NCT05005871

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 16, 2021

Completed
16 days until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2021

Completed
Last Updated

October 19, 2021

Status Verified

October 1, 2021

Enrollment Period

29 days

First QC Date

June 15, 2021

Last Update Submit

October 18, 2021

Conditions

Pain, PostoperativePain, AcuteCesarean Section Complications

Outcome Measures

Primary Outcomes (2)

  • Postoperative pain

    Postoperative pain intensity measured by Visual Analog Scale (VAS), 0=no pain, 100=worst pain

    Up to 24 hours after surgery

  • 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

Study Arms (2)

Quadratus lumborum intramuscular block

ACTIVE COMPARATOR

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

Quadratus lumborum transmucular block

ACTIVE COMPARATOR

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

Interventions

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

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

Quadratus lumborum intramuscular blockQuadratus lumborum transmucular block

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Underwent C-section with subarachnoid block
  • Aged 18-35 years old.
  • ASA preoperative physical status 1-2

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanglah General Hospital

Denpasar, Bali, 80114, Indonesia

Location

MeSH Terms

Conditions

Pain, PostoperativeAcute Pain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 15, 2021

First Posted

August 16, 2021

Study Start

September 1, 2021

Primary Completion

September 30, 2021

Study Completion

October 14, 2021

Last Updated

October 19, 2021

Record last verified: 2021-10

Locations

ID(1)