Combined Intrathecal Morphine and Dexmedetomidine Analgesia (ITMandDEX)

Assiut University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Postoperative Pain

Treatments: Drug: Morphine; Drug: Dexmedetomidine (Precedex); Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02435537

IORG0006563/reference. no. 64

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups

Intrathecal Bupivacaine

Active Comparator group

Description:

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

Treatment:

Drug: Bupivacaine

Intrathecal Morphine

Active Comparator group

Description:

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

Treatment:

Drug: Bupivacaine

Drug: Morphine

Intrathecal Morphine-Dex

Active Comparator group

Description:

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

Treatment:

Drug: Bupivacaine

Drug: Dexmedetomidine (Precedex)

Drug: Morphine