Combined Intrathecal Morphine and Dexmedetomidine Analgesia

Postoperative Pain Clinical Trial

— ITMandDEX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02435537
• Other study ID #: IORG0006563/reference. no. 64
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 26, 2015
• Last updated: May 5, 2015
• Start date: May 2013
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Dexmedetomidine (Precedex)
intrathecal administration
• Bupivacaine
intrathecal 10 mg bupivacaine
• Morphine
intrathecal 0.5mg morphine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total dose of intravenous PCA morphine consumption in the first 48 h postoperative	Calculating the cumulative intravenous PCA morphine dose	48 hours	No
Secondary	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	Yes
Secondary	Heart rate	non invasive assessment of heart rate in the 6th, 12th, 18th, 24th, 36th, and 48th postoperative. intraoperative and postoperative	48 hours	Yes
Secondary	peripheral arterial oxygen saturation	assessment of pulse oximetry intraoperative and in the 6th, 12th, 18th, 24th, 36th, and 48th h postoperative	48 hours	Yes
Secondary	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	No
Secondary	time to first request for analgesia	measuring the time in hours of first request for intravenous PCA morphine	48hours	No