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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05005871
Other study ID # UNUD-CTR-FK150621-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2021
Est. completion date October 14, 2021

Study information

Verified date October 2021
Source Udayana University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date October 14, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 35 Years
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Indonesia Sanglah General Hospital Denpasar Bali

Sponsors (1)

Lead Sponsor Collaborator
Udayana University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative pain Postoperative pain intensity measured by Visual Analog Scale (VAS), 0=no pain, 100=worst pain Up to 24 hours after surgery
Primary 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) Up to 72 hours after surgery
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