A Novel Usage of Transdermal Scopolamine in Reducing Narcotic Usage in Outpatient Hand Surgery

NCT ID: NCT04008264

Last Updated: 2022-09-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 74 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-25
• Study Completion Date: 2022-07-01

Brief Summary

The investigators will examine and analyze opioid narcotic usage patterns by requesting patients keep a two week log of their opioid usage following outpatient hand surgery with a standard analgesic regimen consisting of an opioid, NSAID, and acetaminophen. Following a pre-intervention period, the investigators will add scopolamine to the regimen and have patients monitor their opioid consumption. The investigators will then compare opioid consumption patterns following completion of the study.

Detailed Description

Aim 1: Determine whether the addition of transdermal scopolamine to a standard analgesic regimen reduces opioid utilization following outpatient hand surgery as reported by patients Objectives: The investigators will compare opioid usage between patients who complete logs during the pre-intervention stage of the study and the intervention stage of the study to determine the effect of including scopolamine as a medication in standard post-operative analgesic regimens following outpatient hand surgery. As this is the primary objective of our study, an a priori power analysis was conducted. Based on a two-sided two-sample independent t-test with a specified significant level of 0.05, a power of 0.8, and a moderate effect size of 0.5; 64 patients will need to complete each portion of the study to provide an overall sample size of 128 patients.

Outcome Variables and Analysis: The absolute number of logged opioid use during the two-week study period will be compared between the pre-intervention and intervention groups using a two-sided independent samples t-test.

Aim 2: Determine patient compliance with usage of multi-modal analgesic medications and the feasibility of supplementing with an additional agent Objectives: During the pre-intervention stage of the trial, the investigators will encourage patients to utilize non-opioid analgesics over opioids and have patients keep a log of their NSAID and acetaminophen usage. This aim will partially establish whether patients are being adequately counseled regarding multi-modal pain control as patients with high opioid consumption should also have high rates of use of their non-opioid analgesics. It will also establish whether it is feasible to expect patients to comply with the introduction of novel medications into analgesic regimens. It will establish baseline rates of non-narcotic pain medication use overall and stratified by procedure. It may also further support the existing evidence that non-opioid pain medications reduce opioid requirements while providing more significant pain relief than opioids alone.

Outcome Variables and Analysis: Data analyzed will include percentage of individual non-opioid pain medications used (prescriptions will be provided so patient could take medication around the clock), patient pain scores, and percentage of opioids used. Percentages of non-opioid pain medications and opioid pain medications will be compared on a patient-by-patient basis by utilizing a paired t-test. The association between patient perceived pain levels and percentage of each medication used will be determined with multiple linear regression.

Aim 3: Aim 3: Assess patient and operative factors that contribute to prolonged or greater than expected opioid usage.

Objectives: The factors contributing to prolonged patient use of opioids and need for repeated refills are poorly understood. An analysis of factors contributing to prolonged opioid use and a determination of baseline opioid use rates would allow hand surgeons to have a better understanding of factors that may place a patient at risk or to identify when patients are exceeding the typical requirements for opioids. Identification of these patients may allow for increased counseling, referral to a pain specialist, or increased surveillance. Details of the operative procedure and typical narcotic requirements will guide providers in prescribing more limited opioid prescriptions appropriate to an individual procedure with few to no refills authorized.

Outcome Variables and Analysis: Patients will be separated into groups based on whether they used over 80% of their opioid prescription or if they requested a refill of their opioid prescription within the two week study period. A univariate analysis of patient demographic factors and operative details will identify factors that are potentially associated with higher rates of opioid consumption following surgery. Chi square tests will be performed for categorical variables and student's t-tests will be used for continuous variables. Binary logistic regression will then be performed using variables identified in the univariate screen in order to identify independent factors contributing to a higher number of opioids used after surgery.

Conditions

Post Operative Pain Management

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Standard post operative pain regimen

There will be a 3 month pre-intervention phase where participants will be placed on a standard post-operative analgesic regimen consisting of an opioid, a NSAID, and acetaminophen. Patients will record their narcotic and non-opioid analgesic usage patterns in the two weeks following outpatient hand surgery.

No interventions assigned to this group

Scopolomine group

During the observational phase, patients will be on scopolamine for a total 6 day course (one patch applied at time of surgery, prescription for one patch), and patients will record their narcotic and non-opioid analgesic usage patterns in the two weeks following outpatient hand surgery. The patients who incorporate scopolamine into their post operative analgesia regimen will be eligible for inclusion in the study.

Scopolamine Patch (Transderm V)

Intervention Type: DRUG

During the observational phase, patients will be given a prescription for an 18 day supply of scopolamine, and patients will record the same data as prior to the intervention.

Interventions

Scopolamine Patch (Transderm V)

During the observational phase, patients will be given a prescription for an 18 day supply of scopolamine, and patients will record the same data as prior to the intervention.

Intervention Type: DRUG

Other Intervention Names

Transderm Scop

Eligibility Criteria

Inclusion Criteria

• Patients between the ages of 18-55 undergoing outpatient hand and wrist surgery via sedation and a regional block
• Procedures eligible for inclusion will be limited to those involving the wrist and the hand.

Exclusion Criteria

• Patients undergoing procedures under local, regional anesthesia alone, sedation alone, and general endotracheal anesthesia
• Patients with a history of acute angle closure or open angle glaucoma;
• History of drug hypersensitivity to scopolamine, other belladonna alkaloids, or any other ingredient or component in the formulation or delivery system;
• History of previous gastrointestinal or urinary bladder obstruction;
• History of seizures or psychosis; patients with hepatic or renal impairment;
• Patients under the age of 18 or over the age of 55;
• Patients who are currently pregnant or nursing.
• Patients currently using prescription opioids for other chronic medical conditions or who are actively using heroin.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexander M Spiess, MD

OTHER

Sponsor Role: lead

Responsible Party

Alexander M Spiess, MD

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Alexander Spiess, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Falk Clinic, 3601 Fifth Ave., Suite 6B

Pittsburgh, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STUDY18100076

Identifier Type: -

Identifier Source: org_study_id