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

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04538105
• Other study ID #: 20051404
• Status: Withdrawn
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: October 1, 2022

Study information

• Verified date: September 2021
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Analgesia
• Pain, Acute
• Surgery, Arthroscopic

Intervention

Other:
• Control
Saline Articular Nerve Branch Block
• Articular Branch Block (ABB)
0.5% Bupivacaine with epinephrine 1:200,000 (Articular Branch Block)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

References & Publications (17)

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. — View Citation

Byrd JW. Hip arthroscopy. J Am Acad Orthop Surg. 2006 Jul;14(7):433-44. Review. — View Citation

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. — View Citation

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. — View Citation

GARDNER E. The innervation of the hip joint. Anat Rec. 1948 Jul;101(3):353-71. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Epub 2012 Jul 19. — View Citation

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. Review. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	24 hours post-operatively
Secondary	Analgesic medication use		24 hours post-operatively