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

NCT ID: NCT04538105

Last Updated: 2021-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2022-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Surgery, Arthroscopic Analgesia Pain, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Sham Injection

20cc of Normal Saline 0.9%

Group Type SHAM_COMPARATOR

Control

Intervention Type OTHER

Saline Articular Nerve Branch Block

Articular Branch Block (ABB)

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

Group Type EXPERIMENTAL

Articular Branch Block (ABB)

Intervention Type OTHER

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

Interventions

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Control

Saline Articular Nerve Branch Block

Intervention Type OTHER

Articular Branch Block (ABB)

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rush University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Tolga Suvar, MD

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type BACKGROUND
PMID: 22336982 (View on PubMed)

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Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
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Reference Type BACKGROUND
PMID: 18873153 (View on PubMed)

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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
PMID: 26907370 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29871372 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23665305 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24284048 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24061718 (View on PubMed)

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.

Reference Type BACKGROUND
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Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
PMID: 22822195 (View on PubMed)

Other Identifiers

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20051404

Identifier Type: -

Identifier Source: org_study_id

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