Pain, Postoperative Clinical Trial
Official title:
Randomized Trial of Bupivacaine as Adjuvant for Post-operative Pain in Mohs Micrographic Surgery
Verified date | October 2021 |
Source | University of Missouri-Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 174 |
Est. completion date | September 30, 2021 |
Est. primary completion date | September 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Missouri-Columbia | Columbia | Missouri |
Lead Sponsor | Collaborator |
---|---|
University of Missouri-Columbia | Columbia University, University of Pennsylvania |
United States,
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain control | 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 | 24 hours | |
Secondary | 48 hour pain control 1-10 scale | Postoperative pain levels (1-10 scale) during 48 hours following surgery in the intervention and control groups | 48 hours | |
Secondary | 48 hour pain control drug type used if any | 48 hour pain control drug type (narcotic versus nonnarcotic versus none) in the intervention and control groups | 48 hours | |
Secondary | 48 hour pain control drug amount used if any | 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 | 48 hours | |
Secondary | Adverse effects | Documenting adverse effects, if any, from long-acting anesthetic that are different from the placebo group | 48 hours |
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