Low Dose Extended-release Epidural and Lumbar Plexus Block Compared to Lumbar Plexus Block for Total Hip Resurfacing

NCT00934661 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: IRB00006969
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

At Wake Forest University, the investigators have been using Extended Release Epidural Morphine (EREM), since late 2004, as part of multimodal analgesia in patients having gynecologic surgeries and hip arthroplasties. Hypothesis: In patients undergoing a Birmingham total hip arthroplasty (BHA), low dose EREM in conjunction with lumbar plexus block (LPB) will be better than lumbar plexus block alone in increasing proportion of patients who meet discharge criteria within 24 hours.

Conditions

Hip Arthroplasty

Keywords

hip resurfacing; hip arthroplasty

Outcome Measures

Primary Outcomes (1)

• Length of Hospital Stay After Surgery

  From surgery day to hospital discharge, up to 4 days

Secondary Outcomes (7)

• Total Opioid Consumption

  96 hours

• Patient Satisfaction Score

  96 hours

• Distance Walked at Walking Test

  96 hours

• Verbal Pain Scores Post-gait

  1 day post surgery

• Verbal Pain Scores Post-gait

  2 Days Post Surgery

Study Arms (2)

Extended Release Epidural Morphine

EXPERIMENTAL

Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline

Drug: Extended Release Epidural Morphine (EREM)

Placebo Group

PLACEBO COMPARATOR

The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush

Drug: Placebo

Interventions

Extended Release Epidural Morphine (EREM) DRUG

A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline

Also known as: Depodur

Extended Release Epidural Morphine

Placebo DRUG

A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush

Also known as: preservative free normal saline, sodium chloride

Placebo Group

Eligibility Criteria

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

You may qualify if:

• A primary unilateral Birmingham hip arthroplasty
• Men and women 18-65 years

You may not qualify if:

• Refusal of regional anesthesia
• Laboratory evidence of coagulopathy (platelet count less than 100,000 cells/microliter of blood, prothrombin time greater than 12.1 seconds, partial thromboplastin time greater than 30 seconds, or international normalized ratio of greater than 1.5)
• Allergy to morphine
• Obstructive sleep apnea
• Body mass index (BMI) greater than 40 kg/m2
• Pregnant or lactating
• Severe renal or hepatic disease

Sponsors & Collaborators

• Wake Forest University: lead
• EKR Therapeutics, Inc: collaborator

Study Sites (1)

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Pamela Nagle Assistant Professor
• Organization: Anesthesiology

336-716-7180

Study Officials

• Pamela C Nagle, M.D.

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2009
• First Posted: July 8, 2009
• Study Start: January 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: September 12, 2018
• Results First Posted: January 16, 2018

Record last verified: 2018-09

Locations

US (1)