Comparison of Anesthetic Techniques on Total Hip Arthroplasty

NCT01359865 | Terminated DMC

• 1 other identifier: MSHersheyMC
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

To compare analgesia and orthopedic rehabilitation milestones in patients receiving either spinal anesthesia (local anesthetic plus opioid) or general endotracheal anesthesia with lumbar plexus block.

Conditions

Osteoarthritis

Keywords

Total hip arthroplasty; lumbar plexus block; spinal anesthesia; range of motion; Anesthetic Technique; Post-operative Pain Scores

Outcome Measures

Primary Outcomes (1)

• To compare analgesia and orthopedic rehabilitation milestones (range of motion) in patients receiving either spinal anesthesia (local anesthetic plus opioid) or general endotracheal anesthesia with lumbar plexus block.

  On arrival to the adult orthopedic/joint reconstruction ward, a physical therapist will assess the range of motion and document the findings in Powerchart using a pre-existing template. This will be the main primary outcome measure along with ongoing pain scale as part of the orthopedic rehabilitation milestones.

  Approx one to three month post-op

Study Arms (1)

Lumbar plexus Block

NO INTERVENTION

This group will recieve pre-operative lumbar plexus block plus general anesthesia

Procedure: Lumbar Plexus Block

Interventions

Lumbar Plexus Block PROCEDURE

lumbar plexus block followed by a general anesthetic. The lumbar plexus block will be performed by an attending anesthesiologist using ultrasound guidance (for measuring the depth of the psoas compartment) and nerve stimulation. A standardized block solution of 30 mL 0.5% ropivacaine will be injected in fractionated doses when a quadriceps muscle twitch is present to nerve stimulation at \<0.50 mA. Fifteen minutes after block completion, the block's effectiveness will be evaluated with an ice test.

Lumbar plexus Block

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective primary THA
• Surgery by Dr. Fenwick and Dr. Raab
• Anesthesia clinic pre-operative appointment
• ASA I, II, III

You may not qualify if:

• Revision THA
• Prior THA on opposite side
• Traumatic hip injury
• Contraindication to neuraxial or regional anesthesia
• History of post-operative nausea and vomiting \> 2 prior general anesthetics
• Allergy to local anesthetics, morphine, hydromorphone, dexamethasone, or ondansetron
• History of substance abuse or chronic narcotic use
• Severe degenerative joint disease to non-operative joint impairing ambulation
• Severe back pain or spinal cord stenosis limiting ambulation
• BMI \> 40

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• John Anson, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assitant professor of Anesthesiology

Study Record Dates

• First Submitted: May 23, 2011
• First Posted: May 25, 2011
• Study Start: July 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: July 1, 2013
• Last Updated: October 2, 2015

Record last verified: 2015-09

Locations

US (1)