Post Operative PainPhase 1/2NCT01404442
Evaluation of the Analgesic Effect of Midazolam and Ketamine as an Additive to Intrathecal Bupivacaine in Patients Undergoing Cesarean Section
A Phase 1/2 study testing Ketamine and Midazolam in people with Post Operative Pain, run by Qazvin University Of Medical Sciences at 1 site in Iran.
Trial summary
Objective :To compare the analgesic effect of intrathecal midazolam and ketamine as an additive to bupivacaine in patients undergoing cesarean section . Methods:Following Ethics Committee approval and informed patients consent, Ninety patients 18-45 yr old ASA physical status I or II, scheduled for cesarean section… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Ketamine and Midazolam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteIran
- Study dates
- May 2011to Dec 2011
- Phase
- Phase 1/2
- 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
- No healthy volunteers
- Adult
Who may be able to join
- patients with American Society of Anesthesiologists(ASA) physical status I and II, undergoing elective cesarean section
Who cannot join
- significant coexisting disease such as hepato-renal and cardiovascular disease
- any contraindication to regional anesthesia such as local infection or bleeding disorders
- allergy to ketamine or midazolam
- long-term opioid use or a history of chronic pain.
Trial locations and contacts
1 site in 1 country.
About this study
Objective :To compare the analgesic effect of intrathecal midazolam and ketamine as an additive to bupivacaine in patients undergoing cesarean section .
Methods:Following Ethics Committee approval and informed patients consent, Ninety patients 18-45 yr old ASA physical status I or II, scheduled for cesarean section under spinal anesthesia, were studied in a prospective, double-blinded, randomized way. The patients were randomly allocated to one of three groups of 30 each. The ketamine group (groupK) received bupivacaine 10mg combined with 0.1 mg/kg ketamine preservative free ,the midazolam group (group M) received bupivacaine 10mg combined with0.02 mg/ kg midazolam and the placebo group (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally . Time to first requirement of analgesic supplement, Sensory block onset time, maximum sensory level , onset of motor block, duration of blockade, hemodynamics variables, the incidence of hypotension, ephedrine requirements, bradycardia ,hypoxemia [Saturation of peripheral oxygen (SpO2)<90], postoperative analgesic requirements and Adverse events, such as sedation, dizziness , Pruritus and postoperative nausea and vomiting were recorded. Patients were instructed preoperatively in the use of the verbal rating scale (VRS) from 0 to 10 (0no pain, 10maximum imaginable pain) for pain assessment. If the VRS exceeded four and the patient requested a supplement analgesic, diclofenac Na supp 100 mg was to be given for post-operative pain relief as needed . For breakthrough pain(VRS >4) if time of administration of diclofenac Na less than 8h,Pethidine 25 mg IV was given.
Read the detailed description
The patients were randomly allocated to one of three groups of 30 each. The ketamine group (groupK) received bupivacaine 10mg combined with 0.1 mg/kg ketamine preservative free ,the midazolam group (group M) received bupivacaine 10mg combined with0.02 mg/ kg midazolam and the placebo group (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally .
- Conditions
- Post Operative Pain
- Keywords
- midazolam, ketamine, intrathecal, pain
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placebo(distilled waterDrug
The placebo group (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally .
KetamineDrug
The ketamine group (groupK) received bupivacaine 10mg combined with 0.1 mg/kg ketamine preservative free intrathecally
MidazolamDrug
The midazolam group (group M) received bupivacaine 10mg combined with0.02 mg/ kg midazolam intrathecally
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Active comparator | The ketamine group (groupK) received bupivacaine 10mg combined with 0.1 mg/kg ketamine preservative free intrathecally . Receives: Drug: Ketamine |
| midazolam | Active comparator | The midazolam group (group M) received bupivacaine 10mg combined with0.02 mg/ kg midazolam intrathecally Receives: Drug: Midazolam |
| placebo | Placebo comparator | The placebo group (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally . Receives: Drug: placebo(distilled water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first requirement of analgesic supplement
analgesic administration was initiated by patient request(verbal rating scale[ VRS]>4)
Measured: participants will be followed for the duration of 24 hours after intratechal injection (Time from the injection of intrathecal anesthetic solution to first requirement of analgesic supplement will be recorded.)
Postoperative analgesic requirements
postoperative analgesic requirements will be assessed by verbal rating scale (VRS) from 0 to 10 (0no pain, 10maximum imaginable pain).Each administration was initiated by patient request( VRS>4)
Measured: 24 hours postoperative(Time from the injection of intrathecal anesthetic solution to 24 hours postoperative)
Secondary outcomes (14)
Sensory block onset time will be assessed by a pinprick test
The onset of sensory block was defined as the time between the end of injection of the intrathecal anesthetic and the absence of pain at the T10 dermatome
Measured: sensory block will be assessed by pinprick test every 10 seconds following intrathecal injection
duration of sensory block will be assessed by a pinprick test
The duration of sensory block was defined as the time for regression from the maximum block height sensory block to T10 dermatom will be assessed by pinprick test every 5 minuts following intrathecal injection
Measured: sensory block will be assessed by pinprick test every 5 minuts following intrathecal injection
the onset of motor block will be assessed by the modified Bromage score
The onset of motor block was defined as the time between the end of injection of the intrathecal anesthetic to Bromage block 1
Measured: every10 seconds following intrathecal injection
hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Measured: 5min before the intrathecal injection
hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Measured: 2minutes after intrathecal injection
hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Measured: 4minutes after intrathecal injection
hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Measured: 6minutes after intrathecal injection
hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Measured: 8minutes after intrathecal injection
hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Measured: 10 minutes after intrathecal injection
hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Measured: 15minutes after intrathecal injection
hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Measured: 20 minutes after intrathecal injection
hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Measured: 25 minutes after intrathecal injection
hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Measured: 30 minutes after intrathecal injection
duration of motor block will be assessed by the modified Bromage score
duration of motor block was defined the time from intrathecal injection to Bromage score0
Measured: every 5 minutes following intrathecal injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2011 (estimated)
- Study startMay 2011
- Primary completionNov 2011
- Study completionDec 2011
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 Post Operative PainStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qazvin University Of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, marzieh beigom khezri, Qazvin University Of Medical Sciences
- Investigators
- Marzieh Beigom Khezri, Principal investigator, Qazvin medical science university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01404442
- Sponsor's protocol ID
- ACTRN12611000729921
- Status last verified
- May 2012
- First submitted
- 21 Jul 2011
- Last updated
- 17 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Khezri MB, Ghasemi J, Mohammadi N. Evaluation of the analgesic effect of ketamine as an additive to intrathecal bupivacaine in patients undergoing cesarean section. Acta Anaesthesiol Taiwan. 2013 Dec;51(4):155-60. doi: 10.1016/j.aat.2013.12.004. Epub 2014 Jan 21.
PubMed 24529671
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Analgesic Effect of Midazolam and Ketamine as an Additive to Intrathecal Bupivacaine in Patients Undergoing Cesarean Section
- ClinicalTrials.gov ID
- NCT01404442
- Acronym / sponsor ID
- ACTRN12611000729921
- Conditions
- Post Operative Pain
- Keywords
- midazolam, ketamine, intrathecal, pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Qazvin University Of Medical SciencesUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 28 Jul 2011 (estimated)
- 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.
Objective :To compare the analgesic effect of intrathecal midazolam and ketamine as an additive to bupivacaine in patients undergoing cesarean section .
Methods:Following Ethics Committee approval and informed patients consent, Ninety patients 18-45 yr old ASA physical status I or II, scheduled for cesarean section under spinal anesthesia, were studied in a prospective, double-blinded, randomized way. The patients were randomly allocated to one of three groups of 30 each. The ketamine group (groupK) received bupivacaine 10mg combined with 0.1 mg/kg ketamine preservative free ,the midazolam group (group M) received bupivacaine 10mg combined with0.02 mg/ kg midazolam and the placebo group (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally . Time to first requirement of analgesic supplement, Sensory block onset time, maximum sensory level , onset of motor block, duration of blockade, hemodynamics variables, the incidence of hypotension, ephedrine requirements, bradycardia ,hypoxemia [Saturation of peripheral oxygen (SpO2)<90], postoperative analgesic requirements and Adverse events, such as sedation, dizziness , Pruritus and postoperative nausea and vomiting were recorded. Patients were instructed preoperatively in the use of the verbal rating scale (VRS) from 0 to 10 (0no pain, 10maximum imaginable pain) for pain assessment. If the VRS exceeded four and the patient requested a supplement analgesic, diclofenac Na supp 100 mg was to be given for post-operative pain relief as needed . For breakthrough pain(VRS >4) if time of administration of diclofenac Na less than 8h,Pethidine 25 mg IV was given.
Detailed description
The patients were randomly allocated to one of three groups of 30 each. The ketamine group (groupK) received bupivacaine 10mg combined with 0.1 mg/kg ketamine preservative free ,the midazolam group (group M) received bupivacaine 10mg combined with0.02 mg/ kg midazolam and the placebo group (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Active comparator | Drug: KetamineThe ketamine group (groupK) received bupivacaine 10mg combined with 0.1 mg/kg ketamine preservative free intrathecally . |
| midazolam | Active comparator | Drug: MidazolamThe midazolam group (group M) received bupivacaine 10mg combined with0.02 mg/ kg midazolam intrathecally |
| placebo | Placebo comparator | Drug: placebo(distilled waterThe placebo group (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally . |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with American Society of Anesthesiologists(ASA) physical status I and II, undergoing elective cesarean section
Key exclusion criteria (4 listed)
- significant coexisting disease such as hepato-renal and cardiovascular disease
- any contraindication to regional anesthesia such as local infection or bleeding disorders
- allergy to ketamine or midazolam
- long-term opioid use or a history of chronic pain.
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 |
|---|---|---|
| placebo(distilled waterThe placebo group (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally . | Drug | placebo |
| KetamineThe ketamine group (groupK) received bupivacaine 10mg combined with 0.1 mg/kg ketamine preservative free intrathecally | Drug | Ketamine |
| MidazolamThe midazolam group (group M) received bupivacaine 10mg combined with0.02 mg/ kg midazolam intrathecally | Drug | midazolam |
Primary outcome
Time to first requirement of analgesic supplement
Time frame: participants will be followed for the duration of 24 hours after intratechal injection (Time from the injection of intrathecal anesthetic solution to first requirement of analgesic supplement will be recorded.)
analgesic administration was initiated by patient request(verbal rating scale[ VRS]>4)
Postoperative analgesic requirements
Time frame: 24 hours postoperative(Time from the injection of intrathecal anesthetic solution to 24 hours postoperative)
postoperative analgesic requirements will be assessed by verbal rating scale (VRS) from 0 to 10 (0no pain, 10maximum imaginable pain).Each administration was initiated by patient request( VRS>4)
14 secondary outcomes
Sensory block onset time will be assessed by a pinprick test
Time frame: sensory block will be assessed by pinprick test every 10 seconds following intrathecal injection
duration of sensory block will be assessed by a pinprick test
Time frame: sensory block will be assessed by pinprick test every 5 minuts following intrathecal injection
the onset of motor block will be assessed by the modified Bromage score
Time frame: every10 seconds following intrathecal injection
hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Time frame: 5min before the intrathecal injection
hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Time frame: 2minutes after intrathecal injection
hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Time frame: 4minutes after intrathecal injection
hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Time frame: 6minutes after intrathecal injection
hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Time frame: 8minutes after intrathecal injection
hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Time frame: 10 minutes after intrathecal injection
hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Time frame: 15minutes after intrathecal injection
hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Time frame: 20 minutes after intrathecal injection
hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Time frame: 25 minutes after intrathecal injection
hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Time frame: 30 minutes after intrathecal injection
duration of motor block will be assessed by the modified Bromage score
Time frame: every 5 minutes following intrathecal injection
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 17 May 2012.
- Derived from this study: PubMed 24529671Khezri MB, Ghasemi J, Mohammadi N. Evaluation of the analgesic effect of ketamine as an additive to intrathecal bupivacaine in patients undergoing cesarean section. Acta Anaesthesiol Taiwan. 2013 Dec;51(4):155-60. doi: 10.1016/j.aat.2013.12.004. Epub 2014 Jan 21.
Related trials for Post Operative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Marzieh Beigom Khezri principal investigator
Qazvin medical science university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ketamine and Midazolam in people with Post Operative Pain, run by Qazvin University Of Medical Sciences at 1 site in Iran.
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 17 May 2012. 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 Iran. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 first requirement of analgesic supplement (time frame: participants will be followed for the duration of 24 hours after intratechal injection (Time from the injection of intrathecal anesthetic solution to first requirement of analgesic supplement will be recorded.)). The study lists 2 primary outcomes in all. 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 NCT01404442, 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 17 May 2012.