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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

intrathecal morphine

Intervention Type DRUG

patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.3 mg intrathecal morphine1 ml volume.

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.

Group Type ACTIVE_COMPARATOR

intrathecal ketamine

Intervention Type DRUG

patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.1 mg/kg intrathecal ketamine in 1ml volume.

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.

Group Type ACTIVE_COMPARATOR

intrathecal morphine + ketamine

Intervention Type DRUG

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.

Interventions

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intrathecal morphine

patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.3 mg intrathecal morphine1 ml volume.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No