Anesthesia, RegionalNCT03449680
The Analgesic Efficacy of the Ultrasound-Guided Femoral Articular Branch Block for Ambulatory Hip Arthroscopy
A study testing Femoral Articular Branch Block in people with Anesthesia, Regional, run by Women's College Hospital at 1 site in Canada.
Trial summary
Hip arthroscopy surgery can be associated with significant pain. A regional anesthesia technique, the femoral articular branch block (FAB), has recently been proposed to collectively block terminal femoral and accessory obturator nerve branches to the hip joint with a single injection, theoretically blocking most of… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anesthesia, Regional
- What is being tested?
- Femoral Articular Branch Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteCanada
- Study dates
- 4 Mar 2018to 1 Mar 2025
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical classification system, ASA I-III patients
- 18 - 60 years of age
- Body Mass Index (BMI) <35 kg/m2
Who cannot join
- Pre-existing neurological deficits or peripheral neuropathy in the distribution of femoral, obturator, or lateral cutaneous nerves
- Local infection
- Contra-indication to regional anesthesia e.g. bleeding diathesis, coagulopathy
- Chronic pain disorders
- History of using over 30mg of oxycodone or equivalent per day
- Contraindication to a component of multi-modal analgesia
Show all 12Show fewer
- Allergy to local anesthesia
- History of significant psychiatric conditions that may affect patient assessment
- Pregnancy
- Inability to provide informed consent
- Patient refusal of femoral articular branch block
- Revision arthroscopy surgeries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Analgesic Efficacy of the Ultrasound-Guided Femoral Articular Branch Block for Ambulatory Hip Arthroscopy: A Randomized-Controlled Trial
Hip arthroscopy surgery can be associated with significant pain. A regional anesthesia technique, the femoral articular branch block (FAB), has recently been proposed to collectively block terminal femoral and accessory obturator nerve branches to the hip joint with a single injection, theoretically blocking most of the innervation relevant to hip arthroscopy while sparing the main femoral nerve branches to the quadriceps muscles. The investigators aim to demonstrate the analgesic benefits of FAB. The investigators hypothesize that FAB will reduce opioid consumption and improve postoperative quality of recovery in patients having hip arthroscopy. This is a randomized, controlled, double-blind study and half the patients will be randomized to receive the femoral articular branch block and the other half of patients will be randomized to receive a placebo block. A comparison of pain will be made between both groups.
Read the detailed description
Hip arthroscopy is a surgical technique that is gaining popularity for its diagnostic and therapeutic role in the management of adult hip pain. This procedure is frequently associated with severe post-operative pain despite the practice of injecting the hip joint with local anesthetics at the end of the procedure and the use of intraoperative opioids. The ideal analgesic technique that provides adequate pain relief following this procedure has not been established yet.
There is evidence to suggest that a femoral nerve block (FNB) may provide clinically meaningful analgesia. The investigators have examined the benefits of FNB both retrospectively and prospectively in hip arthroscopy patients at Women's College Hospital (WCH). Both of our studies suggested modest benefits of the FNB in terms of controlling post-operative pain and reducing opioid consumption. However the majority of patients continued to experience moderate to severe post-operative pain and required significant amounts of opioid analgesics in the Peri-Anesthesia Unit (PAU), despite receiving the FNB.
Another regional anesthesia technique, the femoral articular branch block (FAB) has recently been proposed to collectively block the terminal femoral and accessory obturator nerve branches to the hip joint with a single injection, theoretically blocking most of the innervation relevant to hip arthroscopy while sparing the main femoral nerve branches to the quadriceps muscle. The investigators aim to demonstrate the analgesic benefits of FAB.
- Conditions
- Anesthesia, Regional
- Being tested
- Femoral Articular Branch Block, Placebo Block
- Keywords
- hip arthroscopy, femoral articular branch block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral Articular Branch BlockProcedure or surgery
Slow injection (3mL aliquots) of local anesthetic solution (20ml of Ropivacaine 0.5%) into the fascia above the iliopsoas muscle (located in the groove between the two bony landmarks - (1)anterior inferior iliac crest and (2)iliopubic eminence).This is done by ultrasound guidance.
Placebo BlockProcedure or surgery
Subcutaneous injection of 1ml normal sterile saline
| Study group | Role | What they receive |
|---|---|---|
| Femoral Articular Branch Block | Experimental | Patients will receive an ultrasound-guided femoral articular branch block with an injection of 20ml of ropivicaine 0.5% Receives: Procedure: Femoral Articular Branch Block |
| Placebo Block | Placebo comparator | Patients will receive an ultrasound simulation of the location of a femoral articular branch block , this is to maintain blinding. A subcutaneous injection of 1ml of normal sterile saline will be administered Receives: Procedure: Placebo Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic Consumption
Postoperative cumulative oral morphine equivalent consumption during the first 24 hours will be the first primary outcome
Measured: 24 hours postoperatively
Quality of Life scores
Quality of Recovery (QR15) scores at 24 hours will be the second primary outcome.
QR15 is a measurement of quality of recovery after surgery and anesthesia that has been psychometrically tested and validated. Reporting of outcome measures on a scale of 0 to 10 (0=None of the time and 10=All of the time). There are a total of 40 items/questions.
Measured: 24 hours postoperatively
Secondary outcomes (7)
Pain Assessment (VAS)
Visual Analogue Scale(VAS) - Pain:Overall pain assessed at rest and on movement A continuous scale comprised of a 100mm (10cm) horizontal line, anchored by 2 verbal descriptions No Pain to Worst Pain
Measured: Up to 48 hours post-operatively and at 7-day mark
Analgesic Consumption
Consumption intra-operatively, total in-hospital postoperative consumption, and time to first analgesic request in the first 24 hours, cumulative oral morphine equivalent
Measured: Up to 48 hours following surgery
Presence of Block-related complications
vascular puncture, hematoma formation, intravascular injection, epidural anesthesia-bilateral sensory block Presence/ absence of residual paresthesia or numbness over femoral, obturator, and lateral cutaneous nerves distribution
Measured: Up until one month following nerve block
Incidence of opioid-related side effects
nausea, vomiting, pruritus, sedation
Measured: Up until one month following nerve block
Patient Satisfaction with Analgesic Technique
A Patient Diary will be completed to assess overall satisfaction with analgesic technique
Measured: One month after surgery
Demographic Data
Patient demographics - There is no scale, just questions asked of the participant.
Measured: Day 1 - first 24 hours
Turn over time
PAU leaving time
Measured: after surgery up to discharge, assessed up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start4 Mar 2018
- Primary completion31 Jan 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, RegionalStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized between one of two treatment groups. The intervention of femoral articular branch block or the control group (non-invasive placebo).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Brull, MD, Principal investigator, Women's College Hospital, University of TorontoDaniel Whelan, MD, Principal investigator, Women's College Hospital, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03449680
- Sponsor's protocol ID
- 2016-0119-B
- Status last verified
- Mar 2025
- First submitted
- 1 Sep 2017
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Short AJ, Barnett JJG, Gofeld M, Baig E, Lam K, Agur AMR, Peng PWH. Anatomic Study of Innervation of the Anterior Hip Capsule: Implication for Image-Guided Intervention. Reg Anesth Pain Med. 2018 Feb;43(2):186-192. doi: 10.1097/AAP.0000000000000701.
PubMed 29140962Suzuki S, Awaya G, Okada Y, Maekawa M, Ikeda T, Tada H. Arthroscopic diagnosis of ruptured acetabular labrum. Acta Orthop Scand. 1986 Dec;57(6):513-5. doi: 10.3109/17453678609014781.
PubMed 3577718Larson CM, Swaringen J, Morrison G. A review of hip arthroscopy and its role in the management of adult hip pain. Iowa Orthop J. 2005;25:172-9.
PubMed 16089093Baber YF, Robinson AH, Villar RN. Is diagnostic arthroscopy of the hip worthwhile? A prospective review of 328 adults investigated for hip pain. J Bone Joint Surg Br. 1999 Jul;81(4):600-3. doi: 10.1302/0301-620x.81b4.8803.
PubMed 10463728Lee EM, Murphy KP, Ben-David B. Postoperative analgesia for hip arthroscopy: combined L1 and L2 paravertebral blocks. J Clin Anesth. 2008 Sep;20(6):462-5. doi: 10.1016/j.jclinane.2008.04.012.
PubMed 18929290Baker JF, Byrne DP, Hunter K, Mulhall KJ. Post-operative opiate requirements after hip arthroscopy. Knee Surg Sports Traumatol Arthrosc. 2011 Aug;19(8):1399-402. doi: 10.1007/s00167-010-1248-4. Epub 2010 Sep 9.
PubMed 20827460Ward JP, Albert DB, Altman R, Goldstein RY, Cuff G, Youm T. Are femoral nerve blocks effective for early postoperative pain management after hip arthroscopy? Arthroscopy. 2012 Aug;28(8):1064-9. doi: 10.1016/j.arthro.2012.01.003. Epub 2012 Apr 11.
PubMed 22498045Dold AP, Murnaghan L, Xing J, Abdallah FW, Brull R, Whelan DB. Preoperative femoral nerve block in hip arthroscopic surgery: a retrospective review of 108 consecutive cases. Am J Sports Med. 2014 Jan;42(1):144-9. doi: 10.1177/0363546513510392. Epub 2013 Nov 27.
PubMed 24284048Xing JG, Abdallah FW, Brull R, Oldfield S, Dold A, Murnaghan ML, Whelan DB. Preoperative Femoral Nerve Block for Hip Arthroscopy: A Randomized, Triple-Masked Controlled Trial. Am J Sports Med. 2015 Nov;43(11):2680-7. doi: 10.1177/0363546515602468. Epub 2015 Sep 24.
PubMed 26403206GARDNER E. The innervation of the hip joint. Anat Rec. 1948 Jul;101(3):353-71. doi: 10.1002/ar.1091010309. No abstract available.
PubMed 18873153Dee R. Structure and function of hip joint innervation. Ann R Coll Surg Engl. 1969 Dec;45(6):357-74. No abstract available.
PubMed 5359432Birnbaum K, Prescher A, Hessler S, Heller KD. The sensory innervation of the hip joint--an anatomical study. Surg Radiol Anat. 1997;19(6):371-5. doi: 10.1007/BF01628504.
PubMed 9479711Tan JMH, Giron-Arango L, Campbell S, Diaz-Martinez JP, Abdallah F, Brull R. Analgesic efficacy of the ultrasound-guided pericapsular nerve group (PENG) block for ambulatory hip arthroscopy: a randomized controlled double-blind trial. Reg Anesth Pain Med. 2026 Mar 27:rapm-2026-107706. doi: 10.1136/rapm-2026-107706. Online ahead of print.
PubMed 41895809
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Efficacy of the Ultrasound-Guided Femoral Articular Branch Block for Ambulatory Hip Arthroscopy: A Randomized-Controlled Trial
- ClinicalTrials.gov ID
- NCT03449680
- Acronym / sponsor ID
- 2016-0119-B
- Conditions
- Anesthesia, Regional
- Keywords
- hip arthroscopy, femoral articular branch block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Study start
- 4 Mar 2018 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 28 Feb 2018 (actual)
- 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.
Hip arthroscopy surgery can be associated with significant pain. A regional anesthesia technique, the femoral articular branch block (FAB), has recently been proposed to collectively block terminal femoral and accessory obturator nerve branches to the hip joint with a single injection, theoretically blocking most of the innervation relevant to hip arthroscopy while sparing the main femoral nerve branches to the quadriceps muscles. The investigators aim to demonstrate the analgesic benefits of FAB. The investigators hypothesize that FAB will reduce opioid consumption and improve postoperative quality of recovery in patients having hip arthroscopy. This is a randomized, controlled, double-blind study and half the patients will be randomized to receive the femoral articular branch block and the other half of patients will be randomized to receive a placebo block. A comparison of pain will be made between both groups.
Detailed description
Hip arthroscopy is a surgical technique that is gaining popularity for its diagnostic and therapeutic role in the management of adult hip pain. This procedure is frequently associated with severe post-operative pain despite the practice of injecting the hip joint with local anesthetics at the end of the procedure and the use of intraoperative opioids. The ideal analgesic technique that provides adequate pain relief following this procedure has not been established yet.
There is evidence to suggest that a femoral nerve block (FNB) may provide clinically meaningful analgesia. The investigators have examined the benefits of FNB both retrospectively and prospectively in hip arthroscopy patients at Women's College Hospital (WCH). Both of our studies suggested modest benefits of the FNB in terms of controlling post-operative pain and reducing opioid consumption. However the majority of patients continued to experience moderate to severe post-operative pain and required significant amounts of opioid analgesics in the Peri-Anesthesia Unit (PAU), despite receiving the FNB.
Another regional anesthesia technique, the femoral articular branch block (FAB) has recently been proposed to collectively block the terminal femoral and accessory obturator nerve branches to the hip joint with a single injection, theoretically blocking most of the innervation relevant to hip arthroscopy while sparing the main femoral nerve branches to the quadriceps muscle. The investigators aim to demonstrate the analgesic benefits of FAB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized between one of two treatment groups. The intervention of femoral articular branch block or the control group (non-invasive placebo).
| Arm | Type | Receives |
|---|---|---|
| Femoral Articular Branch Block | Experimental | Procedure: Femoral Articular Branch BlockPatients will receive an ultrasound-guided femoral articular branch block with an injection of 20ml of ropivicaine 0.5% |
| Placebo Block | Placebo comparator | Procedure: Placebo BlockPatients will receive an ultrasound simulation of the location of a femoral articular branch block , this is to maintain blinding. A subcutaneous injection of 1ml of normal sterile saline will be administered |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) physical classification system, ASA I-III patients
- 18 - 60 years of age
- Body Mass Index (BMI) <35 kg/m2
Key exclusion criteria (12 listed)
- Pre-existing neurological deficits or peripheral neuropathy in the distribution of femoral, obturator, or lateral cutaneous nerves
- Local infection
- Contra-indication to regional anesthesia e.g. bleeding diathesis, coagulopathy
- Chronic pain disorders
- History of using over 30mg of oxycodone or equivalent per day
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 |
|---|---|---|
| Femoral Articular Branch BlockSlow injection (3mL aliquots) of local anesthetic solution (20ml of Ropivacaine 0.5%) into the fascia above the iliopsoas muscle (located in the groove between the two bony landmarks - (1)anterior inferior iliac crest and (2)iliopubic eminence).This is done by ultrasound guidance. | Procedure or surgery | Femoral Articular Branch Block |
| Placebo BlockSubcutaneous injection of 1ml normal sterile saline | Procedure or surgery | Placebo Block |
Primary outcome
Analgesic Consumption
Time frame: 24 hours postoperatively
Postoperative cumulative oral morphine equivalent consumption during the first 24 hours will be the first primary outcome
Quality of Life scores
Time frame: 24 hours postoperatively
Quality of Recovery (QR15) scores at 24 hours will be the second primary outcome. QR15 is a measurement of quality of recovery after surgery and anesthesia that has been psychometrically tested and validated. Reporting of outcome measures on a scale of 0 to 10 (0=None of the time and 10=All of the time). There are a total of 40 items/questions.
7 secondary outcomes
Pain Assessment (VAS)
Time frame: Up to 48 hours post-operatively and at 7-day mark
Analgesic Consumption
Time frame: Up to 48 hours following surgery
Presence of Block-related complications
Time frame: Up until one month following nerve block
Incidence of opioid-related side effects
Time frame: Up until one month following nerve block
Patient Satisfaction with Analgesic Technique
Time frame: One month after surgery
Demographic Data
Time frame: Day 1 - first 24 hours
Turn over time
Time frame: after surgery up to discharge, assessed up to 24 hours
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 1 Apr 2025.
- Background: PubMed 29140962Short AJ, Barnett JJG, Gofeld M, Baig E, Lam K, Agur AMR, Peng PWH. Anatomic Study of Innervation of the Anterior Hip Capsule: Implication for Image-Guided Intervention. Reg Anesth Pain Med. 2018 Feb;43(2):186-192. doi: 10.1097/AAP.0000000000000701.
- Results publication: PubMed 3577718Suzuki S, Awaya G, Okada Y, Maekawa M, Ikeda T, Tada H. Arthroscopic diagnosis of ruptured acetabular labrum. Acta Orthop Scand. 1986 Dec;57(6):513-5. doi: 10.3109/17453678609014781.
- Results publication: PubMed 16089093Larson CM, Swaringen J, Morrison G. A review of hip arthroscopy and its role in the management of adult hip pain. Iowa Orthop J. 2005;25:172-9.
- Results publication: PubMed 10463728Baber YF, Robinson AH, Villar RN. Is diagnostic arthroscopy of the hip worthwhile? A prospective review of 328 adults investigated for hip pain. J Bone Joint Surg Br. 1999 Jul;81(4):600-3. doi: 10.1302/0301-620x.81b4.8803.
- Results publication: PubMed 18929290Lee EM, Murphy KP, Ben-David B. Postoperative analgesia for hip arthroscopy: combined L1 and L2 paravertebral blocks. J Clin Anesth. 2008 Sep;20(6):462-5. doi: 10.1016/j.jclinane.2008.04.012.
- Results publication: PubMed 20827460Baker JF, Byrne DP, Hunter K, Mulhall KJ. Post-operative opiate requirements after hip arthroscopy. Knee Surg Sports Traumatol Arthrosc. 2011 Aug;19(8):1399-402. doi: 10.1007/s00167-010-1248-4. Epub 2010 Sep 9.
- Results publication: PubMed 22498045Ward JP, Albert DB, Altman R, Goldstein RY, Cuff G, Youm T. Are femoral nerve blocks effective for early postoperative pain management after hip arthroscopy? Arthroscopy. 2012 Aug;28(8):1064-9. doi: 10.1016/j.arthro.2012.01.003. Epub 2012 Apr 11.
- Results publication: PubMed 24284048Dold AP, Murnaghan L, Xing J, Abdallah FW, Brull R, Whelan DB. Preoperative femoral nerve block in hip arthroscopic surgery: a retrospective review of 108 consecutive cases. Am J Sports Med. 2014 Jan;42(1):144-9. doi: 10.1177/0363546513510392. Epub 2013 Nov 27.
- Results publication: PubMed 26403206Xing JG, Abdallah FW, Brull R, Oldfield S, Dold A, Murnaghan ML, Whelan DB. Preoperative Femoral Nerve Block for Hip Arthroscopy: A Randomized, Triple-Masked Controlled Trial. Am J Sports Med. 2015 Nov;43(11):2680-7. doi: 10.1177/0363546515602468. Epub 2015 Sep 24.
- Results publication: PubMed 18873153GARDNER E. The innervation of the hip joint. Anat Rec. 1948 Jul;101(3):353-71. doi: 10.1002/ar.1091010309. No abstract available.
- Results publication: PubMed 5359432Dee R. Structure and function of hip joint innervation. Ann R Coll Surg Engl. 1969 Dec;45(6):357-74. No abstract available.
- Results publication: PubMed 9479711Birnbaum K, Prescher A, Hessler S, Heller KD. The sensory innervation of the hip joint--an anatomical study. Surg Radiol Anat. 1997;19(6):371-5. doi: 10.1007/BF01628504.
- Individual participant dataSharing planned: No
Related trials for Anesthesia, Regional
RecruitingPhase 3
A Study of Changes to Prostate Procedures
Prostate Cancer
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
Not yet recruiting
Use of a Virtual Reality Headset During Prostate Biopsy Under Local Anesthesia to Improve the Patient's Experience
Prostate Biopsy
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
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.
Richard Brull, MD principal investigator
Women's College Hospital, University of Toronto
Daniel Whelan, MD principal investigator
Women's College Hospital, University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femoral Articular Branch Block in people with Anesthesia, Regional, run by Women's College Hospital at 1 site in Canada.
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 3 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 1 Apr 2025. 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 Canada. 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.
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?
Analgesic Consumption (time frame: 24 hours postoperatively). The study lists 2 primary outcomes in all. 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 NCT03449680, which also lists 13 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 1 Apr 2025.