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Bupivacaine for Post-operative Pain in Mohs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04362566
Recruitment Status : Not yet recruiting
First Posted : April 27, 2020
Last Update Posted : April 27, 2020
Sponsor:
Collaborators:
University of Pennsylvania
Columbia University
Information provided by (Responsible Party):
Nicholas J Golda, 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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Narcotic Use Drug: Bupivacaine Other: Placebo Saline 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single-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
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Pain control [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 48 hours ]
    Documenting adverse effects, if any, from long-acting anesthetic that are different from the placebo group



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04362566


Contacts
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Contact: Nicholas Golda, MD 5732684969 goldan@health.missouri.edu

Sponsors and Collaborators
University of Missouri-Columbia
University of Pennsylvania
Columbia University
Investigators
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Principal Investigator: Nicholas J Golda, MD University of Missouri School of Medicine
Additional Information:
Publications:

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Responsible Party: Nicholas J Golda, Professor, Dermatology, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT04362566    
Other Study ID Numbers: 2022277
First Posted: April 27, 2020    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Patient data will be submitted from University of Pennsylvania and Columbia university to the University of Missouri primary research group for statistical analysis. The IPD will not be shared outside of this research team.

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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, University of Missouri-Columbia:
local anesthetic
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents