Combined Intrathecal Morphine and Dexmedetomidine Analgesia
- Conditions
- Postoperative Pain
- Interventions
- Registration Number
- NCT02435537
- Lead Sponsor
- Assiut University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- major abdominal cancer surgery (e.g. hemi-colectomy or cystectomy)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intrathecal Morphine Morphine intrathecal injection of 10mg bupivacaine 0.5% in 2ml volume intrathecal injection of 0.5 mg morphine in 1ml volume Intrathecal Morphine-Dex Dexmedetomidine (Precedex) intrathecal 10mg bupivacaine 0.5% in 2 ml volume intrathecal 0.5 mg morphine intrathecal 5 µg of dexmedetomidine in 1ml volume . Intrathecal Morphine-Dex Bupivacaine intrathecal 10mg bupivacaine 0.5% in 2 ml volume intrathecal 0.5 mg morphine intrathecal 5 µg of dexmedetomidine in 1ml volume . Intrathecal Bupivacaine Bupivacaine intrathecal injection of 10 mg hyperbaric bupivacaine 0.5% in 2 ml volume and 1ml of saline 0.9% Intrathecal Morphine Bupivacaine intrathecal injection of 10mg bupivacaine 0.5% in 2ml volume intrathecal injection of 0.5 mg morphine in 1ml volume Intrathecal Morphine-Dex Morphine intrathecal 10mg bupivacaine 0.5% in 2 ml volume intrathecal 0.5 mg morphine intrathecal 5 µg of dexmedetomidine in 1ml volume .
- Primary Outcome Measures
Name Time Method total dose of intravenous PCA morphine consumption in the first 48 h postoperative 48 hours Calculating the cumulative intravenous PCA morphine dose
- Secondary Outcome Measures
Name Time Method time to first request for analgesia 48hours measuring the time in hours of first request for intravenous PCA morphine
Noninvasive blood pressure 48 hours non invasive systolic and diastolic blood pressure intra-operative and postoperative in the 6th, 12th, 18th, 24th, 36th, and 48th h postoperative.
Heart rate 48 hours non invasive assessment of heart rate in the 6th, 12th, 18th, 24th, 36th, and 48th postoperative. intraoperative and postoperative
postoperative VAS scores 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.
peripheral arterial oxygen saturation 48 hours assessment of pulse oximetry intraoperative and in the 6th, 12th, 18th, 24th, 36th, and 48th h postoperative