Combined Intrathecal Morphine and Dexmedetomidine Analgesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-03-31

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.

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intrathecal Bupivacaine

intrathecal injection of 10 mg hyperbaric bupivacaine 0.5% in 2 ml volume and 1ml of saline 0.9%

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

intrathecal 10 mg bupivacaine

Intrathecal Morphine

intrathecal injection of 10mg bupivacaine 0.5% in 2ml volume intrathecal injection of 0.5 mg morphine in 1ml volume

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

intrathecal 10 mg bupivacaine

Morphine

Intervention Type DRUG

intrathecal 0.5mg morphine

Intrathecal Morphine-Dex

intrathecal 10mg bupivacaine 0.5% in 2 ml volume intrathecal 0.5 mg morphine intrathecal 5 µg of dexmedetomidine in 1ml volume .

Group Type ACTIVE_COMPARATOR

Dexmedetomidine (Precedex)

Intervention Type DRUG

intrathecal administration

Bupivacaine

Intervention Type DRUG

intrathecal 10 mg bupivacaine

Morphine

Intervention Type DRUG

intrathecal 0.5mg morphine

Interventions

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Dexmedetomidine (Precedex)

intrathecal administration

Intervention Type DRUG

Bupivacaine

intrathecal 10 mg bupivacaine

Intervention Type DRUG

Morphine

intrathecal 0.5mg morphine

Intervention Type DRUG

Other Intervention Names

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Precedex Buvicaine morphine sulphate

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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No