OsteoarthritisNCT01359865
Comparison of Anesthetic Techniques on Total Hip Arthroplasty
A study testing Lumbar Plexus Block in people with Osteoarthritis, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Lumbar Plexus Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Elective primary THA
- Surgery by Dr. Fenwick and Dr. Raab
- Anesthesia clinic pre-operative appointment
- ASA I, II, III
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: 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.
Read the 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
- Being tested
- Lumbar Plexus Block
- Keywords
- Total hip arthroplasty, lumbar plexus block, spinal anesthesia, range of motion, Anesthetic Technique, Post-operative Pain Scores
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar Plexus BlockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar plexus Block | No intervention | This group will recieve pre-operative lumbar plexus block plus general anesthesia Receives: Procedure: Lumbar Plexus Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approx one to three month post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2011 (estimated)
- Study startJul 2012
- Primary completionMay 2013
- Study completionJul 2013
Why it stopped: change in clinical practice- both surgeons have left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Anson, Milton S. Hershey Medical Center
- Investigators
- John Anson, MD, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359865
- Sponsor's protocol ID
- MSHersheyMC
- Status last verified
- Sep 2015
- First submitted
- 23 May 2011
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Anesthetic Technique on Post-operative Pain Scores and Range of Motion in Primary Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT01359865
- Acronym / sponsor ID
- MSHersheyMC
- Conditions
- Osteoarthritis
- Keywords
- Total hip arthroplasty, lumbar plexus block, spinal anesthesia, range of motion, Anesthetic Technique, Post-operative Pain Scores
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: change in clinical practice- both surgeons have left the institution
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 25 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lumbar plexus Block | No intervention | Procedure: Lumbar Plexus BlockThis group will recieve pre-operative lumbar plexus block plus general anesthesia |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Elective primary THA
- Surgery by Dr. Fenwick and Dr. Raab
- Anesthesia clinic pre-operative appointment
- ASA I, II, III
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbar Plexus Blocklumbar 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. | Procedure or surgery | Lumbar plexus Block |
Primary outcome
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
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.
Results and safety
The study was stopped early (reason given: change in clinical practice- both surgeons have left the institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Anson, MD principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar Plexus Block in people with Osteoarthritis, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: change in clinical practice- both surgeons have left the institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2015.