NCT03673280

Brief Summary

Postoperative pain of a caesarean section may be of high intensity, especially in the first 48 hours after the procedure, which affects the mother / newborn relationship, in addition to having the potential to progress to chronic pain. The use of intrathecal morphine is effective in post-caesarean analgesia, but carries unwanted side effects, including nausea, vomiting, urinary retention and pruritus. Therefore, alternative techniques of analgesia become necessary. First described in 2007, ultrasound-guided quadratus lumborum (QL) block has gained prominence due to its analgesic superiority to the TAP block. Besides providing somatic analgesia, it also seems to inhibit visceral pain because the local anesthetic reaches the paravertebral space, this was observed by magnetic resonance imaging with contrast medium injected at the QL block site.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Longer than P75 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 17, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

October 2, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2020

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

1.4 years

First QC Date

September 3, 2018

Last Update Submit

February 11, 2025

Conditions

Postoperative Analgesia

Keywords

intrathecal morphinequadratus lumborum blockcesarean c-sectionpostoperative painchronic pain

Outcome Measures

Primary Outcomes (2)

  • Morphine consumption

    Evaluate pain in the postoperative period with to the consumption of morphine through PCA (patient controlled analgesia) pump.

    24 hours

  • Pain intensity

    Verbal numeric scale

    24 hours

Secondary Outcomes (4)

  • Nausea and Vomiting

    24 hours

  • Pruritus

    24 hours

  • Chronic pain

    3 months

  • Urinary retention

    24 hours

Study Arms (3)

Classical spinal anesthesia

PLACEBO COMPARATOR

Patients allocated to this group will receive spinal anesthesia with bupivacaine 12.5mg, Fentanyl 20mcg and Morphine 80mcg + placebo quadratus lumborum block.

Procedure: Quadratus Lumborum Block

Spinal anaesthesia with block

EXPERIMENTAL

Patients allocated to this group will receive spinal anesthesia with bupivacaine 12.5mg, Fentanyl 20mcg + quadratus lumborum block.

Procedure: Quadratus Lumborum Block

Classical anaesthesia plus block

EXPERIMENTAL

Patients allocated to this group will receive spinal anesthesia with bupivacaine 12.5mg, Fentanyl 20mcg and Morphine 80mcg + quadratus lumborum block.

Procedure: Quadratus Lumborum Block

Interventions

Quadratus Lumborum BlockPROCEDURE

Instead of using morphine in the classical spinal anaesthesia we will be performing in the experimental group the Quadratus Lumborum Block

Also known as: Remove morphine from the spinal block
Classical anaesthesia plus blockClassical spinal anesthesiaSpinal anaesthesia with block

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Minimum age of 18 years
  • Minimum gestational age of 37 weeks with a single fetus
  • Patients scheduled for elective cesarean section through a Pfannenstiel incision under spinal anesthesia
  • American Society of Anesthesiology physical status (ASA) II
  • Body mass index (BMI) under 40 kg/m²
  • No use of opioids for the past 4 weeks
  • No history of psychotropic drug use
  • No contraindication for any of the medications involved in the study
  • No previously known malformations of the fetus
  • No previous history of chronic pain

You may not qualify if:

  • Difficulty in understanding how to use the patient-controlled analgesia (PCA) device
  • Study protocol violation
  • Patient decision to withdraw participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, 05403000, Brazil

Location

MeSH Terms

Conditions

Pain, PostoperativeChronic Pain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Hermann S Fernandes, MD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Clinical, analytical, prospective, randomized trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 3, 2018

First Posted

September 17, 2018

Study Start

October 2, 2018

Primary Completion

February 25, 2020

Study Completion

July 1, 2024

Last Updated

February 12, 2025

Record last verified: 2025-02

Locations

BR(1)