Overview

This trial is active, not recruiting.

Condition postoperative pain
Treatments intrathecal morphine, intrathecal ketamine, intrathecal morphine + ketamine
Phase phase 2/phase 3
Sponsor Assiut University
Start date October 2015
End date February 2016
Trial size 90 participants
Trial identifier NCT02726828, 165

Summary

this study investigates the analgesic efficacy and other possible effects of ketamine, morphine, and both together when administered intrathecally for control of postoperative pain following lower abdominal cancer surgeries.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Active Comparator)
patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.3 mg morphine in 1 ml volume intrathecally.
intrathecal morphine
patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.3 mg morphine in 1 ml volume intrathecally.
(Active Comparator)
patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.1 mg/kg ketamine in 1ml volume intrathecally.
intrathecal ketamine
patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.1 mg/kg ketamine in 1ml volume intrathecally.
(Active Comparator)
patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.3 mg morphine plus 0.1 mg/kg of Ketamine in 1 ml volume intrathecally.
intrathecal morphine + ketamine
patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.3 mg morphine plus 0.1 mg/kg of Ketamine in 1 ml volume intrathecally.

Primary Outcomes

Measure
Visual Analogue Scale (VAS) scores
time frame: 24 hours postoperative
time to first analgesic request
time frame: 24 hours postoperative
total analgesic consumption
time frame: 24 hours postoperative

Secondary Outcomes

Measure
side effects
time frame: 24 hours postoperative

Eligibility Criteria

Male or female participants from 30 years up to 50 years old.

Inclusion Criteria: - American Society of Anesthesia (ASA) I-III patients. - aged 30-50 years. - scheduled for major abdominal cancer surgery. Exclusion Criteria: - Patients with a known allergy to the study drugs. - significant cardiac, respiratory, renal or hepatic disease. - coagulation disorders. - infection at or near the site of intrathecal injection. - drug or alcohol abuse. - BMI > 30 kg/m2. - psychiatric illnesses that may interfere with perception and assessment of pain.

Additional Information

Official title Effects of Intrathecally Administered Ketamine, Morphine and Their Combination in Patients Undergoing Major Abdominal Cancer Surgery
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Assiut University.