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

Phase 2

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: intrathecal morphine + ketamine; Drug: intrathecal morphine; Drug: intrathecal ketamine

• Registration Number: NCT02726828
• Lead Sponsor: Assiut University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Primary Completion: 2016-02
• Study First Submitted: 2016-03-30
• Study First Submitted QC: 2016-03-30
• Study Completion: 2016-04
• Study First Posted: 2016-04-04
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-25
• Last Update Posted: 2017-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
group III: morphine + ketamine group	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.
group I: morphine group	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.
group II: ketamine group	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
side effects	24 hours postoperative	the type and rate of incidence of side effects during the follow up period