Clinical trial NCT04362566: Bupivacaine for Post-operative Pain in Mohs
Official title: Randomized Trial of Bupivacaine as Adjuvant for Post-operative Pain in Mohs Micrographic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Narcotic Use
Keywords: local anesthetic
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: Columbia University
First posted: 2020-04-27
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind RCT
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain control
timeFrame: 24 hours
Secondary outcomes:
measure: 48 hour pain control 1-10 scale
timeFrame: 48 hours
measure: 48 hour pain control drug type used if any
timeFrame: 48 hours
measure: 48 hour pain control drug amount used if any
timeFrame: 48 hours
measure: Adverse effects
timeFrame: 48 hours
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri-Columbia
state: Missouri
Study officials:
affiliation: University of Missouri School of Medicine
name: Nicholas J Golda, MD
role: PRINCIPAL_INVESTIGATOR
References:
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