intrathecaم Ketamine, Morphine and Both for Lower Abdominal Cancer Surgery Pain

Effects of Intrathecally Administered Ketamine, Morphine and Their Combination in Patients Undergoing Major Abdominal Cancer Surgery

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: intrathecal morphine; Drug: intrathecal ketamine; Drug: intrathecal morphine + ketamine

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group I: morphine group; patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.3 mg morphine in 1 ml volume intrathecally.	Drug: intrathecal morphine; patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.3 mg intrathecal morphine1 ml volume.
Active Comparator: group II: ketamine group; patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.1 mg/kg ketamine in 1ml volume intrathecally.	Drug: intrathecal ketamine; patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.1 mg/kg intrathecal ketamine in 1ml volume.
Active Comparator: group III: morphine + ketamine group; 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.	Drug: intrathecal morphine + ketamine; patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and intrathecal morphine + ketamine 0.3 mg and 0.1 mg/kg respectively in 1 ml volume.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS) scores	postoperative pain measured by this score.	24 hours postoperative
time to first analgesic request	the time passed till the first request of rescue analgesia by the patients	24 hours postoperative
total analgesic consumption	the total amount of rescue analgesic drug used allover follow up period	24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
side effects	the type and rate of incidence of side effects during the follow up period	24 hours postoperative

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: March 30, 2016
• First Submitted That Met QC Criteria: March 30, 2016
• First Posted (Estimate): April 4, 2016

Study Record Updates

• Last Update Posted (Estimate): January 26, 2017
• Last Update Submitted That Met QC Criteria: January 25, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Opioid; Narcotics; Ketamine; Morphine
• Other Study ID Numbers: 165

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided