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

Condition(s) targeted: Acute Post-thoracotomy Pain

Intervention: dexmedetomidine bupivacaine (Drug); Bupivacaine saline (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Cairo University

Official(s) and/or principal investigator(s):
Mohamed Abdulatif, MD., Principal Investigator, Affiliation: Professor of anesthesia, surgical intensive care and pain management cairo university

Overall contact:
Mostafa A Eltantawy, MBBCH, Phone: 002-01005279908, Email: eltantawymostafa@yahoo.com

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.

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

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

Primary outcome: Duration of first loading preoperative dose of paravertebral injectate

Secondary outcome:

Duration of surgery and anesthesia

End tidal isoflurane

Total intraoperative fentanyl requirements

Total intraoperative ephedrine and atropine requirements

Total intraoperative crystalloid requirements

Recovery time

Pain intensities at rest and during coughing as assessed by 0-10 VAS score

Total doses of bupivacaine, dexmedetomidine, and morphine

Number of paravertebral to-up injections

Side effects

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.

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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.

Mostafa A Eltantawy, MBBCH, Phone: 002-01005279908, Email: eltantawymostafa@yahoo.com

Kasr Alainy Hospital Cairo University, Giza, Egypt; Recruiting

Starting date: February 2015
Last updated: March 19, 2015