NCT04538105

Brief 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. 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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2021

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 3, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

5 months

First QC Date

August 17, 2020

Last Update Submit

September 13, 2021

Conditions

Surgery, ArthroscopicAnalgesiaPain, Acute

Keywords

hip arthroscopyarticular branch block

Outcome Measures

Primary Outcomes (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.

    24 hours post-operatively

Secondary Outcomes (2)

  • The QOR-15 (Quality of Recovery)

    24 hours post-operatively

  • Analgesic medication use

    24 hours post-operatively

Study Arms (2)

Sham Injection

SHAM COMPARATOR

20cc of Normal Saline 0.9%

Other: Control

Articular Branch Block (ABB)

EXPERIMENTAL

20cc of 0.5% Bupivacaine with epinephrine 1:200,000

Other: Articular Branch Block (ABB)

Interventions

ControlOTHER

Saline Articular Nerve Branch Block

Sham Injection
Articular Branch Block (ABB)OTHER

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

Articular Branch Block (ABB)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (17)

  • 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.

    PMID: 22336982BACKGROUND

  • 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.

    PMID: 27530361BACKGROUND

  • 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.

    PMID: 29979805BACKGROUND

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

    PMID: 18873153BACKGROUND

  • 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.

    PMID: 28066735BACKGROUND

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

    PMID: 16822891BACKGROUND

  • 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.

    PMID: 30393549BACKGROUND

  • 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.

    PMID: 26907370BACKGROUND

  • 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.

    PMID: 29871372BACKGROUND

  • 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.

    PMID: 23665305BACKGROUND

  • 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.

    PMID: 24284048BACKGROUND

  • 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.

    PMID: 24061718BACKGROUND

  • 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.

    PMID: 18929290BACKGROUND

  • 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.

    PMID: 15322437BACKGROUND

  • 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.

    PMID: 23411725BACKGROUND

  • Griffin DR, Parsons N, Mohtadi NG, Safran MR; Multicenter Arthroscopy of the Hip Outcomes Research Network. A short version of the International Hip Outcome Tool (iHOT-12) for use in routine clinical practice. Arthroscopy. 2012 May;28(5):611-6; quiz 616-8. doi: 10.1016/j.arthro.2012.02.027.

    PMID: 22542434BACKGROUND

  • YaDeau JT, Tedore T, Goytizolo EA, Kim DH, Green DS, Westrick A, Fan R, Rade MC, Ranawat AS, Coleman SH, Kelly BT. Lumbar plexus blockade reduces pain after hip arthroscopy: a prospective randomized controlled trial. Anesth Analg. 2012 Oct;115(4):968-72. doi: 10.1213/ANE.0b013e318265bacd. Epub 2012 Jul 19.

    PMID: 22822195BACKGROUND

MeSH Terms

Conditions

AgnosiaAcute Pain

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPain
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

August 17, 2020

First Posted

September 3, 2020

Study Start

May 1, 2021

Primary Completion

October 1, 2021

Study Completion

October 1, 2022

Last Updated

September 16, 2021

Record last verified: 2021-09