RecruitingPhase 2ACTRN12611001109998

Evaluation of the analgesic effects of ketamine and fentanyl as an Additive to Intrathecal bupivacaine in patients undergoing cesarean section

Comparison of Postoperative Analgesic Effect of intrathecal ketamine and fentanyl added to bupivacaine in Patients undergoing cesarean section


Sponsor

Qazvin University of Medical Science.

Enrollment

90 participants

Start Date

May 15, 2011

Study Type

Interventional

Conditions

Summary

Objective :To compare the analgesic effect of intratechal fentanyl 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 fentanyl group (groupF) received bupivacaine 10mg combined with 25 microgram 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.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 45 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing two different pain-relief medications — fentanyl and ketamine — added to spinal anesthesia (an injection in the lower back) for women having a caesarean section. The goal is to find out which combination provides better pain relief after the operation and which has fewer side effects. You may be eligible if: - You are a woman between 18 and 45 years old - You are having a planned (elective) caesarean section - Your overall health is good to moderate (ASA physical status I or II) You may NOT be eligible if: - You have significant heart, liver, or kidney disease - You have a bleeding disorder or other reason you cannot have spinal anesthesia - You have an allergy to ketamine or midazolam - You use opioid pain medications regularly or have a history of chronic pain Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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 Ketamin group (group K) received bupivacaine 10 mg combined with0.1mg/kg ketamine preservative free solution ,The fentanyl group (groupF) received bupivacaine 10mg combined with25microgramg fentanyl 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)


Locations(1)

Qazvin, Iran, Islamic Republic Of

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ACTRN12611001109998


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