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

NCT ID: NCT02397603

Last Updated: 2016-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2015-12-31

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.

Conditions

Acute Post-thoracotomy Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

bupivacaine saline group

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

Group Type: ACTIVE_COMPARATOR

Bupivacaine saline

Intervention Type: DRUG

perineural bupivacaine saline mixture in the thoracic paravertebral catheter

Dexmedetomidine- bupivacaine group

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

Group Type: ACTIVE_COMPARATOR

dexmedetomidine bupivacaine

Intervention Type: DRUG

perineural dexmedetomidine as an adjuvant to bupivacaine induced thoracic paravertebral block

Interventions

dexmedetomidine bupivacaine

perineural dexmedetomidine as an adjuvant to bupivacaine induced thoracic paravertebral block

Intervention Type: DRUG

Bupivacaine saline

perineural bupivacaine saline mixture in the thoracic paravertebral catheter

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Professor Mohamed Abdulatif Mohamed

Professor of Anesthesiology & Surgical Intensive Care, Faculity of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed Abdulatif, MD.

Role: PRINCIPAL_INVESTIGATOR

Professor of anesthesia, surgical intensive care and pain management cairo university

Locations

Kasr Alainy Hospital Cairo University

Giza, , Egypt

Countries

Egypt

References

Marhofer D, Kettner SC, Marhofer P, Pils S, Weber M, Zeitlinger M. Dexmedetomidine as an adjuvant to ropivacaine prolongs peripheral nerve block: a volunteer study. Br J Anaesth. 2013 Mar;110(3):438-42. doi: 10.1093/bja/aes400. Epub 2012 Nov 15.

Reference Type: RESULT

PMID: 23161360 (View on PubMed)

Other Identifiers

N-16-2015

Identifier Type: -

Identifier Source: org_study_id