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

Sponsor

Assiut University (Other)

Overall Status

Completed

CT.gov ID

NCT02726828

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: intrathecal morphine Drug: intrathecal ketamine Drug: intrathecal morphine + ketamine	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2015

Actual Primary Completion Date :

Feb 1, 2016

Actual Study Completion Date :

Apr 1, 2016

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

side effects [24 hours postoperative]
the type and rate of incidence of side effects during the follow up period

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmad Mohammad Abd El-Rahman, Lecturer of anesthesia, icu, and pain management, Assiut University

ClinicalTrials.gov Identifier:

NCT02726828

Other Study ID Numbers:

First Posted:

Apr 4, 2016

Last Update Posted:

Jan 26, 2017

Last Verified:

Jan 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Additional relevant MeSH terms:

Pain, Postoperative

Ketamine

Morphine

Study Results

No Results Posted as of Jan 26, 2017