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Comparison of Anesthetic Techniques on Total Hip Arthroplasty

Primary Purpose

Osteoarthritis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lumbar Plexus Block
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Total hip arthroplasty, lumbar plexus block, spinal anesthesia, range of motion, Anesthetic Technique, Post-operative Pain Scores

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Penn State Hershey Medical Center

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

Lumbar plexus Block

Arm Description

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

Outcomes

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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 23, 2011
Last Updated
September 30, 2015
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01359865
Brief Title
Comparison of Anesthetic Techniques on Total Hip Arthroplasty
Official Title
The Influence of Anesthetic Technique on Post-operative Pain Scores and Range of Motion in Primary Total Hip Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Why Stopped
change in clinical practice- both surgeons have left the institution
Study Start Date
July 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Total hip arthroplasty, lumbar plexus block, spinal anesthesia, range of motion, Anesthetic Technique, Post-operative Pain Scores

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lumbar plexus Block
Arm Type
No Intervention
Arm Description
This group will recieve pre-operative lumbar plexus block plus general anesthesia
Intervention Type
Procedure
Intervention Name(s)
Lumbar Plexus Block
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Approx one to three month post-op

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Anson, MD
Organizational Affiliation
Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

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Comparison of Anesthetic Techniques on Total Hip Arthroplasty

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