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

September 13, 2021 updated by: Tolga Suvar, MD, Rush University Medical Center

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham Injection
20cc of Normal Saline 0.9%
Other: Control
Saline Articular Nerve Branch Block
Experimental: Articular Branch Block (ABB)
20cc of 0.5% Bupivacaine with epinephrine 1:200,000
Other: Articular Branch Block (ABB)
0.5% Bupivacaine with epinephrine 1:200,000 (Articular Branch Block)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NRS Pain Scores (NRS)
Time Frame: 24 hours post-operatively
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The QOR-15 (Quality of Recovery)
Time Frame: 24 hours post-operatively
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
Analgesic medication use
Time Frame: 24 hours post-operatively
24 hours post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rush University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2021

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

August 17, 2020

First Submitted That Met QC Criteria

September 2, 2020

First Posted (Actual)

September 3, 2020

Study Record Updates

Last Update Posted (Actual)

September 16, 2021

Last Update Submitted That Met QC Criteria

September 13, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20051404

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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