Evaluation of the Analgesic Effect of Midazolam and Ketamine as an Additive to Intrathecal Bupivacaine in Patients Undergoing Cesarean Section

Post Operative Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01404442
• Other study ID #: ACTRN12611000729921
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 21, 2011
• Last updated: May 16, 2012
• Start date: May 2011
• Est. completion date: December 2011

Study information

• Verified date: May 2012
• Source: Qazvin University Of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• patients with American Society of Anesthesiologists(ASA) physical status I and II, undergoing elective cesarean section

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• placebo(distilled water
The placebo group (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally .
• Ketamine
The ketamine group (groupK) received bupivacaine 10mg combined with 0.1 mg/kg ketamine preservative free intrathecally
• Midazolam
The midazolam group (group M) received bupivacaine 10mg combined with0.02 mg/ kg midazolam intrathecally

Locations

Country	Name	City	State
Iran, Islamic Republic of	Qazvin university of medical science	Qazvin

Sponsors (1)

Lead Sponsor	Collaborator
Qazvin University Of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first requirement of analgesic supplement	analgesic administration was initiated by patient request(verbal rating scale[ VRS]>4)	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.)	Yes
Primary	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)	24 hours postoperative(Time from the injection of intrathecal anesthetic solution to 24 hours postoperative)	Yes
Secondary	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	sensory block will be assessed by pinprick test every 10 seconds following intrathecal injection	Yes
Secondary	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	sensory block will be assessed by pinprick test every 5 minuts following intrathecal injection	Yes
Secondary	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	every10 seconds following intrathecal injection	Yes
Secondary	hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring		5min before the intrathecal injection	Yes
Secondary	hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring		2minutes after intrathecal injection	Yes
Secondary	hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring		4minutes after intrathecal injection	Yes
Secondary	hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring		6minutes after intrathecal injection	Yes
Secondary	hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring		8minutes after intrathecal injection	Yes
Secondary	hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring		10 minutes after intrathecal injection	Yes
Secondary	hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring		15minutes after intrathecal injection	Yes
Secondary	hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring		20 minutes after intrathecal injection	Yes
Secondary	hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring		25 minutes after intrathecal injection	Yes
Secondary	hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring		30 minutes after intrathecal injection	Yes
Secondary	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	every 5 minutes following intrathecal injection	Yes