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Pain Outcomes of Intra-operative IV Tylenol and/or IV Toradol for Carpal Tunnel and Distal Radius Fracture Surgeries

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ClinicalTrials.gov Identifier: NCT02313675
Recruitment Status : Completed
First Posted : December 10, 2014
Results First Posted : May 4, 2018
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
John Fowler, University of Pittsburgh

Brief Summary:
The purpose of this study is to determine the efficacy of intra-operative administration of IV tylenol and/or IV toradol in minimizing post-operative pain for carpal tunnel patients and distal radius fracture patients.

Condition or disease Intervention/treatment Phase
Postoperative Pain Carpal Tunnel Release Distal Radius Fracture Drug: Acetaminophen Drug: Ketorolac Tromethamine Drug: Saline Phase 4

Detailed Description:

The study population will include patients presenting for surgery with carpal tunnel syndrome as well as surgical treatment of distal radius fracture. Patients will be treated intra-operatively with either IV tylenol, IV toradol, both, or neither. All patients will receive the standard post-operative prescriptions for pain management. Daily pain surveys scoring pain from 0-10 will be distributed to the subjects to be filled out over the course of 10 days prior to first post-operative visit, usually 10-14 days later. Number of pain pills used before the first post-operative visit will also be measured.

We hypothesize that the effects of intra-operative administration of IV tylenol and/or IV toradol will have a significant effect on decreasing post-operative pain in the first 10 days following distal radius fracture surgeries, with a significant difference in pain described as at least a 2 points on a 0-10 pain scale.

We also hypothesize that intra-operative administration of IV tylenol and/or IV toradol will not have such significant effect on decreasing post-operative pain for carpal tunnel release surgery.

A secondary aim is to evaluate the post-operative opioid consumption of patients within these treatment groups. We hypothesize that opioid consumption will be decreased in the groups receiving IV tylenol and/or toradol for distal radius fracture surgery compared to the placebo group. We do not expect such a difference for the carpal tunnel release surgery group.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparing Pain Outcomes of Intra-operative IV Tylenol and/or IV Toradol Administration for Carpal Tunnel Release and Distal Radius Fracture Surgeries
Study Start Date : May 2015
Actual Primary Completion Date : May 1, 2017
Actual Study Completion Date : May 1, 2017


Arm Intervention/treatment
Experimental: IV tylenol
One time intra-operative IV acetaminophen administration
Drug: Acetaminophen
Other Name: tylenol

Experimental: IV toradol
One time intra-operative IV ketorolac thromethamine administration
Drug: Ketorolac Tromethamine
Other Name: toradol

Experimental: IV tylenol/toradol combination
One time intra-operative IV combination of acetaminophen/ketorolac administration
Drug: Acetaminophen
Other Name: tylenol

Drug: Ketorolac Tromethamine
Other Name: toradol

Placebo Comparator: saline
One time intra-operative 50ml IV normal saline administration
Drug: Saline



Primary Outcome Measures :
  1. Postoperative Pain (Pain Scores From 0-10 Scale) [ Time Frame: 7 days ]
    This is an ordinal pain scale. The patient picks a number from 0-10 scale every 4 hours for 7 days post-operatively. 0 is no pain, 10 is the worst pain imaginable. Lower scores would be preferable to higher scores.


Secondary Outcome Measures :
  1. Opioid Consumption (Number of Pills Taken) [ Time Frame: 7 days ]

    Daily opioid consumption assessed as number of pills taken that day, each day for 7 days post-operatively

    Outcome measure reported below is mean number of opioid pills consumed per day.




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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:

  • carpal tunnel release surgery candidates,
  • distal radius fracture surgery candidates

Exclusion Criteria:

  • under 18 years of age,
  • pregnant women,
  • prisoners

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): NCT02313675


Locations
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United States, Pennsylvania
Kaufmann Building
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
John Fowler
  Study Documents (Full-Text)

Documents provided by John Fowler, University of Pittsburgh:
Study Protocol  [PDF] January 25, 2017
Statistical Analysis Plan  [PDF] January 25, 2017


Publications:
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Responsible Party: John Fowler, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02313675     History of Changes
Other Study ID Numbers: PRO14110464
First Posted: December 10, 2014    Key Record Dates
Results First Posted: May 4, 2018
Last Update Posted: May 4, 2018
Last Verified: April 2018
Keywords provided by John Fowler, University of Pittsburgh:
carpal tunnel syndrome
opioid analgesics
postoperative pain
IV tylenol
IV toradol
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Pain, Postoperative
Fractures, Bone
Radius Fractures
Wounds and Injuries
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Forearm Injuries
Arm Injuries
Acetaminophen
Ketorolac
Ketorolac Tromethamine
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal