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

Assiut University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Postoperative Pain

Treatments: Drug: intrathecal morphine + ketamine; Drug: intrathecal ketamine; Drug: intrathecal morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT02726828

165

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 30 to 50 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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90 participants in 3 patient groups

group I: morphine group

Active Comparator group

Description:

patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.3 mg morphine in 1 ml volume intrathecally.

Treatment:

Drug: intrathecal morphine

group II: ketamine group

Active Comparator group

Description:

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

Treatment:

Drug: intrathecal ketamine

group III: morphine + ketamine group

Active Comparator group

Description:

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.

Treatment:

Drug: intrathecal morphine + ketamine