Clinical trial NCT02397603: Peri-neural Dexmedetomidine as an Adjuvant to Bupivacaine Induced Paravertebral Block in Patients Undergonig Thoracotomy
Official title: Peri-neural Dexmedetomidine as an Adjuvant to Bupivacaine-induced Paravertebral Block in Patients Undergoing Thoracotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Post-thoracotomy Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2015-03-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effect of adding dexmedetomidine as an adjuvant to bupivacaine in patients undergoing thoracotomy when administered peri-neurally in thoracic paravertebral space.

Detailed description: Thoracotomy is associated with severe postoperative pain that could be reduced with an aggressive analgesic therapy in the early postoperative period. The use of thoracic paravertebral block is an effective analgesic approach for post-thoracotomy pain. Several local anesthetic adjuvants have been reported to extend the duration of paravertebral block.

Alpha-2 agonists including dexmedetomidine appear to be the most effective in this context. The study will include an intervention group which will receive a combination of 20 ml bupivacaine 0.5% and dexmedetomidine 0.5 ml (50 microgram). The control group will receive 20 ml bupivacaine 0.5% plus 0.5 ml normal saline perineurally. Thoracic paravertebral catheter will be inserted preoperatively. Visual analogue pain score will be assessed at different intervals.

Eligibility criteria: Inclusion Criteria:

* American society of anesthesiologists physical status class \|\|or \|\|\|.
* Patients scheduled for elective thoracotomy.

Exclusion Criteria:

* Pneumonectomy, decortication, pleural biopsy.
* Additional chest wall resection.
* Emergency surgery.
* Central and peripheral neuropathies.

Primary outcomes:
measure: Duration of first loading preoperative dose of paravertebral injectate
timeFrame: One day
Secondary outcomes:
measure: Duration of surgery and anesthesia
timeFrame: Intraoperative period, up to 3-4 hours
measure: End tidal isoflurane
timeFrame: Duration of anesthesia, up to 3-4 hours
measure: Total intraoperative fentanyl requirements
timeFrame: Intraoperative period, up to 3-4 hours
measure: Total intraoperative ephedrine and atropine requirements
timeFrame: Intraoperative period, up to 3-4 hours
measure: Total intraoperative crystalloid requirements
timeFrame: Intraoperative period, up to 3-4 hours
measure: Recovery time
timeFrame: Immediate postoperative period, up to 2 hour
measure: Pain intensities at rest and during coughing as assessed by 0-10 VAS score
timeFrame: Over 48 hours postoperatively
measure: Total doses of bupivacaine, dexmedetomidine, and morphine
timeFrame: 48 hours postoperatively
measure: Number of paravertebral to-up injections
timeFrame: 48 hours postoperatively
measure: Side effects
timeFrame: 48 hours postoperatively
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Kasr Alainy Hospital Cairo University
Study officials:
affiliation: Professor of anesthesia, surgical intensive care and pain management cairo university
name: Mohamed Abdulatif, MD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marhofer D, Kettner SC, Marhofer P, Pils S, Weber M, Zeitlinger M. Dexmedetomidine as an adjuvant to ropivacaine prolongs peripheral nerve block: a volunteer study. Br J Anaesth. 2013 Mar;110(3):438-42. doi: 10.1093/bja/aes400. Epub 2012 Nov 15.