Cesarean SectionPhase 4NCT06715657
Effect of Propofol Administration Time on the Incidence and Severity of Intrathecal Morphine-induced Pruritus in Parturient Undergoing Elective Cesarean Delivaries
A Phase 4 study testing Morphine intrathecal and propofol in people with Cesarean Section, run by Assiut University.
Trial summary
Our hypothesis suggests that Administration time of intravenous propofol may affect Pruritus incidence and severity that occur after intrathecal morphine in parturient undergoing elective cesarean section (CS). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Morphine intrathecal and propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 1 Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Parturient of American Society of Anaesthesiologists (ASA) class I or II physical status.
- Age: 20-40 years.
- At term gestation (≥ 37 weeks) with a singleton uncomplicated pregnancy.
- Elective cesarean delivery under intrathecal anaesthesia
Who cannot join
- Parturient refusal.
- Significant organ dysfunctions (e.g., cardiac, respiratory, renal, or liver disorders).
- Morbid obesity (BMI >35).
- Parturient with known hypersensitivity to propofol, morphine or amide local anaesthetics.
- Parturient with pruritogenic systemic disease.
- A coexisting skin disorder or preexisting pregnancy induced pruritus.
Show all 9Show fewer
- Parturient with any contraindication for intrathecal anaesthesia, e.g. coagulopathy.
- Emergency cesarean section.
- Failed or unsatisfactory intrathecal block.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Propofol Administration Time on the Incidence and Severity of Intrathecal Morphine-induced Pruritus in Parturient Undergoing Elective Cesarean Delivaries: A Prospective, Randomized, Comparative Controlled Study
Our hypothesis suggests that Administration time of intravenous propofol may affect Pruritus incidence and severity that occur after intrathecal morphine in parturient undergoing elective cesarean section (CS). the aim of the study is to investigate effect of prophylactic administration of intravenous sub-hypnotic dose of propofol before intrathecal morphine compared with the administration after intrathecal morphine on intrathecal morphine-induced pruritus incidence and severity in parturient undergoing elective cesarean delivaries.
Read the detailed description
Neuraxial Anaesthesia is a frequent anaesthetic approach for cesarean delivery and other lower abdominal and lower limb anaesthetic procedures. Neuraxial morphine addition to local anaesthetic provides an effective and prolonged postoperative analgesia, but has been associated with a frequent incidence of pruritus and postoperative nausea and vomiting (PONV).
Neuraxial opioids are thought to act on central nervous system pathways to cause pruritus. Although precise mechanisms are incompletely understood, Numerous interventions have been investigated to prevent opioid-induced pruritus in the peripartum period as: Opioid receptor agonist-antagonists, Serotonin receptor antagonists.
There is dense concentration of opioid receptors and 5-HT3 receptors in the dorsal part of the spinal cord and nucleus of the spinal tract of the trigeminal nerve in the medulla. Activation of these receptors by neuraxial opioid administration or by circulating estrogen in parturient results in pruritus which is usually localized to face, neck, or upper thorax.
Propofol exerts its antipruritic action through inhibition of the posterior horn transmission in spinal cord. Series of clinical trials have reported that a sub-hypnotic dose of propofol is equally effective in reducing the incidence of pruritus following intrathecal morphine. however these studies have limited information about dose and timing of administration of propofol.
- Conditions
- Cesarean Section
- Being tested
- Morphine intrathecal, propofol
- Keywords
- propofol administration time, intrathecal morphine-induced pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphine intrathecalDrug
patients intrathecal anaesthesia with morphine
propofolDrug
patients will receive 0.5 mg/kg propofol diluted in 10 ml saline 0.9% IV injection 15 min before the end of surgery
propofolDrug
patients will receive 0.5 mg/kg propofol diluted in 10 ml saline 0.9% IV injection just before intrathecal anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients will receive 0.5 mg/kg propofol diluted in 10 ml saline 0.9% IV injection 15 min before the end of surgery Receives: Drug: Morphine intrathecal; Drug: propofol |
| Group B | Experimental | Patients will receive 0.5 mg/kg propofol diluted in 10 ml saline 0.9% IV injection just before intrathecal anaesthesia Receives: Drug: Morphine intrathecal; Drug: propofol |
| Group C | Placebo comparator | patients will receive intrathecal anaesthesia with morphine without other intervention Receives: Drug: Morphine intrathecal |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity of pruritus that occurs after intrathecal morphine in parturient undergoing elective cesarean section (CS) by pruritus Grading system.
the pruritus grading score (PGS) score (Firas et al, 2012) for each patient which is based on: distribution, frequency, severity of itch, and quality of sleep
Each patient's itch grade is calculated as the sum of the individual scores:
Mild grade: if the total score is between 0 and 5. Moderate grade: if the total score is between 6 and 11. Severe grade: if the total score is between 12 and 19.
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 posted4 Dec 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Assiut 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Essam Elsayed Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06715657
- Sponsor's protocol ID
- propofol pruritus incidence CS
- Status last verified
- Nov 2024
- First submitted
- 29 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kumar K, Singh SI. Neuraxial opioid-induced pruritus: An update. J Anaesthesiol Clin Pharmacol. 2013 Jul;29(3):303-7. doi: 10.4103/0970-9185.117045.
PubMed 24106351Singh PM, Sultan P, O'Carroll J, Blake L, Carvalho B, Singh NP, Monks DT. Pharmacological agents for prevention of pruritus in women undergoing Caesarean delivery with neuraxial morphine: a systematic review and Bayesian network meta-analysis. Br J Anaesth. 2023 Sep;131(3):556-571. doi: 10.1016/j.bja.2023.05.028. Epub 2023 Jul 14.
PubMed 37455197Kampo S, Afful AP, Mohammed S, Ntim M, Buunaaim ADB, Anabah TW. Sub-hypnotic dose of propofol as antiemetic prophylaxis attenuates intrathecal morphine-induced postoperative nausea and vomiting, and pruritus in parturient undergoing cesarean section - a randomized control trial. BMC Anesthesiol. 2019 Sep 14;19(1):177. doi: 10.1186/s12871-019-0847-y.
PubMed 31521119
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Propofol Administration Time on the Incidence and Severity of Intrathecal Morphine-induced Pruritus in Parturient Undergoing Elective Cesarean Delivaries: A Prospective, Randomized, Comparative Controlled Study
- ClinicalTrials.gov ID
- NCT06715657
- Acronym / sponsor ID
- propofol pruritus incidence CS
- Conditions
- Cesarean Section
- Keywords
- propofol administration time, intrathecal morphine-induced pruritus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 4 Dec 2024 (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.
Our hypothesis suggests that Administration time of intravenous propofol may affect Pruritus incidence and severity that occur after intrathecal morphine in parturient undergoing elective cesarean section (CS). the aim of the study is to investigate effect of prophylactic administration of intravenous sub-hypnotic dose of propofol before intrathecal morphine compared with the administration after intrathecal morphine on intrathecal morphine-induced pruritus incidence and severity in parturient undergoing elective cesarean delivaries.
Detailed description
Neuraxial Anaesthesia is a frequent anaesthetic approach for cesarean delivery and other lower abdominal and lower limb anaesthetic procedures. Neuraxial morphine addition to local anaesthetic provides an effective and prolonged postoperative analgesia, but has been associated with a frequent incidence of pruritus and postoperative nausea and vomiting (PONV).
Neuraxial opioids are thought to act on central nervous system pathways to cause pruritus. Although precise mechanisms are incompletely understood, Numerous interventions have been investigated to prevent opioid-induced pruritus in the peripartum period as: Opioid receptor agonist-antagonists, Serotonin receptor antagonists.
There is dense concentration of opioid receptors and 5-HT3 receptors in the dorsal part of the spinal cord and nucleus of the spinal tract of the trigeminal nerve in the medulla. Activation of these receptors by neuraxial opioid administration or by circulating estrogen in parturient results in pruritus which is usually localized to face, neck, or upper thorax.
Propofol exerts its antipruritic action through inhibition of the posterior horn transmission in spinal cord. Series of clinical trials have reported that a sub-hypnotic dose of propofol is equally effective in reducing the incidence of pruritus following intrathecal morphine. however these studies have limited information about dose and timing of administration of propofol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Morphine intrathecal, Drug: propofolPatients will receive 0.5 mg/kg propofol diluted in 10 ml saline 0.9% IV injection 15 min before the end of surgery |
| Group B | Experimental | Drug: Morphine intrathecal, Drug: propofolPatients will receive 0.5 mg/kg propofol diluted in 10 ml saline 0.9% IV injection just before intrathecal anaesthesia |
| Group C | Placebo comparator | Drug: Morphine intrathecalpatients will receive intrathecal anaesthesia with morphine without other intervention |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Parturient of American Society of Anaesthesiologists (ASA) class I or II physical status.
- Age: 20-40 years.
- At term gestation (≥ 37 weeks) with a singleton uncomplicated pregnancy.
- Elective cesarean delivery under intrathecal anaesthesia
Key exclusion criteria (9 listed)
- Parturient refusal.
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 |
|---|---|---|
| Morphine intrathecalpatients intrathecal anaesthesia with morphine | Drug | Group A, Group B, Group C |
| propofolpatients will receive 0.5 mg/kg propofol diluted in 10 ml saline 0.9% IV injection 15 min before the end of surgery | Drug | Group A |
| propofolpatients will receive 0.5 mg/kg propofol diluted in 10 ml saline 0.9% IV injection just before intrathecal anaesthesia | Drug | Group B |
Primary outcome
severity of pruritus that occurs after intrathecal morphine in parturient undergoing elective cesarean section (CS) by pruritus Grading system.
Time frame: 24 hours
the pruritus grading score (PGS) score (Firas et al, 2012) for each patient which is based on: distribution, frequency, severity of itch, and quality of sleep Each patient's itch grade is calculated as the sum of the individual scores: Mild grade: if the total score is between 0 and 5. Moderate grade: if the total score is between 6 and 11. Severe grade: if the total score is between 12 and 19.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Results publication: PubMed 24106351Kumar K, Singh SI. Neuraxial opioid-induced pruritus: An update. J Anaesthesiol Clin Pharmacol. 2013 Jul;29(3):303-7. doi: 10.4103/0970-9185.117045.
- Results publication: PubMed 37455197Singh PM, Sultan P, O'Carroll J, Blake L, Carvalho B, Singh NP, Monks DT. Pharmacological agents for prevention of pruritus in women undergoing Caesarean delivery with neuraxial morphine: a systematic review and Bayesian network meta-analysis. Br J Anaesth. 2023 Sep;131(3):556-571. doi: 10.1016/j.bja.2023.05.028. Epub 2023 Jul 14.
- Results publication: PubMed 31521119Kampo S, Afful AP, Mohammed S, Ntim M, Buunaaim ADB, Anabah TW. Sub-hypnotic dose of propofol as antiemetic prophylaxis attenuates intrathecal morphine-induced postoperative nausea and vomiting, and pruritus in parturient undergoing cesarean section - a randomized control trial. BMC Anesthesiol. 2019 Sep 14;19(1):177. doi: 10.1186/s12871-019-0847-y.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Morphine intrathecal and propofol in people with Cesarean Section, run by Assiut University.
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 4 inclusion and 9 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: opening soon, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esraa Essam Elsayed Mohamed, resident doctor (+201004879065, Esraa.16282364@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
severity of pruritus that occurs after intrathecal morphine in parturient undergoing elective cesarean section (CS) by pruritus Grading system. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06715657, which also lists 3 linked publications.
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 4 Dec 2024.