Post Operative Pain ManagementNCT04008264
A Novel Usage of Transdermal Scopolamine in Reducing Narcotic Usage in Outpatient Hand Surgery
An observational study of Post Operative Pain Management, run by Alexander M Spiess, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Post Operative Pain Management
- What is being tested?
- Scopolamine Patch (Transderm V)
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2019to 1 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Adult
Study population: Patients between the ages of 18-55 undergoing outpatient hand and wrist surgery via sedation and a regional block
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Falk Clinic, 3601 Fifth Ave., Suite 6B
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the 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
- Being tested
- Scopolamine Patch (Transderm V)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scopolamine Patch (Transderm V)Drug
Also called Transderm Scop
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Scopolamine Patch (Transderm V) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 21 days
Secondary outcomes (1)
Number of non-opioid analgesics taken during study period
Determine patient compliance with usage of multi-modal analgesic medications and the feasibility of supplementing with an additional agent.The outcomes will be measured through review of post operative pain medication logs, and outcome surveys. Will record number of doses taken of tylenol and ibuprofen
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start25 Jun 2019
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexander M Spiess, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alexander M Spiess, MD, University of Pittsburgh
- Investigators
- Alexander Spiess, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008264
- Sponsor's protocol ID
- STUDY18100076
- Status last verified
- Sep 2022
- First submitted
- 20 Jun 2019
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Usage of Transdermal Scopolamine in Reducing Narcotic Usage in Outpatient Hand Surgery
- ClinicalTrials.gov ID
- NCT04008264
- Acronym / sponsor ID
- STUDY18100076
- Conditions
- Post Operative Pain Management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Alexander M Spiess, MDUniversity, hospital or other
- Study start
- 25 Jun 2019 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Drug: Scopolamine Patch (Transderm V)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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Age groups
- Adult
- Study population
- Patients between the ages of 18-55 undergoing outpatient hand and wrist surgery via sedation and a regional block
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scopolamine Patch (Transderm V)Also: Transderm ScopDuring 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. | Drug | Scopolomine group |
Primary outcome
Number of opioids taken during study period
Time frame: 21 days
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.
1 secondary outcome
Number of non-opioid analgesics taken during study period
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Spiess, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Operative Pain Management, run by Alexander M Spiess, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of opioids taken during study period (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2022.