Comparison of Quadratus Lumborum Intramuscular and Transmuscular in Postoperative Pain

NCT ID: NCT05005871

Last Updated: 2021-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2021-10-14

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.

Conditions

Pain, Postoperative; Pain, Acute; Cesarean Section Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Udayana University

OTHER

Sponsor Role: lead

Responsible Party

Christopher Ryalino, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sanglah General Hospital

Denpasar, Bali, Indonesia

Countries

Indonesia

Other Identifiers

UNUD-CTR-FK150621-001

Identifier Type: -

Identifier Source: org_study_id