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

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02726828
Enrollment
90
Registered
2016-04-04
Start date
2015-10-31
Completion date
2016-04-30
Last updated
2017-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

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.

Interventions

DRUGintrathecal morphine

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

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

DRUGintrathecal 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.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Visual Analogue Scale (VAS) scores24 hours postoperativepostoperative pain measured by this score.
time to first analgesic request24 hours postoperativethe time passed till the first request of rescue analgesia by the patients
total analgesic consumption24 hours postoperativethe total amount of rescue analgesic drug used allover follow up period

Secondary

MeasureTime frameDescription
side effects24 hours postoperativethe type and rate of incidence of side effects during the follow up period

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026