Postoperative AnalgesiaQUALICSNCT03673280
Quadratus Lumborum in Cesarean Section Trial
A study testing Quadratus Lumborum Block in people with Postoperative Analgesia, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Analgesia
- What is being tested?
- Quadratus Lumborum Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Oct 2018to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- Difficulty in understanding how to use the patient-controlled analgesia (PCA) device
- Study protocol violation
- Patient decision to withdraw participation
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, 05403000
About this study
Official title: Comparison Between Intrathecal Morphine and Quadratus Lumborum Block for Postpartum Analgesia of Elective Cesareans.
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.
- Conditions
- Postoperative Analgesia
- Being tested
- Quadratus Lumborum Block
- Keywords
- intrathecal morphine, quadratus lumborum block, cesarean c-section, postoperative pain, chronic pain
- Medical subject headings
- Pain, Postoperative, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadratus Lumborum BlockProcedure or surgery
Also called Remove morphine from the spinal block
Instead of using morphine in the classical spinal anaesthesia we will be performing in the experimental group the Quadratus Lumborum Block
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Quadratus Lumborum Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption
Evaluate pain in the postoperative period with to the consumption of morphine through PCA (patient controlled analgesia) pump.
Measured: 24 hours
Pain intensity
Verbal numeric scale
Measured: 24 hours
Secondary outcomes (4)
Nausea and Vomiting
Evaluate the incidence of nausea and vomiting between the groups through referred nausea scale from none, mild, moderate or severe.
Measured: 24 hours
Pruritus
Evaluate the incidence of pruritus between the groups through pruritus referred scale from none, mild, moderate or severe.
Measured: 24 hours
Chronic pain
Evaluate the incidence of chronic pain between the groups through patient referred presence or absence of pain.
Measured: 3 months
Urinary retention
Evaluate the incidence of urinary retention between the groups through patient referred presence or absence of urinary retention.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start2 Oct 2018
- Primary completion25 Feb 2020
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical, analytical, prospective, randomized trial.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hermann dos Santos Fernandes, University of Sao Paulo General Hospital
- Investigators
- Hermann S Fernandes, MD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03673280
- Sponsor's protocol ID
- CAAE 90600818.0.0000.0068
- Acronym
- QUALICS
- Status last verified
- Feb 2025
- First submitted
- 3 Sep 2018
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Intrathecal Morphine and Quadratus Lumborum Block for Postpartum Analgesia of Elective Cesareans.
- ClinicalTrials.gov ID
- NCT03673280
- Acronym / sponsor ID
- QUALICS / CAAE 90600818.0.0000.0068
- Conditions
- Postoperative Analgesia
- Keywords
- intrathecal morphine, quadratus lumborum block, cesarean c-section, postoperative pain, chronic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- 25 Feb 2020 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 17 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Clinical, analytical, prospective, randomized trial.
| Arm | Type | Receives |
|---|---|---|
| Classical spinal anesthesia | Placebo comparator | Procedure: Quadratus Lumborum BlockPatients allocated to this group will receive spinal anesthesia with bupivacaine 12.5mg, Fentanyl 20mcg and Morphine 80mcg + placebo quadratus lumborum block. |
| Spinal anaesthesia with block | Experimental | Procedure: Quadratus Lumborum BlockPatients allocated to this group will receive spinal anesthesia with bupivacaine 12.5mg, Fentanyl 20mcg + quadratus lumborum block. |
| Classical anaesthesia plus block | Experimental | Procedure: Quadratus Lumborum BlockPatients allocated to this group will receive spinal anesthesia with bupivacaine 12.5mg, Fentanyl 20mcg and Morphine 80mcg + quadratus lumborum block. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (3 listed)
- Difficulty in understanding how to use the patient-controlled analgesia (PCA) device
- Study protocol violation
- Patient decision to withdraw participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quadratus Lumborum BlockAlso: Remove morphine from the spinal blockInstead of using morphine in the classical spinal anaesthesia we will be performing in the experimental group the Quadratus Lumborum Block | Procedure or surgery | Classical anaesthesia plus block, Classical spinal anesthesia, Spinal anaesthesia with block |
Primary outcome
Morphine consumption
Time frame: 24 hours
Evaluate pain in the postoperative period with to the consumption of morphine through PCA (patient controlled analgesia) pump.
Pain intensity
Time frame: 24 hours
Verbal numeric scale
4 secondary outcomes
Nausea and Vomiting
Time frame: 24 hours
Pruritus
Time frame: 24 hours
Chronic pain
Time frame: 3 months
Urinary retention
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hermann S Fernandes, MD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quadratus Lumborum Block in people with Postoperative Analgesia, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine consumption (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.