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

Tibial Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04761302
• Other study ID #: A9290220
• Status: Completed
• Phase: N/A
• Start date: April 18, 2021
• Est. completion date: October 1, 2022

Study information

• Verified date: June 2023
• Source: University of Puerto Rico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Femoral Fractures
• Femur Fracture
• Fractures, Bone
• Pain, Postoperative
• Tibial Fractures

Intervention

Other:
• Use of non-steroid anti-inflammatory drugs (NSAIDS) as an alternative for post-operative pain management after a femur and tibia fracture
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.

Locations

Country	Name	City	State
Puerto Rico	University District Hospital	San Juan

Sponsors (1)

Lead Sponsor	Collaborator
University of Puerto Rico

Country where clinical trial is conducted

Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scores using numerical rating scale (NRS, 0 to 10)	Pre-operative holding area	Three to five days
Primary	Pain scores using numerical rating scale (NRS, 0 to 10)	Post-operative 12 hours	Three to five days
Primary	Pain scores using numerical rating scale (VAS, 0 to 10)	Post-operative 24 hours	Three to five days
Primary	Pain scores using numerical rating scale (VAS, 0 to 10)	Post-operative 36 hours	Three to five days
Primary	Pain scores using numerical rating scale (VAS, 0 to 10)	Post-operative 48 hours	Three to five days
Secondary	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	Zero to 72 hours postoperative
Secondary	Cumulative Opioid Consumption	Recorded postoperative after discharge	Zero to 72 hours postoperative
Secondary	Hospital Length of Stay	Time from intervention to discharge	1 to 5 days