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Surgery, ArthroscopicNCT04538105

Preoperative Fluoroscopy Guided Hip Articular Branch Blocks and Analgesic Outcomes Following Hip Arthroscopy

A study testing Articular Branch Block (ABB) in people with Surgery, Arthroscopic and Analgesia, run by Rush University Medical Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Arthroscopic hip surgeries are increasingly being performed as both diagnostic and therapeutic interventions. These procedures are considerably painful, thus requiring the proper pain management techniques in order to provide patient satisfaction and sufficient pain control. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Surgery, Arthroscopic, Analgesia, Pain, Acute
What is being tested?
Articular Branch Block (ABB)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
1 May 2021to 1 Oct 2022
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 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Presenting for Hip Arthroscopy (Diagnostic or Therapeutic)
  • Pre-operative Numeric Rating Score (NRS) for pain <8 on a 0 to 10 scale where 0 is no pain and 10 is worst pain imaginable.

Who cannot join

  • Allergies to any of the study medications
  • Anti-coagulation status (INR > 1.1, PT or APTT > 1.5 control)
  • History of Hip Arthroplasty
  • Infection of Hip
  • Evidence of tumor
  • Pregnancy
  • History of diabetes with HbA1c > 10%
  • Prior history of Hip Articular Branch Blockade or Hip Articular Branch PRF Ablation

About this study

Official title: Preoperative Fluoroscopy Guided Hip Articular Branch Blocks and Analgesic Outcomes Following Hip Arthroscopy: A Randomized, Controlled Trial

Arthroscopic hip surgeries are increasingly being performed as both diagnostic and therapeutic interventions. These procedures are considerably painful, thus requiring the proper pain management techniques in order to provide patient satisfaction and sufficient pain control. Articular branch blocks have not been evaluated for their use in hip arthroscopy, but have potential advantages of blocking the sensory innervation of the entire hip joint, with minimal impact on motor innervation compared to alternative blocks.

This current study aims to evaluate the efficacy of using preoperative fluoroscopic-guided blockade of articular branches of the femoral and obturator nerves for analgesic management of patients undergoing arthroscopy compared to a saline sham block.

The utility of pre-operative hip articular branch block (ABB) prior to hip arthroscopy will provide superior pain management postoperatively compared to a saline sham block. We hypothesize that the ABB (Articular Branch Block) will reduce the area under the NRS pain scores by time curve (AUC) and decreased oral opioid milligram equivalent use in the first 24 hours post-operatively.

Being tested
Control, Articular Branch Block (ABB)
Keywords
hip arthroscopy, articular branch block
Medical subject headings
Agnosia, Acute Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ControlOther

    Saline Articular Nerve Branch Block

  • Articular Branch Block (ABB)Other

    0.5% Bupivacaine with epinephrine 1:200,000 (Articular Branch Block)

Study groups in NCT04538105
Study groupRoleWhat they receive
Sham InjectionSham comparator20cc of Normal Saline 0.9%
Receives: Other: Control
Articular Branch Block (ABB)Experimental20cc of 0.5% Bupivacaine with epinephrine 1:200,000
Receives: Other: Articular Branch Block (ABB)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. NRS Pain Scores (NRS)

    Numerical Rating Scale is a self-reported pain assessment, in which a patient indicates their current pain level experienced. Patients can rate their pain on a scale of 0 (no pain) to 10 (worse pain imaginable). Higher scores indicated on this scale may indicate that a patient is experiencing higher pain intensities at that particular point in time. Whereas lower reported scores indicate that the patient is experiencing less intense or minimal pain.

    Measured: 24 hours post-operatively

Secondary outcomes (2)

  1. The QOR-15 (Quality of Recovery)

    Quality of Recovery scores will be obtained 24 hours post-operatively. Scores are reported on an 11 point scale (0 to 10), where 0 = none of the time and 10 = all of the time. Higher scores indicated on the Quality of Recovery scale represent a better recovery outcome.

    Measured: 24 hours post-operatively

  2. Analgesic medication use

    Measured: 24 hours post-operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2020
  2. Study start1 May 2021 (estimated)
  3. Primary completion1 Oct 2021 (estimated)
  4. Study completion1 Oct 2022 (estimated)

Why it stopped: Study cancelled

Resources

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
Masking
Single blind
Who is masked
Participant
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04538105
Sponsor's protocol ID
20051404
Status last verified
Sep 2021
First submitted
17 Aug 2020
Last updated
16 Sep 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Colvin AC, Harrast J, Harner C. Trends in hip arthroscopy. J Bone Joint Surg Am. 2012 Feb 15;94(4):e23. doi: 10.2106/JBJS.J.01886.

    PubMed 22336982

  • Yu HC, Al-Shehri M, Johnston KD, Endersby R, Baghirzada L. Anesthesia for hip arthroscopy: a narrative review. Can J Anaesth. 2016 Nov;63(11):1277-90. doi: 10.1007/s12630-016-0718-7. Epub 2016 Aug 16.

    PubMed 27530361

  • Steinhaus ME, Rosneck J, Ahmad CS, Lynch TS. Outcomes After Peripheral Nerve Block in Hip Arthroscopy. Am J Orthop (Belle Mead NJ). 2018 Jun;47(6). doi: 10.12788/ajo.2018.0049.

    PubMed 29979805

  • GARDNER E. The innervation of the hip joint. Anat Rec. 1948 Jul;101(3):353-71. doi: 10.1002/ar.1091010309. No abstract available.

    PubMed 18873153

  • Aprato A, Giachino M, Masse A. Arthroscopic approach and anatomy of the hip. Muscles Ligaments Tendons J. 2016 Dec 21;6(3):309-316. doi: 10.11138/mltj/2016.6.3.309. eCollection 2016 Jul-Sep.

    PubMed 28066735

  • Byrd JW. Hip arthroscopy. J Am Acad Orthop Surg. 2006 Jul;14(7):433-44. doi: 10.5435/00124635-200607000-00006. No abstract available.

    PubMed 16822891

  • Philippi MT, Kahn TL, Adeyemi TF, Maak TG, Aoki SK. Extracapsular local infiltration analgesia in hip arthroscopy patients: a randomized, prospective study. J Hip Preserv Surg. 2018 Sep 18;5(3):226-232. doi: 10.1093/jhps/hny030. eCollection 2018 Aug.

    PubMed 30393549

  • Kay J, de Sa D, Memon M, Simunovic N, Paul J, Ayeni OR. Examining the Role of Perioperative Nerve Blocks in Hip Arthroscopy: A Systematic Review. Arthroscopy. 2016 Apr;32(4):704-15.e1. doi: 10.1016/j.arthro.2015.12.022. Epub 2016 Feb 20.

    PubMed 26907370

  • Kapural L, Jolly S, Mantoan J, Badhey H, Ptacek T. Cooled Radiofrequency Neurotomy of the Articular Sensory Branches of the Obturator and Femoral Nerves - Combined Approach Using Fluoroscopy and Ultrasound Guidance: Technical Report, and Observational Study on Safety and Efficacy. Pain Physician. 2018 May;21(3):279-284.

    PubMed 29871372

  • Nye ZB, Horn JL, Crittenden W, Abrahams MS, Aziz MF. Ambulatory continuous posterior lumbar plexus blocks following hip arthroscopy: a review of 213 cases. J Clin Anesth. 2013 Jun;25(4):268-74. doi: 10.1016/j.jclinane.2012.11.013. Epub 2013 May 9.

    PubMed 23665305

  • Dold 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 24284048

  • Krych AJ, Baran S, Kuzma SA, Smith HM, Johnson RL, Levy BA. Utility of multimodal analgesia with fascia iliaca blockade for acute pain management following hip arthroscopy. Knee Surg Sports Traumatol Arthrosc. 2014 Apr;22(4):843-7. doi: 10.1007/s00167-013-2665-y. Epub 2013 Sep 24.

    PubMed 24061718

  • Lee 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 18929290

  • Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain. 2004 Sep-Oct;20(5):309-18. doi: 10.1097/00002508-200409000-00005.

    PubMed 15322437

  • Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.

    PubMed 23411725

Questions about this trial

What is this clinical trial studying?

A study testing Articular Branch Block (ABB) in people with Surgery, Arthroscopic and Analgesia, run by Rush University Medical Center.

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 2 inclusion and 8 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: withdrawn, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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?

NRS Pain Scores (NRS) (time frame: 24 hours post-operatively). 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 NCT04538105, which also lists 17 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 16 Sep 2021.

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