Acute Post-thoracotomy Pain
Conditions
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.
Interventions
perineural dexmedetomidine as an adjuvant to bupivacaine induced thoracic paravertebral block
perineural bupivacaine saline mixture in the thoracic paravertebral catheter
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| End tidal isoflurane | Duration of anesthesia, up to 3-4 hours | Average End-tidal isoflurane concentration required to maintain stable hemodynamics |
| 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 |
| 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 |
| Total intraoperative crystalloid requirements | Intraoperative period, up to 3-4 hours | The total volume of intraoperative fluids in ml required to maintain hemodynamic stability |
| 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 |
| 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. |
| 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 |
| Side effects | 48 hours postoperatively | Patients will be monitored for the possible reductions in arterial blood pressure and 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 |
Countries
Egypt
Outcome results
None listed