Clinical trial NCT02435537: Combined Intrathecal Morphine and Dexmedetomidine Analgesia
Official title: Safety and Efficacy of Dexmedetomidine Addition to Intrathecal Morphine for Postoperative Analgesia in Cancer Patients Undergoing Major Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Postoperative Pain
Keywords: analgesia
intrathecal
opioids
morphine
dexmedetomidine
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2015-05-06
Enrollment: 90
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: total dose of intravenous PCA morphine consumption in the first 48 h postoperative
timeFrame: 48 hours
Secondary outcomes:
measure: Noninvasive blood pressure
timeFrame: 48 hours
measure: Heart rate
timeFrame: 48 hours
measure: peripheral arterial oxygen saturation
timeFrame: 48 hours
measure: postoperative VAS scores
timeFrame: 48 hours
measure: time to first request for analgesia
timeFrame: 48hours
Other outcomes:
Locations:
Study officials:
affiliation: Assisstant professor in Anesthesia and intensive care department, South Egypt Cancer institute, Assiut university, Egypt
name: Saher AB Mohamed, MD
role: STUDY_DIRECTOR
affiliation: Assisstant professor in Anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt.
name: Hala s Abdel-Ghaffar, MD
role: STUDY_DIRECTOR
References:
citation: Abdel-Ghaffar HS, Mohamed SA, Fares KM. Combined Intrathecal Morphine and Dexmedetomidine for Postoperative Analgesia in Patients Undergoing Major Abdominal Cancer Surgery. Pain Med. 2016 Nov;17(11):2109-2118. doi: 10.1093/pm/pnw031. Epub 2016 Mar 21.