Bupivacaine for Post-operative Pain in Mohs

Phase 4

Completed

• Conditions: Narcotic Use; Pain, Postoperative
• Interventions: Other: Placebo Saline; Drug: Bupivacaine

• Registration Number: NCT04362566
• Lead Sponsor: University of Missouri-Columbia

Brief 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.

Detailed Description

Mohs micrographic surgery (MMS) is the first-line treatment for high-risk nonmelanoma skin cancer (NMSC) and is increasingly used for melanoma and other cutaneous neoplasms. The surgical technique involves multiple stages of surgery followed by reconstruction and is typically performed under local anesthesia in the office setting in one day.

MMS is generally well tolerated, but post-operative pain is common. Pain peaks on the day of surgery and slowly declines in subsequent days. Risk factors for increased pain may include flap or graft repair type, location on scalp, lip, nose, or ear, younger age, and increased number of lesions treated. Post-operative pain medication is not standardized in dermatological surgery, but often includes non-narcotic analgesics including acetaminophen and ibuprofen, and less commonly narcotic analgesics such as tramadol and oxycodone. Given the current national trend to reduce opioid use, a multimodal approach to pain management has been adopted by many surgical specialties to optimize analgesia perioperatively.

The most commonly used anesthetic in MMS is local subcutaneous infiltration of lidocaine 0.5 - 2% with 1:100,000 - 1:200,000 epinephrine. Lidocaine is quick-acting, can be buffered to reduce injection pain, and is well tolerated, but the duration of action is only two hours, making it less effective for post-operative pain. Bupivacaine with epinephrine has a longer duration of action compared to lidocaine (up to four hours), but it is rarely used alone due to slower onset of action and more painful injection compared with lidocaine. Bupivacaine is used in many other surgical specialties, including general, plastic, and orthopedic surgery, as a peri-operative adjuvant and has been shown to reduce post-operative opioid use. It is generally well tolerated, carrying a class-effect risk of cardiac toxicity in high doses as does lidocaine, but has been shown to be safe in dermatologic surgery when used for wound infiltration. A newer formulation of liposomal bupivacaine has been shown to be even longer lasting and safer, with pain control up to 72 hours and no reported cardiac toxicity. In addition, a recent study has showed subcutaneous infiltration of bupivacaine with epinephrine to be an effective intra-operative pain adjuvant during MMS compared to lidocaine alone.

Pain control post-operatively in MMS may be optimized by including bupivacaine injections at the end of the surgical procedure given its long-lasting anesthetic effects. There are currently no studies addressing the use of bupivacaine as an adjuvant to control post-operative pain during MMS. The investogators propose a prospective randomized controlled trial to evaluate the effectiveness of bupivacaine injection at the conclusion of surgery for reducing post-operative pain and analgesic use.

Study Timeline

• Study First Submitted: 2020-04-16
• Study First Submitted QC: 2020-04-22
• Study First Posted: 2020-04-27
• Study Start: 2020-07-30
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-19
• Last Update Posted: 2021-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 174

Inclusion Criteria

• a. Adult (18 years or older) patients being treated with Mohs micrographic surgery will be included in this study.

  b. Surgical procedure must include one of the following:

  1. Scalp rotation/transposition/advancement flap
  2. Ear rotation/transposition/advancement/interpolation flap or wedge repair
  3. Nose rotation/transposition/advancement/interpolation flap, cartilage alar-batten graft (ear donor site)
  4. Cheek Mustarde flap
  5. Lip rotation/transposition/advancement flap, wedge repair, Abbe flap

Exclusion Criteria

• c. Patients must not

  1. be pregnant or breastfeeding
  2. be taking scheduled narcotic medications
  3. use narcotics as a drug of abuse
  4. have an allergy to bupivacaine or other amide anesthetics
  5. have a contraindication to tramadol
  6. have been given narcotic pain medications during the Mohs procedure or subsequent reconstruction
  7. have multiple surgical sites treated on the same day

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo saline	Placebo Saline	Saline in the same volume as described above for bupivicaine
Bupivicaine	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

Primary Outcome Measures

Name	Time	Method
Pain control	24 hours	Determination if bupivacaine injection postoperatively in clinical scenarios where higher postoperative pain is expected (see protocol) changes the need for narcotic medication (using a binary Yes or No measure) during first 24 hours post-surgery

Secondary Outcome Measures

Name	Time	Method
48 hour pain control 1-10 scale	48 hours	Postoperative pain levels (1-10 scale) during 48 hours following surgery in the intervention and control groups
48 hour pain control drug type used if any	48 hours	48 hour pain control drug type (narcotic versus nonnarcotic versus none) in the intervention and control groups
48 hour pain control drug amount used if any	48 hours	Determination of the amount (number of doses) of various pain control drugs (narcotic versus nonnarcotic versus none) needed during 48 hours following operation and calculating if there is a difference between the intervention and control groups
Adverse effects	48 hours	Documenting adverse effects, if any, from long-acting anesthetic that are different from the placebo group

Trial Locations

Locations (1)

University of Missouri-Columbia; 🇺🇸 Columbia, Missouri, United States