University

ClinicalTrials.gov Identifier:

NCT05005871

Other Study ID Numbers:

UNUD-CTR-FK150621-001

First Posted:

Aug 16, 2021

Last Update Posted:

Oct 19, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Acute Pain

Study Results

No Results Posted as of Oct 19, 2021