Efficacy of Multimodal Analgesia Following Hip Arthroscopy

NCT03351439 | Completed

• 1 other identifier: 110350
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the full study is to determine whether multimodal analgesia for hip arthroscopy will reduce post-operative pain scores, narcotic consumption and hospital length-of-stay. To do this, the investigators will compare the standard of care (SOC), with routine pain management with a post-operative opioid prescription, to three different groups with multi-modal analgesia (SOC+peri-operative celecoxib, SOC+peri-operative gabapentin, and SOC+post-operative zopiclone). The investigators hypothesize that administration of multi-modal analgesia in all three treatment groups will result in improved post-operative pain control, reduced post-operative narcotic consumption and an overall reduction in post-operative length-of-stay compared to the group receiving treatment as per the standard of care. However, prior to undertaking a large multi-centre study, the investigators need to determine whether the study is feasible from data obtained with this pilot study.

Conditions

Hip Pain Chronic

Keywords

Hip Arthroscopy

Outcome Measures

Primary Outcomes (1)

• Change in Pain Score

  Visual Analog Scale 0-100 to determine daily hip pain; 0=extreme pain, 100=no pain

  Baseline, 1, 2, 6, 24hr post-op, daily for 1 week, every other day for 6 weeks

Secondary Outcomes (5)

• Change in Patient Satisfaction

  Daily for 1 week, every other day for 6 weeks

• Change in Length of Stay

  24 hrs

• Change in Post-operative Complication Rates

  24 hours

• Change in Post-operative Narcotic Consumption

  2 weeks

• Cost Diary

  Weekly for 6 weeks

Study Arms (4)

Group 1

ACTIVE COMPARATOR

Oxycodone-acetaminophen 5 mg/325 mg, 1-2 tabs every 6 hours as needed for 60 tabs Naprosyn 500 mg twice daily x 3 weeks

Drug: Percocet; Drug: Naprosyn

Group 2

EXPERIMENTAL

Oxycodone-acetaminophen 5 mg/325 mg, 1-2 tabs every 6 hours as needed for 60 tabs Naprosyn 500 mg twice daily for 3 weeks Zopiclone 7.5 mg nightly for 7 days

Drug: Zopiclone; Drug: Percocet; Drug: Naprosyn

Group 3

EXPERIMENTAL

Oxycodone-acetaminophen 5 mg/325 mg, 1-2 tabs every 6 hours as needed for 60 tabs Naprosyn 500 mg twice daily for 3 weeks Gabapentin 600 mg pre-operatively for one dose and 600 mg post-operatively for one dose

Drug: Gabapentin; Drug: Percocet; Drug: Naprosyn

Group 4

EXPERIMENTAL

Oxycodone-acetaminophen 5 mg/325 mg, 1-2 tabs every 6 hours as needed for 60 tabs Naprosyn 500 mg twice daily for 3 weeks Celebrex 400 mg pre-operatively for one dose

Drug: Celebrex; Drug: Percocet; Drug: Naprosyn

Interventions

Zopiclone DRUG

Group 2 - Zopiclone 7.5 mg orally, nightly for 7 days

Group 2

Gabapentin DRUG

Group 3 - Gabapentin 600 mg orally, 1 hour pre-operatively and 600 mg orally, 8 hours post-operatively

Group 3

Celebrex DRUG

Group 4 - Celebrex 400 mg PO, 1 hour pre-operatively

Group 4

Percocet DRUG

Standard of Care

Group 1; Group 2; Group 3; Group 4

Naprosyn DRUG

Standard of Care

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• any patient between the ages of 18 and 60 years undergoing hip arthroscopy by one of three fellowship-trained hip arthroscopists

You may not qualify if:

• radiographic signs of osteoarthritis (Tönnis grade 2 or higher), an American Society of Anesthesiologists (ASA) classification of 3 or higher,
• allergy to sulfa-based drugs,
• adverse reactions to any of the potential study medications, or a
• history of chronic pain, substance abuse or
• pregnancy

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

Fowler Kennedy Sport Medicine Clinic

London, Ontario, N6A 3K7, Canada

Location

MeSH Terms

Interventions

zopiclone; Gabapentin; Celecoxib; oxycodone-acetaminophen; Naproxen

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Benzenesulfonamides; Sulfonamides; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Ryan Degen, MD, FRCSC

  Fowler Kennedy Sport Medicine Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: November 22, 2017
• Study Start: April 6, 2018
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: October 15, 2021

Record last verified: 2021-10

Locations

CA (1)