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

NCT04008264 | Completed DMC

• 1 other identifier: STUDY18100076
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain Management

Outcome Measures

Primary Outcomes (1)

• Number of opioids taken during study period

  Determine whether the addition of transdermal scopolamine to a standard analgesic regimen reduces opioid utilization following outpatient hand surgery as reported by patients. The outcomes will be measured through review of post operative pain medication logs, and outcome surveys.

  21 days

Secondary Outcomes (1)

• Number of non-opioid analgesics taken during study period

  21 days

Other Outcomes (1)

• Pain Medication Usage beyond 20 day study period

  9 months

Study Arms (2)

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.

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.

Drug: Scopolamine Patch (Transderm V)

Interventions

Scopolamine Patch (Transderm V) 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.

Also known as: Transderm Scop

Scopolomine group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients between the ages of 18-55 undergoing outpatient hand and wrist surgery via sedation and a regional block

You may qualify if:

• Patients between the ages of 18-55 undergoing outpatient hand and wrist surgery via sedation and a regional block

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexander M Spiess, MD: lead

Study Sites (1)

Falk Clinic, 3601 Fifth Ave., Suite 6B

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Interventions

Butylscopolammonium Bromide; Scopolamine

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Belladonna Alkaloids; Solanaceous Alkaloids

Study Officials

• Alexander Spiess, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: July 5, 2019
• Study Start: June 25, 2019
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: September 8, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)