Cesarean SectionPhase 4NCT05679375
IV and Intrathecal Ketamine in Cesarean Section
A Phase 4 study testing Intrathecal ketamine and Intravenous ketamine in people with Cesarean Section and Analgesia, run by Assiut University at 1 site in Egypt.
Trial summary
In the current study, the investigators will compare the effects of low-dose intravenous (i.v.) ketamine versus intrathecal Ketamine added to spinal anesthesia on the time to first request for analgesia and maternal pain scores and overall satisfaction in patients undergoing cesarean section. 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
- Cesarean Section, Analgesia
- What is being tested?
- Intrathecal ketamine and Intravenous ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 31 Oct 2024
- Phase
- Phase 4
- 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
- Pregnant undergoing elective cesarean section
Who cannot join
- Significant coexisting diseases (pregnancy-induced hypertension or diabetes)
- body mass index ≥40kg/m2, height <150cm
- Current use of pain medication including opioids
- history of substance abuse or hallucinations, cardiovascular disease, diabetes, multiple gestations
- chronic pain was excluded.
- contraindications to spinal anaesthesia,
- severely compromised fetus requiring general anesthesia and those patients who received labor analgesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between the Analgesic Effects of Intrathecal Versus Intravenous Ketamine After Spinal Anaesthesia for Elective Caesarean Delivery :a Randomised Trial
In the current study, the investigators will compare the effects of low-dose intravenous (i.v.) ketamine versus intrathecal Ketamine added to spinal anesthesia on the time to first request for analgesia and maternal pain scores and overall satisfaction in patients undergoing cesarean section.
- Conditions
- Cesarean Section, Analgesia
- Being tested
- Intrathecal ketamine, Intravenous ketamine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal ketamineDrug
Patients will receive intrathecal Ketamine 0.1mg/kg added to bupivacaine and morphine
Intravenous ketamineDrug
Patients will receive IV Ketamine 0.25mg/kg after spinal
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal Ketamine | Active comparator | Patients will receive intrathecal Ketamine 0.1mg/kg added to bupivacaine and morphine. Receives: Drug: Intrathecal ketamine |
| Intravenous ketamine | Active comparator | Patients will receive IV Ketamine 0.25mg/kg after spinal anesthesia with bupivacaine and morphine. Receives: Drug: Intravenous ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the first analgesic request
Measured: First Postoperative day
Secondary outcomes (1)
Postoperative pain scores NRS at rest and on movement; (2, 4, 6, 12, and 24 hours) postoperative
Measured: first postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start1 Feb 2023
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youstina Tharwat Sedky, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679375
- Sponsor's protocol ID
- Ketamine in Cesarean section
- Status last verified
- Mar 2025
- First submitted
- 12 Dec 2022
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abd El-Rahman AM, Mohamed AA, Mohamed SA, Mostafa MAM. Effect of Intrathecally Administered Ketamine, Morphine, and Their Combination Added to Bupivacaine in Patients Undergoing Major Abdominal Cancer Surgery a Randomized, Double-Blind Study. Pain Med. 2018 Mar 1;19(3):561-568. doi: 10.1093/pm/pnx105.
PubMed 28520955
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Analgesic Effects of Intrathecal Versus Intravenous Ketamine After Spinal Anaesthesia for Elective Caesarean Delivery :a Randomised Trial
- ClinicalTrials.gov ID
- NCT05679375
- Acronym / sponsor ID
- Ketamine in Cesarean section
- Conditions
- Cesarean Section, Analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 11 Jan 2023 (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.
In the current study, the investigators will compare the effects of low-dose intravenous (i.v.) ketamine versus intrathecal Ketamine added to spinal anesthesia on the time to first request for analgesia and maternal pain scores and overall satisfaction in patients undergoing cesarean section.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrathecal Ketamine | Active comparator | Drug: Intrathecal ketaminePatients will receive intrathecal Ketamine 0.1mg/kg added to bupivacaine and morphine. |
| Intravenous ketamine | Active comparator | Drug: Intravenous ketaminePatients will receive IV Ketamine 0.25mg/kg after spinal anesthesia with bupivacaine and morphine. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant undergoing elective cesarean section
Key exclusion criteria (7 listed)
- Significant coexisting diseases (pregnancy-induced hypertension or diabetes)
- body mass index ≥40kg/m2, height <150cm
- Current use of pain medication including opioids
- history of substance abuse or hallucinations, cardiovascular disease, diabetes, multiple gestations
- chronic pain was excluded.
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 |
|---|---|---|
| Intrathecal ketaminePatients will receive intrathecal Ketamine 0.1mg/kg added to bupivacaine and morphine | Drug | Intrathecal Ketamine |
| Intravenous ketaminePatients will receive IV Ketamine 0.25mg/kg after spinal | Drug | Intravenous ketamine |
Primary outcome
Time to the first analgesic request
Time frame: First Postoperative day
1 secondary outcome
Postoperative pain scores NRS at rest and on movement; (2, 4, 6, 12, and 24 hours) postoperative
Time frame: first postoperative day
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 6 Mar 2025.
- Background: PubMed 28520955Abd El-Rahman AM, Mohamed AA, Mohamed SA, Mostafa MAM. Effect of Intrathecally Administered Ketamine, Morphine, and Their Combination Added to Bupivacaine in Patients Undergoing Major Abdominal Cancer Surgery a Randomized, Double-Blind Study. Pain Med. 2018 Mar 1;19(3):561-568. doi: 10.1093/pm/pnx105.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section
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Cesarean Section (MeSH: D002585), Postoperative Pain After Cesarean Section
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Respiratory Distress and Elective Cesarean Section at Term
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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.
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 Phase 4 study testing Intrathecal ketamine and Intravenous ketamine in people with Cesarean Section and Analgesia, run by Assiut 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 7 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 6 Mar 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 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. 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?
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?
Time to the first analgesic request (time frame: First Postoperative day). 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 NCT05679375, which also lists 1 linked publication.
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 6 Mar 2025.