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Combined Intrathecal Morphine and Dexmedetomidine Analgesia

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02435537
Acronym
ITMandDEX
Enrollment
90
Registered
2015-05-06
Start date
2013-05-31
Completion date
2015-03-31
Last updated
2015-05-06

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

Conditions

Postoperative Pain

Keywords

analgesia, intrathecal, opioids, morphine, dexmedetomidine

Brief summary

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

Detailed description

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.

Interventions

DRUGBupivacaine

intrathecal 10 mg bupivacaine

DRUGMorphine

intrathecal 0.5mg morphine

intrathecal administration

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
total dose of intravenous PCA morphine consumption in the first 48 h postoperative48 hoursCalculating the cumulative intravenous PCA morphine dose

Secondary

MeasureTime frameDescription
Noninvasive blood pressure48 hoursnon invasive systolic and diastolic blood pressure intra-operative and postoperative in the 6th, 12th, 18th, 24th, 36th, and 48th h postoperative.
Heart rate48 hoursnon invasive assessment of heart rate in the 6th, 12th, 18th, 24th, 36th, and 48th postoperative. intraoperative and postoperative
peripheral arterial oxygen saturation48 hoursassessment of pulse oximetry intraoperative and in the 6th, 12th, 18th, 24th, 36th, and 48th h postoperative
postoperative VAS scores48 hoursassessment of pain scores on admission to surgical intensive care unit and in the 6th, 12th, 18th, 24th, 36th, and 48th h postoperative.
time to first request for analgesia48hoursmeasuring the time in hours of first request for intravenous PCA morphine

Outcome results

None listed

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