Anterior Cruciate Ligament RupturePhase 4NCT00022854
Pain Relief Results After Anterior Cruciate Ligament (ACL) Reconstruction
A Phase 4 study testing Single-injection femoral nerve block and Femoral nerve block 60-hour continuous injection in people with Anterior Cruciate Ligament Rupture, run by University of Pittsburgh at 1 site in United States.
Trial summary
Anterior cruciate ligament (ACL) reconstruction is surgery that is done to repair a damaged ligament in the knee. In this study we will look at whether the femoral nerve block, a commonly used method for pain relief after ACL reconstruction, affects the way patients feel after surgery. Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- What is being tested?
- Single-injection femoral nerve block and Femoral nerve block 60-hour continuous injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- May 2001to Jan 2005
- Phase
- Phase 4
- 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 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 14-65
- Undergoing ACL reconstruction at the University of Pittsburgh
- Agrees to spinal anesthesia and consents to one of the three nerve block interventions.
- Agrees to visit the University of Pittsburgh Center for Rehabilitation Services for postoperative physical therapy and rehabilitation (for standardized rehabilitation protocols)
Who cannot join
- Morbid obesity
- Chronic pain syndromes
- Opioid dependence
- Corticosteroid prescriptions
- Tricyclic antidepressant prescriptions
- Tramadol prescriptions
Show all 9Show fewer
- Preexisting neuropathies
- Poorly controlled diabetes mellitus
- Poorly controlled anxiety disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center, Center for Sports Medicine
Pittsburgh, Pennsylvania, 15203
About this study
Official title: Outcomes After ACL Reconstruction: The Effect of Femoral Nerve Block Analgesia
Anterior cruciate ligament (ACL) reconstruction is surgery that is done to repair a damaged ligament in the knee. In this study we will look at whether the femoral nerve block, a commonly used method for pain relief after ACL reconstruction, affects the way patients feel after surgery. We will study recovery during the first week after surgery and also 3-12 weeks after surgery. We will give all patients spinal anesthesia. Some patients will also receive a continuous femoral nerve block for 2 days, or by a single injection. We predict that patients who received the nerve block will have significantly improved pain results, compared to patients who did not receive the nerve block.
Read the detailed description
In this project, we will measure outcomes of anesthesia and pain management for common orthopedic procedures. The influence of nerve block pain management on outcomes after outpatient anterior cruciate ligament (ACL) reconstruction has not been studied, especially the patient's potential to return to societal productivity during the first week after surgery. Therefore, we have designed a randomized clinical trial to study the role of nerve block pain management techniques on patient outcomes during the first week after surgery and on recovery 3-12 weeks after surgery. Our hypothesis is that patients undergoing nerve block analgesia will manifest better self-reported recovery outcomes, physical function outcomes, and objective measures of neuromuscular function.
We will give consenting patients (n=270) undergoing ACL reconstruction conventional spinal anesthesia and will randomize them to receive femoral nerve block analgesia with either a single injection, a continuous infusion for 2 days, or saline placebo. We will use goniometry to test postoperative range of motion in extension to determine whether the quadriceps femoris torque output is impaired. We will compare patient-reported recovery outcomes across treatment groups using three validated health status measures suitable for daily assessment (Verbal Pain Score, SF-8, and the Quality of Recovery [from anesthesia, QoR-40] Score).
We aim to determine the quality of immediate recovery from anesthesia and the extent of reported pain. We will compare the effects of single injection and continuous infusion on femoral nerve analgesia to determine the better dosing strategy for these patients.
- Conditions
- Anterior Cruciate Ligament Rupture
- Being tested
- Single-injection femoral nerve block, Femoral nerve block 60-hour continuous injection, Saline (control) injection into femoral nerve envelope
- Keywords
- ACL, Nerve block, Knee, Outcome survey, Anesthesia, Analgesia, Pain
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-injection femoral nerve blockProcedure or surgery
Nerve block bolus with 30 mL levobupivacaine 0.25%, followed by continuous saline infusion
Femoral nerve block 60-hour continuous injectionProcedure or surgery
Nerve block bolus with 30 mL levobupivacaine 0.25%, followed by continuous infusion (5 mL/hr for 50 hours) of 0.25% levobupivacaine
Saline (control) injection into femoral nerve envelopeProcedure or surgery
Nerve block bolus with 30 mL saline, followed by continuous saline infusion
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Procedure: Saline (control) injection into femoral nerve envelope |
| 2 | Experimental | Nerve block bolus with 30 mL levobupivacaine 0.25%, followed by continuous saline infusion Receives: Procedure: Single-injection femoral nerve block |
| 3 | Experimental | Nerve block bolus with 30 mL levobupivacaine 0.25%, followed by continuous levobupivacaine infusion of 5 mL/hr for 50 hr Receives: Procedure: Femoral nerve block 60-hour continuous injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores during the first week after surgery
Measured: one week
Secondary outcomes (7)
Side effects during the first week after surgery (nausea, vomiting, quality of sleep)
Measured: first week after surgery
Determine the "rebound pain score" after a nerve block wears off
Measured: first week after surgery
Skin reactions to the nerve block catehter dressing
Measured: first week after surgery
Risk of falling
Measured: first week after surgery
Validation of an 8-item outcome survey in comparison to a 40-item "gold standard" outcome survey
Measured: first week after surgery
Study staffing costs before and after the implementation of HIPAA
Measured: the 40 months of study recruitment
Patient-reported general health status, and patient-reported knee function, during the first 12 weeks after surgery
Measured: up to 12 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2001 (estimated)
- Study startMay 2001
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Brian A. Williams, MD, MBA, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00022854
- Sponsor's protocol ID
- K23AR047631
- Other IDs
- K23AR047631, NIAMS-066
- Status last verified
- May 2013
- First submitted
- 14 Aug 2001
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Williams BA, Kentor ML, Williams JP, Figallo CM, Sigl JC, Anders JW, Bear TC, Tullock WC, Bennett CH, Harner CD, Fu FH. Process analysis in outpatient knee surgery: effects of regional and general anesthesia on anesthesia-controlled time. Anesthesiology. 2000 Aug;93(2):529-38. doi: 10.1097/00000542-200008000-00033.
PubMed 10910504Williams BA, Kentor ML, Williams JP, Vogt MT, DaPos SV, Harner CD, Fu FH. PACU bypass after outpatient knee surgery is associated with fewer unplanned hospital admissions but more phase II nursing interventions. Anesthesiology. 2002 Oct;97(4):981-8. doi: 10.1097/00000542-200210000-00034.
PubMed 12357168Williams BA, Kentor ML, Vogt MT, Williams JP, Chelly JE, Valalik S, Harner CD, Fu FH. Femoral-sciatic nerve blocks for complex outpatient knee surgery are associated with less postoperative pain before same-day discharge: a review of 1,200 consecutive cases from the period 1996-1999. Anesthesiology. 2003 May;98(5):1206-13. doi: 10.1097/00000542-200305000-00024.
PubMed 12717143Williams BA, Kentor ML, Vogt MT, Vogt WB, Coley KC, Williams JP, Roberts MS, Chelly JE, Harner CD, Fu FH. Economics of nerve block pain management after anterior cruciate ligament reconstruction: potential hospital cost savings via associated postanesthesia care unit bypass and same-day discharge. Anesthesiology. 2004 Mar;100(3):697-706. doi: 10.1097/00000542-200403000-00034.
PubMed 15108988Williams BA, Kentor ML, Vogt MT, Irrgang JJ, Bottegal MT, West RV, Harner CD, Fu FH, Williams JP. Reduction of verbal pain scores after anterior cruciate ligament reconstruction with 2-day continuous femoral nerve block: a randomized clinical trial. Anesthesiology. 2006 Feb;104(2):315-27. doi: 10.1097/00000542-200602000-00018.
PubMed 16436852Williams BA, Kentor ML, Irrgang JJ, Bottegal MT, Williams JP. Nausea, vomiting, sleep, and restfulness upon discharge home after outpatient anterior cruciate ligament reconstruction with regional anesthesia and multimodal analgesia/antiemesis. Reg Anesth Pain Med. 2007 May-Jun;32(3):193-202. doi: 10.1016/j.rapm.2006.12.002.
PubMed 17543813Williams BA, Bottegal MT, Kentor ML, Irrgang JJ, Williams JP. Rebound pain scores as a function of femoral nerve block duration after anterior cruciate ligament reconstruction: retrospective analysis of a prospective, randomized clinical trial. Reg Anesth Pain Med. 2007 May-Jun;32(3):186-92. doi: 10.1016/j.rapm.2006.10.011.
PubMed 17543812Bost JE, Williams BA, Bottegal MT, Dang Q, Rubio DM. The 8-item Short-Form Health Survey and the physical comfort composite score of the quality of recovery 40-item scale provide the most responsive assessments of pain, physical function, and mental function during the first 4 days after ambulatory knee surgery with regional anesthesia. Anesth Analg. 2007 Dec;105(6):1693-700, table of contents. doi: 10.1213/01.ane.0000287659.14893.65.
PubMed 18042869Williams BA, Kentor ML, Bottegal MT. The incidence of falls at home in patients with perineural femoral catheters: a retrospective summary of a randomized clinical trial. Anesth Analg. 2007 Apr;104(4):1002. doi: 10.1213/01.ane.0000256006.46703.7f. No abstract available.
PubMed 17377133Williams BA, Bolland MA, Orebaugh SL, Bottegal MT, Kentor ML. Skin reactions at the femoral perineural catheter insertion site: retrospective summary of a randomized clinical trial. Anesth Analg. 2007 May;104(5):1309-10. doi: 10.1213/01.ane.0000260353.11142.d4. No abstract available.
PubMed 17456710Williams BA, Bottegal MT, Francis KA, Irrgang JJ, Vogt MT. A post hoc analysis of research study staffing: budgetary effects of the Health Insurance Portability and Accountability Act on research staff work hours during a prospective, randomized clinical trial. Anesthesiology. 2007 Nov;107(5):860-1. doi: 10.1097/01.anes.0000287212.90397.6b. No abstract available.
PubMed 18073577
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes After ACL Reconstruction: The Effect of Femoral Nerve Block Analgesia
- ClinicalTrials.gov ID
- NCT00022854
- Acronym / sponsor ID
- K23AR047631
- Conditions
- Anterior Cruciate Ligament Rupture
- Keywords
- ACL, Nerve block, Knee, Outcome survey, Anesthesia, Analgesia, Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- May 2001
- Study completion
- Jan 2005 (actual)
- First posted
- 16 Aug 2001 (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.
Anterior cruciate ligament (ACL) reconstruction is surgery that is done to repair a damaged ligament in the knee. In this study we will look at whether the femoral nerve block, a commonly used method for pain relief after ACL reconstruction, affects the way patients feel after surgery. We will study recovery during the first week after surgery and also 3-12 weeks after surgery. We will give all patients spinal anesthesia. Some patients will also receive a continuous femoral nerve block for 2 days, or by a single injection. We predict that patients who received the nerve block will have significantly improved pain results, compared to patients who did not receive the nerve block.
Detailed description
In this project, we will measure outcomes of anesthesia and pain management for common orthopedic procedures. The influence of nerve block pain management on outcomes after outpatient anterior cruciate ligament (ACL) reconstruction has not been studied, especially the patient's potential to return to societal productivity during the first week after surgery. Therefore, we have designed a randomized clinical trial to study the role of nerve block pain management techniques on patient outcomes during the first week after surgery and on recovery 3-12 weeks after surgery. Our hypothesis is that patients undergoing nerve block analgesia will manifest better self-reported recovery outcomes, physical function outcomes, and objective measures of neuromuscular function.
We will give consenting patients (n=270) undergoing ACL reconstruction conventional spinal anesthesia and will randomize them to receive femoral nerve block analgesia with either a single injection, a continuous infusion for 2 days, or saline placebo. We will use goniometry to test postoperative range of motion in extension to determine whether the quadriceps femoris torque output is impaired. We will compare patient-reported recovery outcomes across treatment groups using three validated health status measures suitable for daily assessment (Verbal Pain Score, SF-8, and the Quality of Recovery [from anesthesia, QoR-40] Score).
We aim to determine the quality of immediate recovery from anesthesia and the extent of reported pain. We will compare the effects of single injection and continuous infusion on femoral nerve analgesia to determine the better dosing strategy for these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Procedure: Saline (control) injection into femoral nerve envelope |
| 2 | Experimental | Procedure: Single-injection femoral nerve blockNerve block bolus with 30 mL levobupivacaine 0.25%, followed by continuous saline infusion |
| 3 | Experimental | Procedure: Femoral nerve block 60-hour continuous injectionNerve block bolus with 30 mL levobupivacaine 0.25%, followed by continuous levobupivacaine infusion of 5 mL/hr for 50 hr |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age 14-65
- Undergoing ACL reconstruction at the University of Pittsburgh
- Agrees to spinal anesthesia and consents to one of the three nerve block interventions.
- Agrees to visit the University of Pittsburgh Center for Rehabilitation Services for postoperative physical therapy and rehabilitation (for standardized rehabilitation protocols)
Key exclusion criteria (9 listed)
- Morbid obesity
- Chronic pain syndromes
- Opioid dependence
- Corticosteroid prescriptions
- Tricyclic antidepressant prescriptions
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 |
|---|---|---|
| Single-injection femoral nerve blockNerve block bolus with 30 mL levobupivacaine 0.25%, followed by continuous saline infusion | Procedure or surgery | 2 |
| Femoral nerve block 60-hour continuous injectionNerve block bolus with 30 mL levobupivacaine 0.25%, followed by continuous infusion (5 mL/hr for 50 hours) of 0.25% levobupivacaine | Procedure or surgery | 3 |
| Saline (control) injection into femoral nerve envelopeNerve block bolus with 30 mL saline, followed by continuous saline infusion | Procedure or surgery | 1 |
Primary outcome
Pain scores during the first week after surgery
Time frame: one week
7 secondary outcomes
Side effects during the first week after surgery (nausea, vomiting, quality of sleep)
Time frame: first week after surgery
Determine the "rebound pain score" after a nerve block wears off
Time frame: first week after surgery
Skin reactions to the nerve block catehter dressing
Time frame: first week after surgery
Risk of falling
Time frame: first week after surgery
Validation of an 8-item outcome survey in comparison to a 40-item "gold standard" outcome survey
Time frame: first week after surgery
Study staffing costs before and after the implementation of HIPAA
Time frame: the 40 months of study recruitment
Patient-reported general health status, and patient-reported knee function, during the first 12 weeks after surgery
Time frame: up to 12 weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2013.
- Background: PubMed 10910504Williams BA, Kentor ML, Williams JP, Figallo CM, Sigl JC, Anders JW, Bear TC, Tullock WC, Bennett CH, Harner CD, Fu FH. Process analysis in outpatient knee surgery: effects of regional and general anesthesia on anesthesia-controlled time. Anesthesiology. 2000 Aug;93(2):529-38. doi: 10.1097/00000542-200008000-00033.
- Background: PubMed 12357168Williams BA, Kentor ML, Williams JP, Vogt MT, DaPos SV, Harner CD, Fu FH. PACU bypass after outpatient knee surgery is associated with fewer unplanned hospital admissions but more phase II nursing interventions. Anesthesiology. 2002 Oct;97(4):981-8. doi: 10.1097/00000542-200210000-00034.
- Background: PubMed 12717143Williams BA, Kentor ML, Vogt MT, Williams JP, Chelly JE, Valalik S, Harner CD, Fu FH. Femoral-sciatic nerve blocks for complex outpatient knee surgery are associated with less postoperative pain before same-day discharge: a review of 1,200 consecutive cases from the period 1996-1999. Anesthesiology. 2003 May;98(5):1206-13. doi: 10.1097/00000542-200305000-00024.
- Background: PubMed 15108988Williams BA, Kentor ML, Vogt MT, Vogt WB, Coley KC, Williams JP, Roberts MS, Chelly JE, Harner CD, Fu FH. Economics of nerve block pain management after anterior cruciate ligament reconstruction: potential hospital cost savings via associated postanesthesia care unit bypass and same-day discharge. Anesthesiology. 2004 Mar;100(3):697-706. doi: 10.1097/00000542-200403000-00034.
- Results publication: PubMed 16436852Williams BA, Kentor ML, Vogt MT, Irrgang JJ, Bottegal MT, West RV, Harner CD, Fu FH, Williams JP. Reduction of verbal pain scores after anterior cruciate ligament reconstruction with 2-day continuous femoral nerve block: a randomized clinical trial. Anesthesiology. 2006 Feb;104(2):315-27. doi: 10.1097/00000542-200602000-00018.
- Results publication: PubMed 17543813Williams BA, Kentor ML, Irrgang JJ, Bottegal MT, Williams JP. Nausea, vomiting, sleep, and restfulness upon discharge home after outpatient anterior cruciate ligament reconstruction with regional anesthesia and multimodal analgesia/antiemesis. Reg Anesth Pain Med. 2007 May-Jun;32(3):193-202. doi: 10.1016/j.rapm.2006.12.002.
- Results publication: PubMed 17543812Williams BA, Bottegal MT, Kentor ML, Irrgang JJ, Williams JP. Rebound pain scores as a function of femoral nerve block duration after anterior cruciate ligament reconstruction: retrospective analysis of a prospective, randomized clinical trial. Reg Anesth Pain Med. 2007 May-Jun;32(3):186-92. doi: 10.1016/j.rapm.2006.10.011.
- Results publication: PubMed 18042869Bost JE, Williams BA, Bottegal MT, Dang Q, Rubio DM. The 8-item Short-Form Health Survey and the physical comfort composite score of the quality of recovery 40-item scale provide the most responsive assessments of pain, physical function, and mental function during the first 4 days after ambulatory knee surgery with regional anesthesia. Anesth Analg. 2007 Dec;105(6):1693-700, table of contents. doi: 10.1213/01.ane.0000287659.14893.65.
- Results publication: PubMed 17377133Williams BA, Kentor ML, Bottegal MT. The incidence of falls at home in patients with perineural femoral catheters: a retrospective summary of a randomized clinical trial. Anesth Analg. 2007 Apr;104(4):1002. doi: 10.1213/01.ane.0000256006.46703.7f. No abstract available.
- Results publication: PubMed 17456710Williams BA, Bolland MA, Orebaugh SL, Bottegal MT, Kentor ML. Skin reactions at the femoral perineural catheter insertion site: retrospective summary of a randomized clinical trial. Anesth Analg. 2007 May;104(5):1309-10. doi: 10.1213/01.ane.0000260353.11142.d4. No abstract available.
- Results publication: PubMed 18073577Williams BA, Bottegal MT, Francis KA, Irrgang JJ, Vogt MT. A post hoc analysis of research study staffing: budgetary effects of the Health Insurance Portability and Accountability Act on research staff work hours during a prospective, randomized clinical trial. Anesthesiology. 2007 Nov;107(5):860-1. doi: 10.1097/01.anes.0000287212.90397.6b. No abstract available.
Related trials for Anterior Cruciate Ligament Rupture
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
RecruitingObservational study
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
ACL Tears
RecruitingPhase 2
Preventing Injured Knees From osteoArthritis: Severity Outcomes
Osteoarthritis, Knee, Post-traumatic Osteoarthritis
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.
Brian A. Williams, MD, MBA principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Single-injection femoral nerve block and Femoral nerve block 60-hour continuous injection in people with Anterior Cruciate Ligament Rupture, run by University of Pittsburgh 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 9 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 3 May 2013. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain scores during the first week after surgery (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00022854, which also lists 11 linked publications.
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 3 May 2013.