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

Cairo University (CU)

Status and phase: Completed; Phase 2

Conditions: Acute Post-thoracotomy Pain

Treatments: Drug: Bupivacaine saline; Drug: dexmedetomidine bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02397603

N-16-2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

bupivacaine saline group

Active Comparator group

Description:

This group of patients will receive 20 ml bupivacaine plus 0.5 ml normal saline perineurally in the paravertebral catheter

Treatment:

Drug: Bupivacaine saline

Dexmedetomidine- bupivacaine group

Active Comparator group

Description:

This group of patients will receive 20 ml bupivacaine plus 0.5 ml (50 microgram) dexmedetomidine administered perineurally in the paravertebral catheter.

Treatment:

Drug: dexmedetomidine bupivacaine