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

NCT02726828 | Completed Phase 2 DMC

• 1 other identifier: 165
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• side effects

  24 hours postoperative

Study Arms (3)

group I: morphine group

ACTIVE COMPARATOR

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

group II: ketamine group

ACTIVE COMPARATOR

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

group III: morphine + ketamine group

ACTIVE COMPARATOR

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

Interventions

intrathecal morphine DRUG

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

group I: morphine group

intrathecal ketamine 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 II: ketamine group

intrathecal morphine + ketamine 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.

group III: morphine + ketamine group

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesia (ASA) I-III patients.
• aged 30-50 years.
• scheduled for major abdominal cancer surgery.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia, icu, and pain management

Study Record Dates

• First Submitted: March 30, 2016
• First Posted: April 4, 2016
• Study Start: October 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: April 1, 2016
• Last Updated: January 26, 2017

Record last verified: 2017-01