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

Phase 2

Completed

• Conditions: Acute Post-thoracotomy Pain
• Interventions: Drug: Bupivacaine saline; Drug: dexmedetomidine bupivacaine

• Registration Number: NCT02397603
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-03-15
• Study First Submitted QC: 2015-03-19
• Study First Posted: 2015-03-25
• Primary Completion: 2015-11
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-30
• Last Update Posted: 2016-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bupivacaine saline group	Bupivacaine saline	This group of patients will receive 20 ml bupivacaine plus 0.5 ml normal saline perineurally in the paravertebral catheter
Dexmedetomidine- bupivacaine group	dexmedetomidine bupivacaine	This group of patients will receive 20 ml bupivacaine plus 0.5 ml (50 microgram) dexmedetomidine administered perineurally in the paravertebral catheter.

Primary Outcome Measures

Name	Time	Method
Duration of first loading preoperative dose of paravertebral injectate	One day	Time interval between initiation of the paravertebral block and the time to first rescue analgesia

Secondary Outcome Measures

Name	Time	Method
Duration of surgery and anesthesia	Intraoperative period, up to 3-4 hours	Times from start of anesthesia and surgery to the conclusion of surgical intervention
Total doses of bupivacaine, dexmedetomidine, and morphine	48 hours postoperatively	The total doses of three medications will be recorded and compared in the intervention and control groups
Number of paravertebral to-up injections	48 hours postoperatively	The number of to-up doses of bupivacaine required to maintain adequate postoperative analgesia over 48 hours postoperatively
Total intraoperative crystalloid requirements	Intraoperative period, up to 3-4 hours	The total volume of intraoperative fluids in ml required to maintain hemodynamic stability
Total intraoperative fentanyl requirements	Intraoperative period, up to 3-4 hours	The total dose of fentanyl required during the surgical procedure to maintain hemodynamic stability
Pain intensities at rest and during coughing as assessed by 0-10 VAS score	Over 48 hours postoperatively	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.
Side effects	48 hours postoperatively	Patients will be monitored for the possible reductions in arterial blood pressure and heart rate
End tidal isoflurane	Duration of anesthesia, up to 3-4 hours	Average End-tidal isoflurane concentration required to maintain stable hemodynamics
Total intraoperative ephedrine and atropine requirements	Intraoperative period, up to 3-4 hours	The total amounts of ephidrine and atropine required for the treatment of possible reduction of arterial blood pressure or heart rate
Recovery time	Immediate postoperative period, up to 2 hour	the time interval between discontinuation of isoflurane and the patient first response to verbal commands

Trial Locations

Locations (1)

Kasr Alainy Hospital Cairo University; 🇪🇬 Giza, Egypt