Chronic Post Cesarean PainNCT05602038
Comparative Study on the Effect of Quadratus Lumborum Block Versus Intrathecal Morphine on the Incidence of Chronic Pain Post Caesarean Section
A study testing Quadratus laborum block, Intrathecal morphine and intrathecal bupivacaine in people with Chronic Post Cesarean Pain, run by Menoufia University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the incidence of CPSCP in patients receiving QLB quadratus lumborum block and ITM versus control as a primary outcome and associated risk factors that might predispose patients to develop CPSCP. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Post Cesarean Pain
- What is being tested?
- Quadratus laborum block, Intrathecal morphine and intrathecal bupivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 12 Dec 2023
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients admitted to the operating theatre for elective caesarean section
Who cannot join
- lack of informed consent
- Allergy to drugs used during the study
- Depression and epilepsy that required antidepressants or anticonvulsants
- known coagulopathy as a contraindication for spinal anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quadratus Lumborum Block Versus Intrathecal Morphine for Prevention of Chronic Post-Caesarean Pain: A Four-Arm Randomised Controlled Trial
The aim of this study is to compare the incidence of CPSCP in patients receiving QLB quadratus lumborum block and ITM versus control as a primary outcome and associated risk factors that might predispose patients to develop CPSCP.
Read the detailed description
The aim of this study is to compare the incidence of chronic post cesarean pain in patients receiving quadratus laborum block and and intrathecal morphine versus control as a primary
Study design:
Patients will be randomly allocated to the procedure through closed envelopes and so syringes and medication will be prepared and labelled by anesthetist other than the anesthetist giving the block Patients will be randomly allocated to the procedure through closed envelopes and so syringes and medication will be prepared and labelled by anesthetist other than the anesthetist giving the block Data will be collected regarding the demographic data, gestational stage, parity and number of previous cesarean section, previous abdominal surgeries, and narcotic consumption.
Postoperative pain day 1 and day2 will be followed by anesthetist who is blinded to the applied technique used. Follow up for the subsequent period of observation (2,4and 6 months) will be done by a blinded research nurse who will contact the patients by phone to ask them if there is any "concern" after the operation. If the patient refers to a pain at the surgical site that has been lasting for the past three months a call will be conducted by the anesthetist and a referral schedule will be appointed to the pain clinic consultant for further evaluation
- Conditions
- Chronic Post Cesarean Pain
- Being tested
- Quadratus laborum block, Intrathecal morphine, intrathecal bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadratus laborum blockProcedure or surgery
quadratus lumborum block will be performed using ultrasound machine (Sonosite Portable Ultrasound System, SonoSite, Bothell, Washington, USA). A 5-8 MHZ curved probe will be used with the patient positioned on the lateral side
Intrathecal morphineDrug
Intrathecal morphine 100mcg will be added to bupivacaine 0.5% 15mg and fentanyl 20 µg
intrathecal bupivacaineDrug
intrathecal bupivacaine 0.5% 15mg and fentanyl
| Study group | Role | What they receive |
|---|---|---|
| Group Q | Active comparator | QLB group will receive 30 ml 0.125% bupivacaine (Sunnypivacaine by Sunny Pharmaceuticals) for each side Receives: Procedure: Quadratus laborum block; Drug: intrathecal bupivacaine |
| Group M | Active comparator | Intrathecal morphine 100mcg will be added to bupivacaine 0.5% 15mg and fentanyl 20 µg Receives: Drug: Intrathecal morphine; Drug: intrathecal bupivacaine |
| Group QM | Active comparator | Intrathecal morphine 100mcg will be added to bupivacaine 0.5% 15mg and fentanyl 20 µg combined by QLB of 30 ml 0.125%bupivacain Receives: Procedure: Quadratus laborum block; Drug: Intrathecal morphine; Drug: intrathecal bupivacaine |
| Group C | Placebo comparator | Control group with intrathecal bupivacaine 0.5% 15mg and fentanyl 20 µg. Receives: Drug: intrathecal bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic pain incidence at 6monthes
Pain at six monthes
Measured: Six months
Secondary outcomes (1)
Visual analogue scale
Acute pain assessment
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start1 Feb 2023
- Primary completion1 Dec 2023
- Study completion12 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Post Cesarean PainStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized control study
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rabab Mohammad habeeb, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602038
- Sponsor's protocol ID
- 10/2022ANET1-3
- Status last verified
- Aug 2026
- First submitted
- 24 Oct 2022
- Last updated
- 14 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quadratus Lumborum Block Versus Intrathecal Morphine for Prevention of Chronic Post-Caesarean Pain: A Four-Arm Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05602038
- Acronym / sponsor ID
- 10/2022ANET1-3
- Conditions
- Chronic Post Cesarean Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 1 Nov 2022 (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.
The aim of this study is to compare the incidence of CPSCP in patients receiving QLB quadratus lumborum block and ITM versus control as a primary outcome and associated risk factors that might predispose patients to develop CPSCP.
Detailed description
The aim of this study is to compare the incidence of chronic post cesarean pain in patients receiving quadratus laborum block and and intrathecal morphine versus control as a primary
Study design:
Patients will be randomly allocated to the procedure through closed envelopes and so syringes and medication will be prepared and labelled by anesthetist other than the anesthetist giving the block Patients will be randomly allocated to the procedure through closed envelopes and so syringes and medication will be prepared and labelled by anesthetist other than the anesthetist giving the block Data will be collected regarding the demographic data, gestational stage, parity and number of previous cesarean section, previous abdominal surgeries, and narcotic consumption.
Postoperative pain day 1 and day2 will be followed by anesthetist who is blinded to the applied technique used. Follow up for the subsequent period of observation (2,4and 6 months) will be done by a blinded research nurse who will contact the patients by phone to ask them if there is any "concern" after the operation. If the patient refers to a pain at the surgical site that has been lasting for the past three months a call will be conducted by the anesthetist and a referral schedule will be appointed to the pain clinic consultant for further evaluation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- randomized control study
| Arm | Type | Receives |
|---|---|---|
| Group Q | Active comparator | Procedure: Quadratus laborum block, Drug: intrathecal bupivacaineQLB group will receive 30 ml 0.125% bupivacaine (Sunnypivacaine by Sunny Pharmaceuticals) for each side |
| Group M | Active comparator | Drug: Intrathecal morphine, Drug: intrathecal bupivacaineIntrathecal morphine 100mcg will be added to bupivacaine 0.5% 15mg and fentanyl 20 µg |
| Group QM | Active comparator | Procedure: Quadratus laborum block, Drug: Intrathecal morphine, Drug: intrathecal bupivacaineIntrathecal morphine 100mcg will be added to bupivacaine 0.5% 15mg and fentanyl 20 µg combined by QLB of 30 ml 0.125%bupivacain |
| Group C | Placebo comparator | Drug: intrathecal bupivacaineControl group with intrathecal bupivacaine 0.5% 15mg and fentanyl 20 µg. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients admitted to the operating theatre for elective caesarean section
Key exclusion criteria (4 listed)
- lack of informed consent
- Allergy to drugs used during the study
- Depression and epilepsy that required antidepressants or anticonvulsants
- known coagulopathy as a contraindication for spinal anesthesia
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 laborum blockquadratus lumborum block will be performed using ultrasound machine (Sonosite Portable Ultrasound System, SonoSite, Bothell, Washington, USA). A 5-8 MHZ curved probe will be used with the patient positioned on the lateral side | Procedure or surgery | Group Q, Group QM |
| Intrathecal morphineIntrathecal morphine 100mcg will be added to bupivacaine 0.5% 15mg and fentanyl 20 µg | Drug | Group M, Group QM |
| intrathecal bupivacaineintrathecal bupivacaine 0.5% 15mg and fentanyl | Drug | Group C, Group M, Group Q, Group QM |
Primary outcome
Chronic pain incidence at 6monthes
Time frame: Six months
Pain at six monthes
1 secondary outcome
Visual analogue scale
Time frame: 48 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 14 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Post Cesarean Pain
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Dinalbuphine Ester (Naldebain) for Pain Management After Cesarean Section
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Analysis of the Incidence and Risk Factors of Chronic Pain After Cesarean Section
Postoperative Pain, Cesarean Section Surgery
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.
The record lists no contact. Use the official record to reach the sponsor.
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 laborum block, Intrathecal morphine and intrathecal bupivacaine in people with Chronic Post Cesarean Pain, run by Menoufia University at 1 site in Egypt.
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 1 inclusion and 4 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 14 Aug 2026. 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 Egypt. 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?
Chronic pain incidence at 6monthes (time frame: Six months). 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 14 Aug 2026.