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Completed

NCT Number: NCT01425658

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Qazvin university of medical science

Qazvin, Qazvin Province, 34197/59811, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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. -

Treatment and study plan

distilled water

Drug

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

Clonidine

Drug

The clonidine group (group C) received bupivacaine 10mg combined with 75 microgram clonidine intrathecally .

Fentanyl

Drug

The Fentanyl group (group F) received bupivacaine 10mg combined with 25 microgram fentanyl intrathecally .

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. 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

    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

  2. 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 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

  3. the onset of motor block will be assessed by the modified Bromage score

    Time frame: every10 seconds following intrathecal injection

    The onset of motor block was defined as the time between the end of injection of the intrathecal anesthetic to Bromage block 1

  4. duration of motor block will be assessed by the modified Bromage score

    Time frame: every 5 minutes following intrathecal injection

    duration of motor block was defined the time from intrathecal injection to Bromage score0

Sponsors and collaborators

Lead sponsor

Qazvin University Of Medical Sciences

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 30, 2011
Registry last updated
May 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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