Comparison of Postoperative Analgesic Effect of Intrathecal Clonidine and Fentanyl Added to Bupivacaine in Patients Undergoing Cesarean Section
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Objective :To compare the analgesic effect of intrathecal clonidine and fentanyl 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 clonidine group (groupC) received bupivacaine 10mg combined with 75microgram clonidine preservative free ,the fentanyl group (group F) received bupivacaine 10mg combined with25microgram fentanyl 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Post Operative Pain |
Drug: distilled water Drug: Clonidine Drug: Fentanyl |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
- 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. ] [ Designated as safety issue: Yes ]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) ] [ Designated as safety issue: Yes ]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)
- 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 ] [ Designated as safety issue: Yes ]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
- 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 ] [ Designated as safety issue: Yes ]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
- the onset of motor block will be assessed by the modified Bromage score [ Time Frame: every10 seconds following intrathecal injection ] [ Designated as safety issue: Yes ]The onset of motor block was defined as the time between the end of injection of the intrathecal anesthetic to Bromage block 1
- duration of motor block will be assessed by the modified Bromage score [ Time Frame: every 5 minutes following intrathecal injection ] [ Designated as safety issue: Yes ]duration of motor block was defined the time from intrathecal injection to Bromage score0
| Enrollment: | 90 |
| Study Start Date: | August 2011 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: clonidine
The clonidine group (groupC) received bupivacaine 10mg combined with 75 microgram clonidine preservative free intrathecally
|
Drug: Clonidine
The clonidine group (group C) received bupivacaine 10mg combined with 75 microgram clonidine intrathecally .
|
|
Active Comparator: Fentanyl
The fentanyl group (groupF) received bupivacaine 10mg combined with 25 microgram clonidine preservative free intrathecally
|
Drug: Fentanyl
The Fentanyl group (group F) received bupivacaine 10mg combined with 25 microgram fentanyl intrathecally .
|
|
Placebo Comparator: distilled water
The placebo group (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally .
|
Drug: distilled water
The placebo group (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally .
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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. -
Contacts and Locations More Information
No publications provided
| Responsible Party: | marzieh beigom khezri, Assistant professor, Qazvin University Of Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT01425658 History of Changes |
| Other Study ID Numbers: | ACTRN12611000909921 |
| Study First Received: | August 28, 2011 |
| Last Updated: | May 16, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Qazvin University Of Medical Sciences:
|
Fentanyl clonidine intrathcal bupivacaine |
Additional relevant MeSH terms:
|
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Signs and Symptoms Bupivacaine Fentanyl Clonidine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents |
Central Nervous System Agents Therapeutic Uses Antihypertensive Agents Cardiovascular Agents Sympatholytics Autonomic Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics Adjuvants, Anesthesia Narcotics |
ClinicalTrials.gov processed this record on May 22, 2013