Bupivacaine for Post-operative Pain in Mohs

Summary

Mohs micrographic surgery (MMS) is regarded as the gold standard for the treatment of high-risk nonmelanoma skin cancer (NMSC). Pain after MMS peaks on the day of surgery and slowly decreases thereafter. The most common post-operative analgesics include acetaminophen, ibuprofen and narcotics. Lidocaine is the most commonly used anesthetic in MMS, but bupivacaine has been shown in other surgical specialties to be an effective adjuvant to reduce post-operative pain and opioid use when injected locally in the immediate postoperative period. Bupivacaine has also been shown to reduce intra-operative pain during MMS. The investigators plan a single-blinded prospective, randomized, controlled trial to determine if post-operative wound infiltration of bupivacaine versus normal saline improves post-operative pain and decreases need for post-operative pain medications including both narcotic and nonnarcotic analgesics.

Conditions

• Pain, Postoperative
• Narcotic Use

Interventions

DRUG

Bupivacaine

Scalp flap: 2.5cc bupivacaine for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc, Ear flap or wedge repair: 2.5cc bupivacaine for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc Nose flap, 2.5cc bupivacaine for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc. Split volume between nose and donor site for melolabial interpolated flap Paramedian forehead flap: 5cc split between forehead donor site and nasal recipient site: 4cc forehead, 1cc nose Cartilage alar-batten graft (ear donor site) 1cc at auricular donor site in addition to bupivacaine used for nasal reconstruction, if any, that qualifies above Cheek Mustarde flap: 2.5cc bupivacaine for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc Lip flap, wedge repair, Abbe flap: 2.5cc bupivacaine for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc

OTHER

Placebo Saline

Scalp flap: 2.5cc salinefor 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc, Ear flap or wedge repair: 2.5cc saline for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc Nose flap, 2.5cc saline for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc. Split volume between nose and donor site for melolabial interpolated flap Paramedian forehead flap: 5cc split between forehead donor site and nasal recipient site: 4cc forehead, 1cc nose Cartilage alar-batten graft (ear donor site) 1cc at auricular donor site in addition to saline used for nasal reconstruction, if any, that qualifies above Cheek Mustarde flap: 2.5cc saline for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc Lip flap, wedge repair, Abbe flap: 2.5cc saline for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc

Sponsors & Collaborators

• University of Pennsylvania

  collaborator OTHER

• Columbia University

  collaborator OTHER

• University of Missouri-Columbia

  lead OTHER

Principal Investigators

• Nicholas J Golda, MD · University of Missouri School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-07-30

Primary Completion

2021-09-30

Completion

2021-09-30

FDA Drug

Yes

Countries

• United States

Study Locations