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Bupivacaine for Post-operative Pain in Mohs

Sponsor
University of Missouri-Columbia (Other)
Overall Status
Completed
CT.gov ID
NCT04362566
Collaborator
University of Pennsylvania (Other), Columbia University (Other)
174
Enrollment
1
Location
2
Arms
14
Actual Duration (Months)
12.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
174 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Single-blind RCTSingle-blind RCT
Masking:
Single (Participant)
Masking Description:
Patients will receive long acting local anesthetic or saline placebo postoperatively, they will be blinded to the arm they are in
Primary Purpose:
Treatment
Official Title:
Randomized Trial of Bupivacaine as Adjuvant for Post-operative Pain in Mohs Micrographic Surgery
Actual Study Start Date :
Jul 30, 2020
Actual Primary Completion Date :
Sep 30, 2021
Actual Study Completion Date :
Sep 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Bupivicaine

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

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
Placebo Comparator: Placebo saline

Saline in the same volume as described above for bupivicaine

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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

  3. 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

  4. Adverse effects [48 hours]

    Documenting adverse effects, if any, from long-acting anesthetic that are different from the placebo group

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
    1. Adult (18 years or older) patients being treated with Mohs micrographic surgery will be included in this study.
  1. 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:
    1. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Missouri-Columbia Columbia Missouri United States 65212

Sponsors and Collaborators

  • University of Missouri-Columbia
  • University of Pennsylvania
  • Columbia University

Investigators

  • Principal Investigator: Nicholas J Golda, MD, University of Missouri School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Nicholas J Golda, Professor, Dermatology, University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT04362566
Other Study ID Numbers:
  • 2022277
First Posted:
Apr 27, 2020
Last Update Posted:
Oct 21, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Nicholas J Golda, Professor, Dermatology, University of Missouri-Columbia
local anesthetic
Additional relevant MeSH terms:
Pain, Postoperative
Bupivacaine

Study Results

No Results Posted as of Oct 21, 2021