Botulinum Toxin for Post Abdominoplasty Pain Control

• Status: Not yet recruiting
• Trial end date: 0000-00-00
• Target enrollment: 50
• Participant gender: Female

Summary

We are investigating ways to reduce pain after abdominoplasty. We hypothesize that injection of Dysport (botulinum toxin A) into the rectus abdominis, abdominal wall musculature, during abdominoplasty will provide a more effective, longer lasting method for pain control than standard of care alone (use of Exparel (liposomal bupivacaine) intraoperatively followed by PRN narcotics. We will randomize patients to receive either Disport + standard of care or saline (placebo) + standard of care and compare post operative pain for the following 2-3 months.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Virginia Commonwealth University
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA
• Last Updated: 2016-07-20

Criteria

Inclusion Criteria:

• non-pregnant, non-nursing patients over age 18 years with the ability to provide informed consent, undergoing abdominoplasty at the treating surgeon's outpatient surgical center

Exclusion Criteria:

• a history of pre-existing neuromuscular disorders such as myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis, hypersensitivity or allergy to either Dysport, Exparel, or cow's milk protein, use of aminoglycosides at the time of surgery (as these antibiotics can potentiate the effect of Botulinum toxin or BT), reported use of BT in the four months preceding surgery, daily pre-operative opioid use, skin infection at the planned surgical site, BMI > 30