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Completed

NCT Number: NCT02726828

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

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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Key information

Conditions

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

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intrathecal morphine

Drug

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

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.

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.

Primary outcomes

  1. Visual Analogue Scale (VAS) scores

    Time frame: 24 hours postoperative

    postoperative pain measured by this score.

  2. time to first analgesic request

    Time frame: 24 hours postoperative

    the time passed till the first request of rescue analgesia by the patients

  3. total analgesic consumption

    Time frame: 24 hours postoperative

    the total amount of rescue analgesic drug used allover follow up period

Secondary outcomes

  1. side effects

    Time frame: 24 hours postoperative

    the type and rate of incidence of side effects during the follow up period

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 4, 2016
Registry last updated
Jan 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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