NCT03199157

Brief Summary

The investigators designed a prospective randomized study to investigate the effect of fentanyl 12 mcg transdermal patch on postoperative pain following unilateral, single-level laminectomy/discectomy.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for phase_4 postoperative-pain

Timeline
Completed

Started Mar 2015

Typical duration for phase_4 postoperative-pain

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 26, 2017

Completed
Last Updated

June 26, 2017

Status Verified

June 1, 2017

Enrollment Period

1.5 years

First QC Date

June 23, 2017

Last Update Submit

June 23, 2017

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Numeric rating score for pain (NRS)

    Postoperative 24 hours

Study Arms (2)

Fentanyl Group

ACTIVE COMPARATOR

Patients received the fentanyl 12 mcg transdermal patch (FG, n=38) 8 hours preoperatively and until 24 hours after the surgery

Drug: Fentanyl transdermal patch

Control group

NO INTERVENTION

Interventions

Fentanyl transdermal patchDRUG

Patients received fentanyl 12 mcg transdermal patch group 8 hours preoperatively and until 24 hours after the surgery

Fentanyl Group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients between the ages of 20-70 years
  • ASA physical status 1-2 patients undergoing single-level laminectomy/discectomy

You may not qualify if:

  • A history of allergy to any study drugs
  • History of opioid use, obstructive sleep apnea
  • Any psychological disorders
  • hepatic or renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

June 23, 2017

First Posted

June 26, 2017

Study Start

March 1, 2015

Primary Completion

September 1, 2016

Study Completion

December 1, 2016

Last Updated

June 26, 2017

Record last verified: 2017-06