Kasr Alainy Hospital Cairo University
Giza, Egypt
Completed
NCT Number: NCT02397603
Peri-neural Dexmedetomidine as an Adjuvant to Bupivacaine Induced Paravertebral Block in Patients Undergonig Thoracotomy
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.
Completed
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Conditions
Age range
18 year–60 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
dexmedetomidine bupivacaine
Drugperineural dexmedetomidine as an adjuvant to bupivacaine induced thoracic paravertebral block
Bupivacaine saline
Drugperineural bupivacaine saline mixture in the thoracic paravertebral catheter
Primary outcomes
-
Duration of first loading preoperative dose of paravertebral injectate
Time frame: One day
Time interval between initiation of the paravertebral block and the time to first rescue analgesia
Secondary outcomes
-
Duration of surgery and anesthesia
Time frame: Intraoperative period, up to 3-4 hours
Times from start of anesthesia and surgery to the conclusion of surgical intervention
-
End tidal isoflurane
Time frame: Duration of anesthesia, up to 3-4 hours
Average End-tidal isoflurane concentration required to maintain stable hemodynamics
-
Total intraoperative fentanyl requirements
Time frame: Intraoperative period, up to 3-4 hours
The total dose of fentanyl required during the surgical procedure to maintain hemodynamic stability
-
Total intraoperative ephedrine and atropine requirements
Time frame: 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
-
Total intraoperative crystalloid requirements
Time frame: Intraoperative period, up to 3-4 hours
The total volume of intraoperative fluids in ml required to maintain hemodynamic stability
-
Recovery time
Time frame: Immediate postoperative period, up to 2 hour
the time interval between discontinuation of isoflurane and the patient first response to verbal commands
-
Pain intensities at rest and during coughing as assessed by 0-10 VAS score
Time frame: 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.
-
Total doses of bupivacaine, dexmedetomidine, and morphine
Time frame: 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
Time frame: 48 hours postoperatively
The number of to-up doses of bupivacaine required to maintain adequate postoperative analgesia over 48 hours postoperatively
-
Side effects
Time frame: 48 hours postoperatively
Patients will be monitored for the possible reductions in arterial blood pressure and heart rate
Sponsors and collaborators
Lead sponsor
Cairo University
Other
Registry information
Official study title
Peri-neural Dexmedetomidine as an Adjuvant to Bupivacaine-induced Paravertebral Block in Patients Undergoing Thoracotomy
Important dates
- Study start
- 2015
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Mar 25, 2015
- Registry last updated
- Feb 2, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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