Comparison of Anesthetic Techniques on Total Hip Arthroplasty

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Milton S. Hershey Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Jonathan Anson, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01359865
First received: May 23, 2011
Last updated: April 22, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Osteoarthritis
Procedure: Lumbar Plexus Block

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Influence of Anesthetic Technique on Post-operative Pain Scores and Range of Motion in Primary Total Hip Arthroplasty

Resource links provided by NLM:


Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • 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. [ Time Frame: Approx one to three month post-op ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 70
Study Start Date: July 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Lumbar plexus Block
This group will recieve pre-operative lumbar plexus block plus general anesthesia
Procedure: Lumbar Plexus Block
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.

Detailed Description:

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.

: Total hip arthroplasty (THA) is a common surgery worldwide. Despite the prevalence of this procedure, there is no "gold standard" anesthetic. Several different techniques are utilized. The two most common anesthesia modalities are: 1) spinal anesthesia 2) general anesthesia (with or without a peripheral nerve block). The choice of anesthetic technique is often based on the training and experience of the anesthesia provider, as well as the culture of the institution. Both spinal anesthesia (consisting of local anesthetic and opioid) and general anesthesia (combined with lumbar plexus nerve block) can provide adequate intra-operative anesthesia as well as prolonged post-operative analgesia. The goal of this study is to determine if the choice of one of these two anesthetic techniques influences postoperative pain scores and orthopedic rehabilitation markers in patients undergoing primary THA.

Several studies have compared spinal versus general anesthesia in terms of post-operative pain relief, nausea and vomiting, blood loss, and deep venous thrombosis. Most of these studies did not utilize a lumbar plexus nerve block for postoperative analgesia in the general anesthesia subjects. The investigators are not aware of any randomized, controlled studies examining differences in orthopedic outcomes when THA is performed under spinal anesthesia or general anesthesia with lumbar plexus nerve block. These two anesthetic techniques result in different degrees of intraoperative muscle relaxation which may affect post-operative range of motion. Analgesic differences between the two techniques may also affect range of motion and post-operative ambulation.

The investigators propose to compare post-operative pain scores as a primary outcome in patients receiving either spinal anesthesia (bupivicaine with morphine) or general anesthesia with lumbar plexus block for THA. Orthopedic outcomes, including distance of first ambulation, physical therapy range of motion, and limb length discrepancies will be measured as secondary outcomes. Continuous pulse oximetry and capnograpahy data will be recorded for 24 hours postoperatively on all patients. The incidence of urinary tract infections and post-operative nausea and vomiting between groups will be additional measured outcomes.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01359865

Contacts
Contact: John Anson, MD 717-531-0000 janson@hmc.psu.edu
Contact: David Owen, DO 717-531-0000 dowen@hmc.psu.edu

Locations
United States, Pennsylvania
Penn State Hershey Medical Center Not yet recruiting
Hershey, Pennsylvania, United States, 17033
Contact: John Anson, MD    717-531-0000    janson@hmc.psu.edu   
Contact: David Owen, DO    717-531-0000    dowen@hmc.psu.edu   
Principal Investigator: John Anson, MD         
Penn State Hershey Medical Center Not yet recruiting
Hershey, Pennsylvania, United States, 17033
Contact: John Anson, MD    717-531-0000    janson@hmc.psu.edu   
Contact: David Owen, DO    717-531-0000    dowen@hmc.psu.edu   
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Principal Investigator: John Anson, MD Milton S. Hershey Medical Center
  More Information

No publications provided

Responsible Party: Jonathan Anson, Assitant professor of Anesthesiology, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01359865     History of Changes
Other Study ID Numbers: MSHersheyMC
Study First Received: May 23, 2011
Last Updated: April 22, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Milton S. Hershey Medical Center:
Total hip arthroplasty
lumbar plexus block
spinal anesthesia
range of motion
Anesthetic Technique
Post-operative Pain Scores

Additional relevant MeSH terms:
Osteoarthritis
Pain, Postoperative
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 14, 2014