Postoperative PainPhase 4LPB Hip ScopeNCT01286805
Lumbar Plexus Block for Postoperative Pain Control After Hip Arthroscopy. A Randomized Controlled Trial
A Phase 4 study testing Lumbar Plexus Blockade in people with Postoperative Pain, run by Hospital for Special Surgery, New York at 2 sites in United States.
Trial summary
The purpose of this study is to determine whether the use of a lumbar plexus block for arthroscopic hip surgery is superior to oral and intravenous opioid pain medications alone in treating pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Lumbar Plexus Blockade
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2010to May 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) Class 1-3
- Patients aged 18 to 65 years
- Patients scheduled for primary, unilateral arthroscopic hip surgery by Dr. Kelly, Dr. Coleman, or Dr. Anil Ranawat
- Planned use of neuraxial anesthesia
- Body Mass Index less than 35
- Ability to follow study protocol
Who cannot join
- Chronic opioid use (defined as daily or almost daily use of opioids for >3 months)
- Contraindication to combined spinal-epidural anesthesia including but not limited to bleeding disorder, use of clinically relevant anticoagulant or antiplatelet medications, and anatomic abnormalities.
- Contraindication to lumbar plexus block including but not limited to bleeding disorder, use of clinically relevant anticoagulant or antiplatelet medications, and anatomic abnormalities.
- Infection at the injection site(s)
- Allergy to any of the study medications
- Contraindication to a short course of NSAIDs (renal failure, intolerance)
Show all 12Show fewer
- ASA Class 4-5
- Patient refusal
- Patients younger than 18 years old and older than 65
- Patients with any known indwelling hardware of the lumbar spine.
- Patients with a peripheral neuropathy of the surgical extremity
- Non-English speaking patients
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hospital for Special Surgery
New York, New York, 10021
New York Presbyterian Hospital
New York, New York, 10065
About this study
The purpose of this study is to determine whether the use of a lumbar plexus block for arthroscopic hip surgery is superior to oral and intravenous opioid pain medications alone in treating pain. In addition, the study will examine whether lumbar plexus blocks reduce the total amount of pain medication needed, and therefore reduce the side effects of these medicines and increase patient satisfaction. It is hypothesized that addition of the lumbar plexus block will significantly reduce patients' postoperative pain.
- Conditions
- Postoperative Pain
- Being tested
- Lumbar Plexus Blockade, Control
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar Plexus BlockadeProcedure or surgery
Also called Marcaine
The lumbar plexus block will be dosed with 30 milliliters of 0.25% bupivacaine with 1:200,000 epinephrine
ControlProcedure or surgery
The control group will receive only a combined spinal-epidural.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar Plexus Blockade + CSE | Experimental | The study group will receive a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural. Receives: Procedure: Lumbar Plexus Blockade |
| Control Group | Placebo comparator | The control group will receive only a combined spinal-epidural. Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale (NRS) Pain at Rest (0-10) on Day of Surgery Prior to Discharge
The Numeric Rating Scale was used to ask patients to rate their pain at rest on a scale of 0 to 10, 0 = no pain and 10 = worst pain imaginable.
Measured: Day of surgery prior to discharge
Secondary outcomes (7)
Readiness to Discharge From Post-Anesthesia Care Unit (PACU)
Time to readiness for discharge from the PACU. Patients were considered ready for PACU discharge when they met the following criteria: a) Awake, alert, oriented and responsive b) Minimal pain, Numeric Rating Scale < 5/10 (0 = no pain, 10 = worst imaginable pain) (parenteral [injected] medications not required) c) Vital signs stable d) No active bleeding e) Minimal or no nausea f) Not vomiting, tolerating oral intake g) Oxygen saturation > 94% (or baseline) on room air h) Patient has urinated.
Measured: Day of surgery prior to discharge
Narcotic Pain Medication Needed
Measured: Day of surgery prior to discharge
Incidence of Nausea
The number of participants with nausea.
Measured: Day of surgery prior to discharge
Incidence of Vomiting
The number of participants who vomited.
Measured: Day of surgery prior to discharge
Requirement of Antiemetic Rescue
The number of participants who needed medication to treat their nausea and vomiting.
Measured: Day of surgery prior to discharge
Patient Satisfaction
Patient Satisfaction (0-10; 0 = very dissatisfied, 10 = very satisfied)
Measured: First 24 hours after surgery
Quality of Recovery (QoR-40) Physical Comfort Dimension
Assessment of Physical Comfort (minimum score = 12, maximum score = 60). Higher values represent a better outcome
Measured: First 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2011 (estimated)
- Study startMay 2010
- Primary completionOct 2010
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Collaborators
- New York Presbyterian Hospital
- Responsible party
- Sponsor
- Investigators
- Jacques T YaDeau, M.D., Ph.D., Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01286805
- Sponsor's protocol ID
- 10038
- Acronym
- LPB Hip Scope
- Status last verified
- May 2013
- First submitted
- 28 Jan 2011
- Last updated
- 5 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumbar Plexus Block for Postoperative Pain Control After Hip Arthroscopy. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01286805
- Acronym / sponsor ID
- LPB Hip Scope / 10038
- Conditions
- Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Collaborators
- New York Presbyterian Hospital
- Study start
- May 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 31 Jan 2011 (estimated)
- Results
- Posted 5 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the use of a lumbar plexus block for arthroscopic hip surgery is superior to oral and intravenous opioid pain medications alone in treating pain. In addition, the study will examine whether lumbar plexus blocks reduce the total amount of pain medication needed, and therefore reduce the side effects of these medicines and increase patient satisfaction. It is hypothesized that addition of the lumbar plexus block will significantly reduce patients' postoperative pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumbar Plexus Blockade + CSE | Experimental | Procedure: Lumbar Plexus BlockadeThe study group will receive a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural. |
| Control Group | Placebo comparator | Procedure: ControlThe control group will receive only a combined spinal-epidural. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- American Society of Anesthesiologists (ASA) Class 1-3
- Patients aged 18 to 65 years
- Patients scheduled for primary, unilateral arthroscopic hip surgery by Dr. Kelly, Dr. Coleman, or Dr. Anil Ranawat
- Planned use of neuraxial anesthesia
- Body Mass Index less than 35
Key exclusion criteria (12 listed)
- Chronic opioid use (defined as daily or almost daily use of opioids for >3 months)
- Contraindication to combined spinal-epidural anesthesia including but not limited to bleeding disorder, use of clinically relevant anticoagulant or antiplatelet medications, and anatomic abnormalities.
- Contraindication to lumbar plexus block including but not limited to bleeding disorder, use of clinically relevant anticoagulant or antiplatelet medications, and anatomic abnormalities.
- Infection at the injection site(s)
- Allergy to any of the study medications
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 BlockadeAlso: MarcaineThe lumbar plexus block will be dosed with 30 milliliters of 0.25% bupivacaine with 1:200,000 epinephrine | Procedure or surgery | Lumbar Plexus Blockade + CSE |
| ControlThe control group will receive only a combined spinal-epidural. | Procedure or surgery | Control Group |
Primary outcome
Numeric Rating Scale (NRS) Pain at Rest (0-10) on Day of Surgery Prior to Discharge
Time frame: Day of surgery prior to discharge
The Numeric Rating Scale was used to ask patients to rate their pain at rest on a scale of 0 to 10, 0 = no pain and 10 = worst pain imaginable.
7 secondary outcomes
Readiness to Discharge From Post-Anesthesia Care Unit (PACU)
Time frame: Day of surgery prior to discharge
Narcotic Pain Medication Needed
Time frame: Day of surgery prior to discharge
Incidence of Nausea
Time frame: Day of surgery prior to discharge
Incidence of Vomiting
Time frame: Day of surgery prior to discharge
Requirement of Antiemetic Rescue
Time frame: Day of surgery prior to discharge
Patient Satisfaction
Time frame: First 24 hours after surgery
Quality of Recovery (QoR-40) Physical Comfort Dimension
Time frame: First 24 hours after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- This is the link for the Hospital for Special Surgery websiteLink provided by the sponsor.
Related trials for Postoperative Pain
Recruiting
Radiofrequency Ablation for the Treatment of Post-knee Arthroplasty Chronic Pain.
Chronic Post-surgical Pain, Chronic Post Operative Pain
Recruiting
Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery
Postoperative Pain, Facial Swelling
RecruitingPhase 4
Anrikefon-based Patient-controlled Intravenous Analgesia Following Laparoscopic Surgery
Laparoscopic Surgery, Visceral Pain, Postoperative
Recruiting
Lateral QL Block vs Intrathecal Morphine for Cesarean Section
Anesthesia, Postoperative Pain
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
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.
Jacques T YaDeau, M.D., Ph.D. principal investigator
Hospital for Special Surgery, New York
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lumbar Plexus Blockade in people with Postoperative Pain, run by Hospital for Special Surgery, New York at 2 sites 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 6 inclusion and 12 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: finished, as of the sponsor's last update on 5 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Numeric Rating Scale (NRS) Pain at Rest (0-10) on Day of Surgery Prior to Discharge (time frame: Day of surgery prior to discharge). 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 5 Jun 2013; AzTrials last refreshed its copy on 31 Oct 2026.