Single Shot Versus OnQ Pump in Extremity Fractures

NCT02280291 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 12-03598
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Peripheral nerve blocks have been well studied in the literature with generally good results for controlling post operative pain following orthopaedic surgery. Regional anesthesia has many benefits. It provides excellent intraoperative anesthesia and muscle relaxation as well as analgesia that continues into the post-operative period. These regional blocks are also effective in controlling pain in the immediate post-operative period. However, as the block wears off, patients begin experiencing increased pain. Compared to patients treated without regional blocks, these patients will often experience a "rebound pain"--pain occurring 12-24 hours after surgery that is subjectively worse than that in patients treated without regional blocks. Therefore, the investigators propose to use a continuous infusion of anesthetic in order to provide sustained pain control post-operatively. Preoperatively, patients will be randomized into a single shot peripheral nerve block versus a continuous infusion of peripheral nerve block. Post-operatively, pain will be assessed using the Visual Analogue Scale (1-100) prior to being discharged from PACU. Time to discharge and amount of pain medication taken will be recorded. Patients will be contacted at certain time intervals postoperatively to assess their pain scale and pain medication intake. Patients will be seen for routine post-operative follow-up visits where they will be assessed for satisfaction, pain, residual neurological symptoms, and signs of infection.

Conditions

Pain; Fracture

Outcome Measures

Primary Outcomes (1)

• Change in Score on Visual Analog Scale (VAS)

  The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0 ("no pain") and 10 ("worst pain").

  2 weeks, 6 weeks

Secondary Outcomes (1)

• Disability of the Arm, Shoulder and Hand (DASH) Score

  2 Weeks, 6 Weeks

Study Arms (4)

Ankle Single Shot Block (SSB)

ACTIVE COMPARATOR

Drug: Ankle SSB

Ankle OnQ (Continuos Sedation OnQ Pump)

EXPERIMENTAL

Drug: Ankle OnQ

DR SSB

EXPERIMENTAL

Drug: DR SSB

DR OnQ

EXPERIMENTAL

Drug: DR OnQ

Interventions

Ankle SSB DRUG

general anesthesia/sedation with a single shot; Primary predictor variable: single shot block, a 22 gauge, 3.5 inch needle will be used and 20cc of 2% lidocaine with 1:200,000 epinephrine + 20cc of 0.5% bupivacaine with 1:300,000 epinephrine will be injected around the nerve after confirming negative aspiration every 5 cc.

Ankle Single Shot Block (SSB)

Ankle OnQ DRUG

versus regional block with continuous infusion using an OnQ pump. 17 gauge Tuohy needle will be used and 20cc of 2% lidocaine with epinephrine +20cc of 0.5% bupivacaine with1:300,000epinephrine will be injected around the nerve after confirming negative aspiration every 5cc.

Ankle OnQ (Continuos Sedation OnQ Pump)

DR SSB DRUG

general anesthesia/sedationwith a single shot; general anesthesia/sedation with a single shot; Primary predictor variable: single shot block, a 22 gauge, 3.5 inch needle will be used and 20cc of 2% lidocaine with 1:200,000 epinephrine + 20cc of 0.5% bupivacaine with 1:300,000 epinephrine will be injected around the nerve after confirming negative aspiration every 5 cc.

DR SSB

DR OnQ DRUG

versus regional block with continuous infusion using an OnQ pump. 17 gauge Tuohy needle will be used and 20cc of 2% lidocaine with epinephrine +20cc of 0.5% bupivacaine with1:300,000epinephrine will be injected around the nerve after confirming negative aspiration every 5cc.

DR OnQ

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients at least 18 years old.
• Male or Female
• All racial and ethnic groups
• Fractures and fracture/dislocations of the foot, ankle, tibia, fibula, elbow, forearm, wrist and hand
• Patients who opt for surgical treatment of their fractures.
• Patients who consent to be randomized.
• Patients who are willing to follow-up for a minimum of 52 weeks.

You may not qualify if:

• Patients younger than 18 years old.
• Patients who are on chronic opioids
• Patients who abuse opioids
• Patients who are unwilling to follow-up for a minimum of 52 weeks.
• Neurologic condition that could interfere with pain sensation

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

Hospital for Joint Diseases

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Pain; Fractures, Bone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Results Point of Contact

• Title: Nirmal Tejwani
• Organization: NYU Langone Health

Nirmal.Tejwani@nyulangone.org

212 598 6599

Study Officials

• Nirmal Tejwani, MD

  NYU Hospital for Joint Diseases

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2014
• First Posted: October 31, 2014
• Study Start: August 1, 2013
• Primary Completion: December 13, 2018
• Study Completion: December 13, 2018
• Last Updated: March 30, 2020
• Results First Posted: March 30, 2020

Record last verified: 2020-03

Locations

US (1)