Post Cesarean AnalgesiaPhase 4NCT06408974
Comparison Between Ketamine Intrathecal and iv Dexamethasone for Post Cesarean Analgesia
A Phase 4 study testing Ketamine and dexamethasone in people with Post Cesarean Analgesia, run by Assiut University.
Trial summary
The aim of our study is to compare the postoperative analgesic efficacy of intrathecal ketamine added to bupivacaine to that of intravenous dexamethasone in patients undergoing cesarean section under bupivacaine spinal anesthesia. 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
- Post Cesarean Analgesia
- What is being tested?
- Ketamine and dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 20 Dec 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
- Age between 18 and 45 years
- Body mass index (BMI) of 18-35 kg/m2
- Patients with the American Society of Anesthesiologists (ASA) physical status I/II,
- Patients scheduled for elective cesarean section .
- females. .
Who cannot join
- Patient refusal
- Allergy to local anaesthetics
- Infection at the site of injection
- Coagulopathy,
- Chronic pain syndromes
- Prolonged opioid medication
- Patients who received any analgesic 24 h before surgery
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Comparison Of Intrathecal Ketamine Versus Intravenous Dexamethasone For Postoperative Analgesia In Parturients Undergoing Spinal Anaesthesia For Cesarean Section: A Randomised Trial
The aim of our study is to compare the postoperative analgesic efficacy of intrathecal ketamine added to bupivacaine to that of intravenous dexamethasone in patients undergoing cesarean section under bupivacaine spinal anesthesia.
Read the detailed description
Caesarean delivery is associated with postoperative pain that may influence recovery, psychological maternal well-being, and breastfeeding Multimodal analgesic regimen including an intrathecal long-acting opioid, non-steroidal anti-inflammatory drugs, and acetaminophen has been suggested to effectively control postoperative pain after caesarean delivery Intravenous dexamethasone is recommended in elective caesarean delivery to decrease postoperative pain. Several systematic reviews and meta-analyses have examined the efficacy of dexamethasone after caesarean delivery and reported decreased postoperative pain and prolonged time to first analgesia In the same context, a meta-analysis of randomized controlled trials in humans suggests that there may be a benefit to using intrathecal ketamine as an adjunct to bupivacaine to improve postoperative pain after cesarean section . The mechanisms of action of intrathecal ketamine are incompletely understood. One study reports that ketamine's high lipophilicity allows for rapid diffusion into the venous system, namely through the azygos vein.
The following parameters will be monitored intraoperatively every 5 min:
- HR, SBP, DBP, and MAP and SpO2 and documented every 15 min. till the end of surgery.
- Any hemodynamic response to skin incision and to subsequent surgical steps will be documented.
- For maintaining HR or systolic in range of more or less than 20% of baseline intraoperatively, ephedrine and intravenous fluids will be used . No other analgesic will be given intraoperatively.
- primperan 0.1 mg/kg will be given at the end of the procedure to all patients.
- All patients will receive 20 iu of oxytocin more till 40 iu or any ueterotonic drugs ( papal,methylergometrine) if needed .
- Postoperative pain will be assessed using an 11-point (0=no pain and 10=worst pain) numeric rating scale (NRS). NRS for pain at rest and when coughing will be assessed serially at 1, 2, 4, 8, 16 and 24 h after surgery. The assessor and the patients will be unaware of the type of intervention received.
- Time for first analgesic request and NRS at first analgesic request will be recorded. The duration of analgesia will be evaluated as the time from block administration to the time at which patient complained of pain or NRS ≥4 on assessment at serial intervals and nalurphine will be used as rescue analgesia . Total doses of analgesics required in the first 24 h will be recorded.
- The presence of postoperative nausea and vomiting during the first 24 h will be recorded. Postoperative nausea or vomiting will be treated with 0.1 mg/kg of ondansetron. If the patient did not respond to ondansetron, then metoclopramide 10 mg will be given IV. Occurrence of any complications such as sedation ,nystagmus ,dizziness will be assessed
- Conditions
- Post Cesarean Analgesia
- Being tested
- Ketamine, dexamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
. Standard monitoring procedures will include pulse oximetry, electrocardiography, and noninvasive arterial pressure prior to anesthetic induction. All patients will be premedicate antibiotic prophylaxis, according to the hospital's protocol. Anesthesia will be induced with intrathecal bupivacaine 10mg and ,1 mg/kg ketamine added in group A under sterile condition
dexamethasoneDrug
. Standard monitoring procedures will include pulse oximetry, electrocardiography, and noninvasive arterial pressure prior to anesthetic induction. All patients will be premedicate antibiotic prophylaxis, according to the hospital's protocol. Anesthesia will be induced with intrathecal bupivacaine 10mg and iv dexamethasone will be added
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | will include 30 patients, will receive intrathecal bupivacaine 10mg , ,2mg morphine. |
| Ketamine group | Active comparator | will include 30 patients, will receive intrathecal bupivacaine 10 mg , ,2 mg morphine, ,1 mg/kg ketamine . Receives: Drug: Ketamine |
| Dexamethasone group | Active comparator | will include 30 patients , will receive intrathecal bupivacaine 10 mg , ,2 mg morphine , intravenous dexamethasone 8mg . Receives: Drug: dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
first call for analgesia
The first call for analgesia (the elapsed time from the time of spinal anaesthesia until the first postoperative analgesic use after the end of the surgery, which will be administrated based on patient request).
Measured: 24 hours
Secondary outcomes (2)
nausea & vomiting
Incidence of Postoperative nausea \& vomiting (PONV) 24 hours postoperatively.
Measured: 24 hours
analgesic requirement
The total analgesic requirement in 24 hours
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 posted10 May 2024
- Study start1 Dec 2024 (estimated)
- Primary completion15 Dec 2024 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Post Cesarean AnalgesiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rokaya Mahmoud Khalifa, Assiut University
- Investigators
- nagwa mo ibraheem, prof, Principal investigator, assuit study
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06408974
- Sponsor's protocol ID
- comparison
- Status last verified
- May 2024
- First submitted
- 27 Nov 2023
- Last updated
- 10 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gamez BH, Habib AS. Predicting Severity of Acute Pain After Cesarean Delivery: A Narrative Review. Anesth Analg. 2018 May;126(5):1606-1614. doi: 10.1213/ANE.0000000000002658.
PubMed 29210789Bornstein E, Husk G, Lenchner E, Grunebaum A, Gadomski T, Zottola C, Werner S, Hirsch JS, Chervenak FA. Implementation of a Standardized Post-Cesarean Delivery Order Set with Multimodal Combination Analgesia Reduces Inpatient Opioid Usage. J Clin Med. 2020 Dec 22;10(1):7. doi: 10.3390/jcm10010007.
PubMed 33375192Heesen M, Rijs K, Hilber N, Eid K, Al-Oweidi A, Rossaint R, Klimek M. Effect of intravenous dexamethasone on postoperative pain after spinal anaesthesia - a systematic review with meta-analysis and trial sequential analysis. Anaesthesia. 2019 Aug;74(8):1047-1056. doi: 10.1111/anae.14666. Epub 2019 May 6.
PubMed 31058317Sohnen S, Dowling O, Shore-Lesserson L. Single dose perioperative intrathecal ketamine as an adjuvant to intrathecal bupivacaine: A systematic review and meta-analysis of adult human randomized controlled trials. J Clin Anesth. 2021 Oct;73:110331. doi: 10.1016/j.jclinane.2021.110331. Epub 2021 May 5.
PubMed 33962333Bion JF. Intrathecal ketamine for war surgery. A preliminary study under field conditions. Anaesthesia. 1984 Oct;39(10):1023-8. doi: 10.1111/j.1365-2044.1984.tb08895.x.
PubMed 6496899Ituk U, Thenuwara K. The effect of a single intraoperative dose of intravenous dexamethasone 8 mg on post-cesarean delivery analgesia: a randomized controlled trial. Int J Obstet Anesth. 2018 Aug;35:57-63. doi: 10.1016/j.ijoa.2018.03.008. Epub 2018 Mar 26.
PubMed 29773484
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Of Intrathecal Ketamine Versus Intravenous Dexamethasone For Postoperative Analgesia In Parturients Undergoing Spinal Anaesthesia For Cesarean Section: A Randomised Trial
- ClinicalTrials.gov ID
- NCT06408974
- Acronym / sponsor ID
- comparison
- Conditions
- Post Cesarean Analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 10 May 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.
The aim of our study is to compare the postoperative analgesic efficacy of intrathecal ketamine added to bupivacaine to that of intravenous dexamethasone in patients undergoing cesarean section under bupivacaine spinal anesthesia.
Detailed description
Caesarean delivery is associated with postoperative pain that may influence recovery, psychological maternal well-being, and breastfeeding Multimodal analgesic regimen including an intrathecal long-acting opioid, non-steroidal anti-inflammatory drugs, and acetaminophen has been suggested to effectively control postoperative pain after caesarean delivery Intravenous dexamethasone is recommended in elective caesarean delivery to decrease postoperative pain. Several systematic reviews and meta-analyses have examined the efficacy of dexamethasone after caesarean delivery and reported decreased postoperative pain and prolonged time to first analgesia In the same context, a meta-analysis of randomized controlled trials in humans suggests that there may be a benefit to using intrathecal ketamine as an adjunct to bupivacaine to improve postoperative pain after cesarean section . The mechanisms of action of intrathecal ketamine are incompletely understood. One study reports that ketamine's high lipophilicity allows for rapid diffusion into the venous system, namely through the azygos vein.
The following parameters will be monitored intraoperatively every 5 min:
- HR, SBP, DBP, and MAP and SpO2 and documented every 15 min. till the end of surgery.
- Any hemodynamic response to skin incision and to subsequent surgical steps will be documented.
- For maintaining HR or systolic in range of more or less than 20% of baseline intraoperatively, ephedrine and intravenous fluids will be used . No other analgesic will be given intraoperatively.
- primperan 0.1 mg/kg will be given at the end of the procedure to all patients.
- All patients will receive 20 iu of oxytocin more till 40 iu or any ueterotonic drugs ( papal,methylergometrine) if needed .
- Postoperative pain will be assessed using an 11-point (0=no pain and 10=worst pain) numeric rating scale (NRS). NRS for pain at rest and when coughing will be assessed serially at 1, 2, 4, 8, 16 and 24 h after surgery. The assessor and the patients will be unaware of the type of intervention received.
- Time for first analgesic request and NRS at first analgesic request will be recorded. The duration of analgesia will be evaluated as the time from block administration to the time at which patient complained of pain or NRS ≥4 on assessment at serial intervals and nalurphine will be used as rescue analgesia . Total doses of analgesics required in the first 24 h will be recorded.
- The presence of postoperative nausea and vomiting during the first 24 h will be recorded. Postoperative nausea or vomiting will be treated with 0.1 mg/kg of ondansetron. If the patient did not respond to ondansetron, then metoclopramide 10 mg will be given IV. Occurrence of any complications such as sedation ,nystagmus ,dizziness will be assessed
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –will include 30 patients, will receive intrathecal bupivacaine 10mg , ,2mg morphine. |
| Ketamine group | Active comparator | Drug: Ketaminewill include 30 patients, will receive intrathecal bupivacaine 10 mg , ,2 mg morphine, ,1 mg/kg ketamine . |
| Dexamethasone group | Active comparator | Drug: dexamethasonewill include 30 patients , will receive intrathecal bupivacaine 10 mg , ,2 mg morphine , intravenous dexamethasone 8mg . |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 18 and 45 years
- Body mass index (BMI) of 18-35 kg/m2
- Patients with the American Society of Anesthesiologists (ASA) physical status I/II,
- Patients scheduled for elective cesarean section .
- females. .
Key exclusion criteria (7 listed)
- Patient refusal
- Allergy to local anaesthetics
- Infection at the site of injection
- Coagulopathy,
- Chronic pain syndromes
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 |
|---|---|---|
| Ketamine. Standard monitoring procedures will include pulse oximetry, electrocardiography, and noninvasive arterial pressure prior to anesthetic induction. All patients will be premedicate antibiotic prophylaxis, according to the hospital's protocol. Anesthesia will be induced with intrathecal bupivacaine 10mg and ,1 mg/kg ketamine added in group A under sterile condition | Drug | Ketamine group |
| dexamethasone. Standard monitoring procedures will include pulse oximetry, electrocardiography, and noninvasive arterial pressure prior to anesthetic induction. All patients will be premedicate antibiotic prophylaxis, according to the hospital's protocol. Anesthesia will be induced with intrathecal bupivacaine 10mg and iv dexamethasone will be added | Drug | Dexamethasone group |
Primary outcome
first call for analgesia
Time frame: 24 hours
The first call for analgesia (the elapsed time from the time of spinal anaesthesia until the first postoperative analgesic use after the end of the surgery, which will be administrated based on patient request).
2 secondary outcomes
nausea & vomiting
Time frame: 24 hours
analgesic requirement
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Results publication: PubMed 29210789Gamez BH, Habib AS. Predicting Severity of Acute Pain After Cesarean Delivery: A Narrative Review. Anesth Analg. 2018 May;126(5):1606-1614. doi: 10.1213/ANE.0000000000002658.
- Results publication: PubMed 33375192Bornstein E, Husk G, Lenchner E, Grunebaum A, Gadomski T, Zottola C, Werner S, Hirsch JS, Chervenak FA. Implementation of a Standardized Post-Cesarean Delivery Order Set with Multimodal Combination Analgesia Reduces Inpatient Opioid Usage. J Clin Med. 2020 Dec 22;10(1):7. doi: 10.3390/jcm10010007.
- Results publication: PubMed 31058317Heesen M, Rijs K, Hilber N, Eid K, Al-Oweidi A, Rossaint R, Klimek M. Effect of intravenous dexamethasone on postoperative pain after spinal anaesthesia - a systematic review with meta-analysis and trial sequential analysis. Anaesthesia. 2019 Aug;74(8):1047-1056. doi: 10.1111/anae.14666. Epub 2019 May 6.
- Results publication: PubMed 33962333Sohnen S, Dowling O, Shore-Lesserson L. Single dose perioperative intrathecal ketamine as an adjuvant to intrathecal bupivacaine: A systematic review and meta-analysis of adult human randomized controlled trials. J Clin Anesth. 2021 Oct;73:110331. doi: 10.1016/j.jclinane.2021.110331. Epub 2021 May 5.
- Results publication: PubMed 6496899Bion JF. Intrathecal ketamine for war surgery. A preliminary study under field conditions. Anaesthesia. 1984 Oct;39(10):1023-8. doi: 10.1111/j.1365-2044.1984.tb08895.x.
- Results publication: PubMed 29773484Ituk U, Thenuwara K. The effect of a single intraoperative dose of intravenous dexamethasone 8 mg on post-cesarean delivery analgesia: a randomized controlled trial. Int J Obstet Anesth. 2018 Aug;35:57-63. doi: 10.1016/j.ijoa.2018.03.008. Epub 2018 Mar 26.
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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.
nagwa mo ibraheem, prof principal investigator
assuit study
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine and dexamethasone in people with Post Cesarean Analgesia, 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 5 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: status not confirmed, as of the sponsor's last update on 10 May 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact rokaya ma khalifa, resident (01013940535, Rokayakhalifa495@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
first call for analgesia (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 NCT06408974, which also lists 6 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 10 May 2024.