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NCT Number: NCT02435537

Combined Intrathecal Morphine and Dexmedetomidine Analgesia

The current study investigated the effect of adding dexmedetomidine to intrathecal morphine for postoperative analgesia in cancer patients undergoing major abdominal surgery.

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Key information

About this study

Opioids, administered intrathecal or epidural, are widely used for postoperative, and chronic nociceptive pain secondary to cancers. Intrathecal injection of morphine to provide postoperative analgesia during the initial 24 h after operation is a widely used technique.The Human studies on the antinociceptive effects of co-administrated intrathecal morphine and dexmedetomidine in postoperative pain are still lacking. In this study, the investigators aimed to compare the synergistic interaction and side-effects of combined intrathecal morphine and dexmedetomidine with either drug alone for postoperative analgesia in cancer patients undergoing major abdominal surgery. Patients were randomly allocated into three groups of 30 patients each to receive either; hyperbaric bupivacaine 0.5% (Group I/Bupivacaine Group), bupivacaine and 0.5 mg morphine (Group II/Morphine Group), bupivacaine and 0.5 mg morphine plus 5 µg of dexmedetomidine (Group III/Morphine-DEX Group). The assigned drugs were dissolved in 1ml physiological saline and administered intrathecal with bupivacaine before induction of general anesthesia.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • major abdominal cancer surgery (e.g. hemi-colectomy or cystectomy)

Exclusion criteria

  • known allergy to study drugs
  • Significant cardiac, respiratory, renal or hepatic disease.
  • 2nd or 3rd degree heart block.
  • Coagulation disorders.
  • Low back pain or other back problems.
  • Drug or alcohol abuse.
  • BMI>30kg\\m2.
  • Psychiatric illnesses that would interfere with perception and assessment of pain.

Treatment and study plan

Dexmedetomidine (Precedex)

Drug

intrathecal administration

Other names: Precedex

Bupivacaine

Drug

intrathecal 10 mg bupivacaine

Other names: Buvicaine

Morphine

Drug

intrathecal 0.5mg morphine

Other names: morphine sulphate

Primary outcomes

  1. total dose of intravenous PCA morphine consumption in the first 48 h postoperative

    Time frame: 48 hours

    Calculating the cumulative intravenous PCA morphine dose

Secondary outcomes

  1. Noninvasive blood pressure

    Time frame: 48 hours

    non invasive systolic and diastolic blood pressure intra-operative and postoperative in the 6th, 12th, 18th, 24th, 36th, and 48th h postoperative.

  2. Heart rate

    Time frame: 48 hours

    non invasive assessment of heart rate in the 6th, 12th, 18th, 24th, 36th, and 48th postoperative. intraoperative and postoperative

  3. peripheral arterial oxygen saturation

    Time frame: 48 hours

    assessment of pulse oximetry intraoperative and in the 6th, 12th, 18th, 24th, 36th, and 48th h postoperative

  4. postoperative VAS scores

    Time frame: 48 hours

    assessment of pain scores on admission to surgical intensive care unit and in the 6th, 12th, 18th, 24th, 36th, and 48th h postoperative.

  5. time to first request for analgesia

    Time frame: 48hours

    measuring the time in hours of first request for intravenous PCA morphine

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Safety and Efficacy of Dexmedetomidine Addition to Intrathecal Morphine for Postoperative Analgesia in Cancer Patients Undergoing Major Abdominal Surgery

Acronym: ITMandDEX

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 6, 2015
Registry last updated
May 6, 2015

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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