Cesarean SectionNCT04545801
Ketamine for Analgesia After Cesarean Section
A study testing 0.25 mg/kg of Ketamine and 20ml of normal saline solution in people with Cesarean Section and Postoperative Pain, run by Mongi Slim Hospital at 1 site in Tunisia.
Trial summary
In this prospective randomized trial, investigators compared the analgesic effect of subanesthetic dose of ketamine versus placebo in parturients undergoing cesarean section under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Section, Postoperative Pain
- What is being tested?
- 0.25 mg/kg of Ketamine and 20ml of normal saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Jan 2019to 30 Apr 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- full term pregnant adult patients
- Monofetal pregnancy
- scheduled for urgent or elective cesarean section under spinal anesthesia
Who cannot join
- necessity of general anesthesia during the procedure
- Post partum hemorrage
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Mongi Slim University Hospital
La Marsa, Tunis Governorate, 2046
About this study
In this prospective randomized trial, investigators compared the analgesic effect of subanesthetic dose of ketamine versus placebo in parturients undergoing cesarean section under spinal anesthesia.
Read the detailed description
In this prospective randomized trial, investigators compared the analgesic effect of subanesthetic dose of ketamine versus placebo in parturients undergoing cesarean section under spinal anesthesia.
The patients were randomized in two groups:
- Group Ketamine: these patients recieved 0.25 mg/kg of Ketamin intravenously 5 minutes after the spinal anesthesia.
- Group Placebo: recieved 20 ml of normal saline solution intravenously 5 minutes after the spinal puncture.
The investigators recorded intra demographic, intraoperative and post operative data.
The main outcome was the analgesic score: the visual analog scale (VAS). dynamic VAS was also monitored at 24 hours post operatively.
- Conditions
- Cesarean Section, Postoperative Pain
- Being tested
- 0.25 mg/kg of Ketamine, 20ml of normal saline solution
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.25 mg/kg of KetamineDrug
patients will recieve 0.25mg/kg of ketamine intravenously 5 min after spinal anesthesia
20ml of normal saline solutionDrug
20ml of normal saline solution intravenously 5 minutes after spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Ketamine Group | Active comparator | Patients recieving 0.25 mg/kg of ketamine 5 minutes after spinal anesthesia Receives: Drug: 0.25 mg/kg of Ketamine |
| Placebo Group | Placebo comparator | Not described Receives: Drug: 20ml of normal saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Visual Analog Scale
Pain score VAS range from 0 to 10, high scores mean worse outcome
Measured: 24 hours after cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2020
- Study start1 Jan 2019
- Primary completion31 Mar 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mongi Slim Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mhamed Sami Mebazaa, Mongi Slim Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04545801
- Sponsor's protocol ID
- ketamine cesarean
- Status last verified
- Sep 2020
- First submitted
- 4 Sep 2020
- Last updated
- 16 Sep 2020
- 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 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine for Analgesia After Cesarean Section
- ClinicalTrials.gov ID
- NCT04545801
- Acronym / sponsor ID
- ketamine cesarean
- Conditions
- Cesarean Section, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mongi Slim HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 11 Sep 2020 (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 this prospective randomized trial, investigators compared the analgesic effect of subanesthetic dose of ketamine versus placebo in parturients undergoing cesarean section under spinal anesthesia.
Detailed description
In this prospective randomized trial, investigators compared the analgesic effect of subanesthetic dose of ketamine versus placebo in parturients undergoing cesarean section under spinal anesthesia.
The patients were randomized in two groups:
- Group Ketamine: these patients recieved 0.25 mg/kg of Ketamin intravenously 5 minutes after the spinal anesthesia.
- Group Placebo: recieved 20 ml of normal saline solution intravenously 5 minutes after the spinal puncture.
The investigators recorded intra demographic, intraoperative and post operative data.
The main outcome was the analgesic score: the visual analog scale (VAS). dynamic VAS was also monitored at 24 hours post operatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine Group | Active comparator | Drug: 0.25 mg/kg of KetaminePatients recieving 0.25 mg/kg of ketamine 5 minutes after spinal anesthesia |
| Placebo Group | Placebo comparator | Drug: 20ml of normal saline solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- full term pregnant adult patients
- Monofetal pregnancy
- scheduled for urgent or elective cesarean section under spinal anesthesia
Key exclusion criteria (2 listed)
- necessity of general anesthesia during the procedure
- Post partum hemorrage
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 |
|---|---|---|
| 0.25 mg/kg of Ketaminepatients will recieve 0.25mg/kg of ketamine intravenously 5 min after spinal anesthesia | Drug | Ketamine Group |
| 20ml of normal saline solution20ml of normal saline solution intravenously 5 minutes after spinal anesthesia | Drug | Placebo Group |
Primary outcome
Dynamic Visual Analog Scale
Time frame: 24 hours after cesarean section
Pain score VAS range from 0 to 10, high scores mean worse outcome
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 16 Sep 2020.
- Individual participant dataSharing planned: No
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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 study testing 0.25 mg/kg of Ketamine and 20ml of normal saline solution in people with Cesarean Section and Postoperative Pain, run by Mongi Slim Hospital at 1 site in Tunisia.
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 3 inclusion and 2 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 16 Sep 2020. 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 Tunisia. 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?
Dynamic Visual Analog Scale (time frame: 24 hours after cesarean section). 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 16 Sep 2020.