Peri-neural Dexmedetomidine as an Adjuvant to Bupivacaine Induced Paravertebral Block in Patients Undergonig Thoracotomy

Acute Post-thoracotomy Pain Clinical Trial

Official title:

Peri-neural Dexmedetomidine as an Adjuvant to Bupivacaine-induced Paravertebral Block in Patients Undergoing Thoracotomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02397603
• Other study ID #: N-16-2015
• Status: Completed
• Phase: Phase 2
• First received: March 15, 2015
• Last updated: January 30, 2016
• Start date: February 2015
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Acute Post-thoracotomy Pain

Intervention

Drug:
• dexmedetomidine bupivacaine
perineural dexmedetomidine as an adjuvant to bupivacaine induced thoracic paravertebral block
• Bupivacaine saline
perineural bupivacaine saline mixture in the thoracic paravertebral catheter

Locations

Country	Name	City	State
Egypt	Kasr Alainy Hospital Cairo University	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of first loading preoperative dose of paravertebral injectate	Time interval between initiation of the paravertebral block and the time to first rescue analgesia	One day	No
Secondary	Duration of surgery and anesthesia	Times from start of anesthesia and surgery to the conclusion of surgical intervention	Intraoperative period, up to 3-4 hours	No
Secondary	End tidal isoflurane	Average End-tidal isoflurane concentration required to maintain stable hemodynamics	Duration of anesthesia, up to 3-4 hours	No
Secondary	Total intraoperative fentanyl requirements	The total dose of fentanyl required during the surgical procedure to maintain hemodynamic stability	Intraoperative period, up to 3-4 hours	No
Secondary	Total intraoperative ephedrine and atropine requirements	The total amounts of ephidrine and atropine required for the treatment of possible reduction of arterial blood pressure or heart rate	Intraoperative period, up to 3-4 hours	Yes
Secondary	Total intraoperative crystalloid requirements	The total volume of intraoperative fluids in ml required to maintain hemodynamic stability	Intraoperative period, up to 3-4 hours	No
Secondary	Recovery time	the time interval between discontinuation of isoflurane and the patient first response to verbal commands	Immediate postoperative period, up to 2 hour	No
Secondary	Pain intensities at rest and during coughing as assessed by 0-10 VAS score	Pain scores will be assessed using the 11-points visual analogue pain score (VAS) where 0 indicates no pain and 10 indicates the worst pain.	Over 48 hours postoperatively	No
Secondary	Total doses of bupivacaine, dexmedetomidine, and morphine	The total doses of three medications will be recorded and compared in the intervention and control groups	48 hours postoperatively	No
Secondary	Number of paravertebral to-up injections	The number of to-up doses of bupivacaine required to maintain adequate postoperative analgesia over 48 hours postoperatively	48 hours postoperatively	No
Secondary	Side effects	Patients will be monitored for the possible reductions in arterial blood pressure and heart rate	48 hours postoperatively	Yes