Comparison of Anesthetic Techniques on Total Hip Arthroplasty

NCT ID: NCT01359865

Last Updated: 2015-10-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2013-07-31

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Lumbar plexus Block

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

Group Type: NO_INTERVENTION

Lumbar Plexus Block

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Anson

Assitant professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John Anson, MD

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Locations

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States

Countries

United States

Other Identifiers

MSHersheyMC

Identifier Type: -

Identifier Source: org_study_id