NCT04169113

Opiate Prescribing Guidelines Following Hip Arthroscopy

Completed NA Results posted Last updated 5 October 2020

What this trial tests

NA trial testing Group 1 - Opiate Tablets post Hip Arthroscopy in Hip Injuries in 111 participants. Completed in 8 July 2020.

Timeline

12 June 2018

Primary endpoint
21 February 2020

8 July 2020

Quick facts

Lead sponsor	Northwestern University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	111
Start date	12 June 2018
Primary completion	21 February 2020
Estimated completion	8 July 2020
Sites	1 location across United States

Drugs / interventions tested

• Group 1 - Opiate Tablets post Hip Arthroscopy
• Group 2 - Opiate Tablets post Hip Arthroscopy

Conditions studied

• Hip Injuries — all drugs for Hip Injuries →

Sponsor

Northwestern University

Who can join

Adults 18 to 89, any sex, with Hip Injuries. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Numeric Pain Rating Scale (NPRS) Pain Scores Primary · Baseline (pre-operative)

minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient

Group	Value	95% CI
Group 1 (60) - Hip Arthroscopy	4.2	± 2.6
Group 2 (30) - Hip Arthroscopy	4.0	± 1.7

Numeric Pain Rating Scale (NPRS) Pain Scores Primary · 2 hours post-operative

minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient

Group	Value	95% CI
Group 1 (60) - Hip Arthroscopy	5.0	± 2.1
Group 2 (30) - Hip Arthroscopy	4.7	± 2.1

Numeric Pain Rating Scale (NPRS) Pain Scores Primary · 24 hours post-operative

minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient

Group	Value	95% CI
Group 1 (60) - Hip Arthroscopy	3.9	± 2.5
Group 2 (30) - Hip Arthroscopy	3.8	± 2.3

Numeric Pain Rating Scale (NPRS) Pain Scores Primary · 48 hours post-operative

minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient

Group	Value	95% CI
Group 1 (60) - Hip Arthroscopy	3.2	± 2.4
Group 2 (30) - Hip Arthroscopy	3.3	± 2.1

Numeric Pain Rating Scale (NPRS) Pain Scores Primary · 7 days post-operative

minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient

Group	Value	95% CI
Group 1 (60) - Hip Arthroscopy	2.3	± 2.4
Group 2 (30) - Hip Arthroscopy	2.2	± 1.6

Opiates Taken Primary · 24 hours post-operative

Number of prescribed narcotic pills taken in the preceding time period

Group	Value	95% CI
Group 1 (60) - Hip Arthroscopy	3.0	± 2.2
Group 2 (30) - Hip Arthroscopy	2.4	± 2.5

Opiates Taken Primary · 48 hours post-operative

Number of prescribed narcotic medication tablets taken in the preceding time period

Group	Value	95% CI
Group 1 (60) - Hip Arthroscopy	5.2	± 5.7
Group 2 (30) - Hip Arthroscopy	4.9	± 5.9

Opiates Taken Primary · 7 days post-operative

Number of prescribed narcotic medication tablets taken in the preceding time period

Group	Value	95% CI
Group 1 (60) - Hip Arthroscopy	10.4	± 15.9
Group 2 (30) - Hip Arthroscopy	8.8	± 9.3

Opiates Taken Primary · 21 days post-operative

Number of prescribed narcotic medication tablets taken in the preceding time period

Group	Value	95% CI
Group 1 (60) - Hip Arthroscopy	10.5	± 16.5
Group 2 (30) - Hip Arthroscopy	9.2	± 11.1

Opiates Remaining Primary · 24 hours post-operative

Number of prescribed narcotic medication tablets remaining from initial amount prescribed

Group	Value	95% CI
Group 1 (60) - Hip Arthroscopy	57.0	± 2.2
Group 2 (30) - Hip Arthroscopy	27.6	± 2.5

Opiates Remaining Primary · 48 hours post-operative

Number of prescribed narcotic medication tablets remaining from initial amount prescribed

Group	Value	95% CI
Group 1 (60) - Hip Arthroscopy	54.8	± 5.7
Group 2 (30) - Hip Arthroscopy	25.1	± 5.9

Opiates Remaining Primary · 7 days post-operative

Number of prescribed narcotic medication tablets remaining from initial amount prescribed

Group	Value	95% CI
Group 1 (60) - Hip Arthroscopy	49.6	± 15.9
Group 2 (30) - Hip Arthroscopy	22.3	± 8.4

Sponsor's own description

The purpose of the study is to determine if opiates are required to achieve appropriate analgesia after hip arthroscopy in outpatient surgery. The investigators hypothesize that patients are frequently prescribed more opiates than are needed after surgery, resulting in excess medications that are at risk for misuse, diversion and contribution to the opioid epidemic

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.