Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000729921
Ethics application status
Approved
Date submitted
11/07/2011
Date registered
13/07/2011
Date last updated
20/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison of pain relief from three different drug regimes for women undergoing cesarean section
Scientific title
Evaluation of the analgesic effect of Midazolam and ketamine as an Additive to Intrathecal bupivacaine in patients undergoing cesarean section
Secondary ID [1] 262609 0
nil
Universal Trial Number (UTN)
U1111-1122-8744
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post-operative pain in
Patients undergoing cesarean section 268302 0
Condition category
Condition code
Anaesthesiology 268434 268434 0 0
Pain management
Reproductive Health and Childbirth 268446 268446 0 0
Childbirth and postnatal care
Surgery 268447 268447 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ninety patients 18-45 yr old American Society of Anesthesiologists ( 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 10 mg combined with 0.1mg/kg ketamine preservative free solution ,The midazolam group (groupM) 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) for each three groups 5 minutes prior to surgery)
Intervention code [1] 266950 0
Prevention
Intervention code [2] 266951 0
Treatment: Drugs
Comparator / control treatment
The placebo group (group P) received bupivacaine 10mg combined with 0.5ml distilled water
Control group
Placebo

Outcomes
Primary outcome [1] 269184 0
Time to first requirement of analgesic supplement(analgesic administration was initiated by patient request(verbal rating scale[ VRS]>4)
Timepoint [1] 269184 0
Time to first requirement of analgesic supplement from the time of injection intrathecal anesthetic solution
Secondary outcome [1] 279085 0
Sensory block onset time will be assessed by a pinprick test
Timepoint [1] 279085 0
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(sensory block will be assessed by pinprick test every 10 seconds following intrathecal injection
Secondary outcome [2] 279086 0
Duration of sensory block will be assessed by a pinprick test
Timepoint [2] 279086 0
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
Secondary outcome [3] 279087 0
The onset of motor block will be assessed by the modified Bromage score (0, no motor loss; 1, inability to flex the hip; 2, inability to flex the knee; and 3, inability to flex the ankle)
Timepoint [3] 279087 0
The time from intrathecal injection to Bromage1 block 1(motor block will be assessed by pinprick test every 10 seconds following intrathecal injection
Secondary outcome [4] 279088 0
Duration of motor block (the time from intrathecal injection to Bromage score 0) will be assessed by the modified Bromage score (0, no motor loss; 1, inability to flex the hip; 2, inability to flex the knee; and 3, inability to flex the ankle)
Timepoint [4] 279088 0
The time from intrathecal injection to Bromage score 0(motor block will be assessed by the modified Bromage score every 5 minuts following intrathecal injection
Secondary outcome [5] 279089 0
Heart rate is assessed by echocardiogram monitoring
Timepoint [5] 279089 0
5min before the intrathecal injection,and at 2, 4, 6, 10, 15,20 ,25,30 min after the injection
Secondary outcome [6] 279090 0
Mean arterial blood pressure is assessed by nonivasive automatic blood pressure measurement
Timepoint [6] 279090 0
5min before the intrathecal injection,and at 2, 4, 6, , 10, 15,20,25 ,30min after the injection

Eligibility
Key inclusion criteria
patients with American Society of Anesthesiologists(ASA) physical status I and II, undergoing elective cesarean section
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Enrollment is decided and permission of the patient is obtained by the anesthesiologists during preoperative rounding.This is a double blinded clinical trial, with blinding of both the patient and the administrating practitioner to the anaesthetic type. Allocation will be managed by a Resident external to the project. The blinding will occur through use of equal amounts of pretreatment drugs (3ml’s) Each syringe will be labeled A ,B,C according to its contents. . The drug syringes are handed over to anesthesiologists blinded to the patient allocation to carry out the spinal of anesthesia
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization was based on computer-generated codes
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/05/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment outside Australia
Country [1] 3705 0
Iran, Islamic Republic Of
State/province [1] 3705 0
Qazvin

Funding & Sponsors
Funding source category [1] 267420 0
Self funded/Unfunded
Name [1] 267420 0
Marzieh Khezri
Country [1] 267420 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Qazvin Medical Science University
Address
Shahid bahonar,Ave3419759811 Qazvin ,Iran
postal code:34197/59811
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 266472 0
Hospital
Name [1] 266472 0
Kosar Hospital
Address [1] 266472 0
Taleghani street,Qazvin,Iran
postal code:3413996134
Country [1] 266472 0
Iran, Islamic Republic Of
Other collaborator category [1] 252105 0
Individual
Name [1] 252105 0
Javad Ghasemi
Address [1] 252105 0
,Resident of Anesthesiology,Qazvin Medical Science University,shahid bahonar,Ave3419759811 Qazvin ,Iran
postal code:34197/59811,
Country [1] 252105 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269393 0
Qazvin Medical University Science
Ethics committee address [1] 269393 0
shahid bahonar,Ave3419759811 Qazvin ,Iran
postal code:34197/59811
Ethics committee country [1] 269393 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 269393 0
18/08/2010
Approval date [1] 269393 0
23/10/2010
Ethics approval number [1] 269393 0
d/20/1718

Summary
Brief summary
Objective :To compare the analgesic effect of intratechal 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32863 0
Address 32863 0
Country 32863 0
Phone 32863 0
Fax 32863 0
Email 32863 0
Contact person for public queries
Name 16110 0
Marzieh Beigom Khezri
Address 16110 0
Marzieh Beigom Khezri, Department of Anesthesiology ,Qazvin University of Medical Science. Iran ,qazvin-boulvar bahonar
postal code:34188 99578
Country 16110 0
Iran, Islamic Republic Of
Phone 16110 0
+98-281-2222951
Fax 16110 0
+98-281-2236378
Email 16110 0
mkhezri@qums.ac.ir
Contact person for scientific queries
Name 7038 0
Marzieh Beigom Khezri
Address 7038 0
Marzieh Beigom Khezri, Department of Anesthesiology ,Qazvin University of Medical Science. Iran ,qazvin-boulvar bahonar
postal code:34188 99578
Country 7038 0
Iran, Islamic Republic Of
Phone 7038 0
+98-281-2222951
Fax 7038 0
+98-281-2236378
Email 7038 0
mkhezri@qums.ac.ir

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Results publications and other study-related documents

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