Combined Intrathecal Morphine and Dexmedetomidine Analgesia

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

Detailed Description
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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.

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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Dexmedetomidine (Precedex)
* Drug: Bupivacaine
* Drug: Morphine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intrathecal Bupivacaine<br>intrathecal injection of 10 mg hyperbaric bupivacaine 0.5% in 2 ml volume and 1ml of saline 0.9% | Drug: Bupivacaine<br>* intrathecal 10 mg bupivacaine<br>* Other names: Buvicaine;|
| Active Comparator: Intrathecal Morphine<br>intrathecal injection of 10mg bupivacaine 0.5% in 2ml volume intrathecal injection of 0.5 mg morphine in 1ml volume | Drug: Bupivacaine<br>* intrathecal 10 mg bupivacaine<br>* Other names: Buvicaine;Drug: Morphine<br>* intrathecal 0.5mg morphine<br>* Other names: morphine sulphate;|
| Active Comparator: Intrathecal Morphine-Dex<br>intrathecal 10mg bupivacaine 0.5% in 2 ml volume intrathecal 0.5 mg morphine intrathecal 5 µg of dexmedetomidine in 1ml volume . | Drug: Dexmedetomidine (Precedex)<br>* intrathecal administration<br>* Other names: Precedex;Drug: Bupivacaine<br>* intrathecal 10 mg bupivacaine<br>* Other names: Buvicaine;Drug: Morphine<br>* intrathecal 0.5mg morphine<br>* Other names: morphine sulphate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total dose of intravenous PCA morphine consumption in the first 48 h postoperative | Calculating the cumulative intravenous PCA morphine dose | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Noninvasive blood pressure | non invasive systolic and diastolic blood pressure intra-operative and postoperative in the 6th, 12th, 18th, 24th, 36th, and 48th h postoperative. | 48 hours | 
| Heart rate | non invasive assessment of heart rate in the 6th, 12th, 18th, 24th, 36th, and 48th postoperative. intraoperative and postoperative | 48 hours | 
| peripheral arterial oxygen saturation | assessment of pulse oximetry intraoperative and in the 6th, 12th, 18th, 24th, 36th, and 48th h postoperative | 48 hours | 
| postoperative VAS scores | assessment of pain scores on admission to surgical intensive care unit and in the 6th, 12th, 18th, 24th, 36th, and 48th h postoperative. | 48 hours | 
| time to first request for analgesia | measuring the time in hours of first request for intravenous PCA morphine | 48hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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analgesia, intrathecal, opioids, morphine, dexmedetomidine