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

May 23, 2011
April 22, 2012
July 2012
May 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01359865 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Comparison of Anesthetic Techniques on Total Hip Arthroplasty
The Influence of Anesthetic Technique on Post-operative Pain Scores and Range of Motion in Primary Total Hip Arthroplasty

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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Osteoarthritis
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.
No Intervention: Lumbar plexus Block
This group will recieve pre-operative lumbar plexus block plus general anesthesia
Intervention: Procedure: Lumbar Plexus Block
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
70
July 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
Not Provided
Yes
Contact: John Anson, MD 717-531-0000 janson@hmc.psu.edu
Contact: David Owen, DO 717-531-0000 dowen@hmc.psu.edu
United States
 
NCT01359865
MSHersheyMC
Yes
Jonathan Anson, Milton S. Hershey Medical Center
Milton S. Hershey Medical Center
Not Provided
Principal Investigator: John Anson, MD Milton S. Hershey Medical Center
Milton S. Hershey Medical Center
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP