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Comparison of Postoperative Analgesic Effect of Intrathecal Clonidine and Fentanyl Added to Bupivacaine in Patients Undergoing Cesarean Section

Primary Purpose

Post Operative Pain

Status
Completed
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
distilled water
Clonidine
Fentanyl
Sponsored by
Qazvin University Of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Operative Pain focused on measuring Fentanyl, clonidine, intrathcal, bupivacaine

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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. -

Sites / Locations

  • Qazvin university of medical science

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

clonidine

Fentanyl

distilled water

Arm Description

The clonidine group (groupC) received bupivacaine 10mg combined with 75 microgram clonidine preservative free intrathecally

The fentanyl group (groupF) received bupivacaine 10mg combined with 25 microgram clonidine preservative free intrathecally

The placebo group (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally .

Outcomes

Primary Outcome Measures

Time to first requirement of analgesic supplement
analgesic administration was initiated by patient request(verbal rating scale[ VRS]>4)
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)

Secondary Outcome Measures

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
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
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
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

Full Information

First Posted
August 28, 2011
Last Updated
May 16, 2012
Sponsor
Qazvin University Of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01425658
Brief Title
Comparison of Postoperative Analgesic Effect of Intrathecal Clonidine and Fentanyl Added to Bupivacaine in Patients Undergoing Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qazvin University Of Medical Sciences

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
Fentanyl, clonidine, intrathcal, bupivacaine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
clonidine
Arm Type
Active Comparator
Arm Description
The clonidine group (groupC) received bupivacaine 10mg combined with 75 microgram clonidine preservative free intrathecally
Arm Title
Fentanyl
Arm Type
Active Comparator
Arm Description
The fentanyl group (groupF) received bupivacaine 10mg combined with 25 microgram clonidine preservative free intrathecally
Arm Title
distilled water
Arm Type
Placebo Comparator
Arm Description
The placebo group (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally .
Intervention Type
Drug
Intervention Name(s)
distilled water
Intervention Description
The placebo group (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally .
Intervention Type
Drug
Intervention Name(s)
Clonidine
Intervention Description
The clonidine group (group C) received bupivacaine 10mg combined with 75 microgram clonidine intrathecally .
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
The Fentanyl group (group F) received bupivacaine 10mg combined with 25 microgram fentanyl intrathecally .
Primary Outcome Measure Information:
Title
Time to first requirement of analgesic supplement
Description
analgesic administration was initiated by patient request(verbal rating scale[ VRS]>4)
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.
Title
Postoperative analgesic requirements
Description
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)
Time Frame
24 hours postoperative(Time from the injection of intrathecal anesthetic solution to 24 hours postoperative)
Secondary Outcome Measure Information:
Title
Sensory block onset time will be assessed by a pinprick test
Description
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
Time Frame
sensory block will be assessed by pinprick test every 10 seconds following intrathecal injection
Title
duration of sensory block will be assessed by a pinprick test
Description
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
Time Frame
sensory block will be assessed by pinprick test every 5 minuts following intrathecal injection
Title
the onset of motor block will be assessed by the modified Bromage score
Description
The onset of motor block was defined as the time between the end of injection of the intrathecal anesthetic to Bromage block 1
Time Frame
every10 seconds following intrathecal injection
Title
duration of motor block will be assessed by the modified Bromage score
Description
duration of motor block was defined the time from intrathecal injection to Bromage score0
Time Frame
every 5 minutes following intrathecal injection

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. -
Facility Information:
Facility Name
Qazvin university of medical science
City
Qazvin
ZIP/Postal Code
34197/59811
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
24649361
Citation
Khezri MB, Rezaei M, Delkhosh Reihany M, Haji Seid Javadi E. Comparison of postoperative analgesic effect of intrathecal clonidine and fentanyl added to bupivacaine in patients undergoing cesarean section: a prospective randomized double-blind study. Pain Res Treat. 2014;2014:513628. doi: 10.1155/2014/513628. Epub 2014 Feb 4.
Results Reference
derived

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Comparison of Postoperative Analgesic Effect of Intrathecal Clonidine and Fentanyl Added to Bupivacaine in Patients Undergoing Cesarean Section

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