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CompletedNCT03673280QUALICSUpdated Feb 12, 2025

Quadratus Lumborum in Cesarean Section Trial

An interventional study of Quadratus Lumborum Block in Postoperative Analgesia, sponsored by University of Sao Paulo General Hospital. Completed at 1 site in Brazil. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-12.

Sponsored by University of Sao Paulo General Hospital · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
61
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the detailed description

C-section is one of the most performed surgical procedures in the world, and presents great potential for postoperative pain, especially in the first 48 hours. Pain in this period represents a risk for evolution to chronic pain, but its incidence is still very divergent when comparing the studies, ranging from 1% to 18%.

The use of intrathecal morphine (MIT) is consecrated as a first-choice method of analgesia for post-partum cesarean delivery; however, its use carries relevant side effects for the puerpera, such as pruritus, nausea, urinary retention and , more rarely, respiratory depression. In the last decade, new adjunctive forms of postoperative analgesia have become more popular, such as regional blockades, highlighting the blockage of the Transversus Abdominis plane block (TAP) and the Quadratus Lumborum block (QL), taking as benefits the prolonged analgesia they provide and the low incidence of side effects. Another factor that contributes to the popularization of regional blocks is the increasing availability of ultrasound devices in the anesthetic-surgical environment. Studies evaluating TAP block after cesarean section performed under spinal anesthesia have shown a discrete benefit in decreasing postoperative opioid consumption in addition to improving pain scores. When comparing MIT with TAP block, the superiority of MIT is due to visceral analgesia while TAP block is restricted to abdominal wall analgesia.

Ultrasound-guided Lumbar Quadrant blockade has gained prominence due to its analgesic superiority over the TAP block, because in addition to providing somatic analgesia it also seems to inhibit visceral pain since the local anesthetic reaches the paravertebral space, this was observed by magnetic resonance imaging with contrast injected at the site of the QL block.

Reviewing the literature in 2018, there are no clinical trials comparing the use of intrathecal morphine with the quadratus lumborum block.

02

Conditions studied

  • Postoperative Analgesia

Keywords

  • intrathecal morphine
  • quadratus lumborum block
  • cesarean c-section
  • postoperative pain
  • chronic pain
03

In context

Lead sponsor

University of Sao Paulo General Hospital is the lead sponsor of 595 studies on the registry; 98 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Difficulty in understanding how to use the patient-controlled analgesia (PCA) device
  • Study protocol violation
  • Patient decision to withdraw participation
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
61 participants (actual)

Study arms

  • Placebo comparator
    Classical spinal anesthesia

    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

  • Experimental
    Spinal anaesthesia with block

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

    Procedure: Quadratus Lumborum Block

  • Experimental
    Classical anaesthesia plus block

    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

  • ProcedureQuadratus Lumborum Block

    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

06

What researchers measure

Primary outcomes

  1. Morphine consumption

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

    Time frame: 24 hours

  2. Pain intensity

    Verbal numeric scale

    Time frame: 24 hours

Secondary outcomes

  1. Nausea and Vomiting

    Evaluate the incidence of nausea and vomiting between the groups through referred nausea scale from none, mild, moderate or severe.

    Time frame: 24 hours

  2. Pruritus

    Evaluate the incidence of pruritus between the groups through pruritus referred scale from none, mild, moderate or severe.

    Time frame: 24 hours

  3. Chronic pain

    Evaluate the incidence of chronic pain between the groups through patient referred presence or absence of pain.

    Time frame: 3 months

  4. Urinary retention

    Evaluate the incidence of urinary retention between the groups through patient referred presence or absence of urinary retention.

    Time frame: 24 hours

07

Study locations

1 site
  • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
    São Paulo, 05403000, Brazil
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03673280
Lead sponsor
University of Sao Paulo General Hospital
Responsible party
Hermann dos Santos Fernandes (MD, University of Sao Paulo General Hospital) — Principal investigator
First posted
Sep 17, 2018
Start date
Oct 2, 2018
Primary completion
Feb 25, 2020
Completion
Jul 1, 2024
Last update
Feb 12, 2025

Study contacts

Hermann S Fernandes, MD
principal investigator · University of Sao Paulo

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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