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Postoperative Pain Management in Patients Undergoing Intramedullary Nail Fixation After Tibia and Femoral Fractures

Primary Purpose

Femur Fracture, Tibial Fractures

Status
Completed
Phase
Not Applicable
Locations
Puerto Rico
Study Type
Interventional
Intervention
Use of non-steroid anti-inflammatory drugs (NSAIDS) as an alternative for post-operative pain management after a femur and tibia fracture
Sponsored by
University of Puerto Rico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femur Fracture focused on measuring Opioid use, Post-operative pain, Analgesic use, Femur fracture, Tibia fracture, Intramedullary Nailing

Eligibility Criteria

18 Years - 110 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Patients with tibial and femoral shaft fractures
  2. Patients undergoing intramedullary nailing
  3. Willing to participate in the protocol

Exclusion Criteria:

  1. Chronic pain disorder (daily use of oral opioids)
  2. Allergy or hypersensitivity to non steroid anti-inflammatory drug
  3. Impaired renal, cardiac, or hepatic function
  4. History of gastrointestinal bleeding or substance abuse

Sites / Locations

  • University District Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1: Intravenous Ketorolac and oral acetaminophen

Group 2: Intravenous Morphine and oral oxycodone

Arm Description

Group 1 will be composed of patients receiving the following standard pain control protocol: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group. Patients who determine pain to be unbearable and wish to opt out of the non-opioid group will receive may do so.

Group 2 will be composed of patients receiving the following pain control protocol: morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.

Outcomes

Primary Outcome Measures

Pain scores using numerical rating scale (NRS, 0 to 10)
Pre-operative holding area
Pain scores using numerical rating scale (NRS, 0 to 10)
Post-operative 12 hours
Pain scores using numerical rating scale (VAS, 0 to 10)
Post-operative 24 hours
Pain scores using numerical rating scale (VAS, 0 to 10)
Post-operative 36 hours
Pain scores using numerical rating scale (VAS, 0 to 10)
Post-operative 48 hours

Secondary Outcome Measures

Adverse events related to postoperative pain drugs
Describe possible drug related complications such as: headache, nausea, vomit, dizziness, pruritus, urinary retention, constipation, gastrointestinal bleeding, cardiovascular complications, respiratory complications, delirium, among others
Cumulative Opioid Consumption
Recorded postoperative after discharge
Hospital Length of Stay
Time from intervention to discharge

Full Information

First Posted
February 16, 2021
Last Updated
June 28, 2023
Sponsor
University of Puerto Rico
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1. Study Identification

Unique Protocol Identification Number
NCT04761302
Brief Title
Postoperative Pain Management in Patients Undergoing Intramedullary Nail Fixation After Tibia and Femoral Fractures
Official Title
Postoperative Pain Management in Patients Undergoing Intramedullary Nail Fixation After Tibia and Femoral Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 18, 2021 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Puerto Rico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this trial is to determine whether oral acetaminophen and intravenous ketorolac are viable alternatives to opioid medication regimens for the pain management of patients with tibial and femoral shaft fractures treated with intramedullary nailing. This study will explore an alternative for opioid medications for patients undergoing intramedullary nailing of tibial and femoral shaft fractures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femur Fracture, Tibial Fractures
Keywords
Opioid use, Post-operative pain, Analgesic use, Femur fracture, Tibia fracture, Intramedullary Nailing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
167 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Intravenous Ketorolac and oral acetaminophen
Arm Type
Experimental
Arm Description
Group 1 will be composed of patients receiving the following standard pain control protocol: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group. Patients who determine pain to be unbearable and wish to opt out of the non-opioid group will receive may do so.
Arm Title
Group 2: Intravenous Morphine and oral oxycodone
Arm Type
Active Comparator
Arm Description
Group 2 will be composed of patients receiving the following pain control protocol: morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.
Intervention Type
Other
Intervention Name(s)
Use of non-steroid anti-inflammatory drugs (NSAIDS) as an alternative for post-operative pain management after a femur and tibia fracture
Intervention Description
This is a randomized controlled, single blind, parallel groups, opioid control trial of all patients (total of 150 patients) who suffered tibial and femoral shaft fractures and were treated with intramedullary nailing. Patients will be aleatory assigned to two study groups: Group-1 will receive non-opioid medications, and Group-2 will receive opioid medications. During the inpatient postoperative period, patients will undergo subjective evaluation of pain utilizing a previously validated questionnaire, the Visual Analogue Score (VAS). The first questionnaire will be completed twelve hours after surgery and during subsequent twelve-hour intervals until discharge. Secondary outcomes will include efficiency such as time to gastrointestinal motility, time to weight bearing of affected limb, resumption of ambulation, and length of hospital stay. The evaluation will take approximately 15 minutes to complete each time, we the entire participation time to be 60 minutes.
Primary Outcome Measure Information:
Title
Pain scores using numerical rating scale (NRS, 0 to 10)
Description
Pre-operative holding area
Time Frame
Three to five days
Title
Pain scores using numerical rating scale (NRS, 0 to 10)
Description
Post-operative 12 hours
Time Frame
Three to five days
Title
Pain scores using numerical rating scale (VAS, 0 to 10)
Description
Post-operative 24 hours
Time Frame
Three to five days
Title
Pain scores using numerical rating scale (VAS, 0 to 10)
Description
Post-operative 36 hours
Time Frame
Three to five days
Title
Pain scores using numerical rating scale (VAS, 0 to 10)
Description
Post-operative 48 hours
Time Frame
Three to five days
Secondary Outcome Measure Information:
Title
Adverse events related to postoperative pain drugs
Description
Describe possible drug related complications such as: headache, nausea, vomit, dizziness, pruritus, urinary retention, constipation, gastrointestinal bleeding, cardiovascular complications, respiratory complications, delirium, among others
Time Frame
Zero to 72 hours postoperative
Title
Cumulative Opioid Consumption
Description
Recorded postoperative after discharge
Time Frame
Zero to 72 hours postoperative
Title
Hospital Length of Stay
Description
Time from intervention to discharge
Time Frame
1 to 5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with tibial and femoral shaft fractures Patients undergoing intramedullary nailing Willing to participate in the protocol Exclusion Criteria: Chronic pain disorder (daily use of oral opioids) Allergy or hypersensitivity to non steroid anti-inflammatory drug Impaired renal, cardiac, or hepatic function History of gastrointestinal bleeding or substance abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis F. Lojo-Sojo, MD
Organizational Affiliation
Orthopaedic Surgery Section, University of Puerto Rico Medical Sciences Campus San Juan, Puerto Rico
Official's Role
Principal Investigator
Facility Information:
Facility Name
University District Hospital
City
San Juan
ZIP/Postal Code
00936
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Postoperative Pain Management in Patients Undergoing Intramedullary Nail Fixation After Tibia and Femoral Fractures

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