Hip Arthroscopy Pain Control Randomized Control Trial (RCT)

NCT02947178 | Completed Phase 4

• 1 other identifier: 500025
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

Femoroacetabular impingement is a pathologic process within the hip joint that results from a mechanical discord between the femoral head and neck and the acetabulum that results in chronic hip pain, hip labral tears and early progression of osteoarthritis of the hip.1, 2 Historically an open surgical hip dislocation was performed to treat patients with this condition, however with recent advances in arthroscopy, patients more commonly now undergo arthroscopic hip surgery. From a pain management standpoint, previous attempts to provide peri-operative analgesia included intraarticular or portal analgesic injections. More recently, regional anesthesia techniques are being employed to provide more reliable and longer lasting post-operative pain control.3, 4 Currently, there are several local anesthetics available for regional anesthesia. However, they only provide an average of 12-18 hours of post-operative pain control following a single injection.5 Bupivacaine is a local anesthetic that has been used for many years by multiple routes to control post-operative pain. A new formulation of the medication prolongs the release of the active ingredient after a single injection and has been shown to result in up to 72 hours of post-operative analgesia.6, 7 To the investigator's knowledge, there has not been any studies in the literature comparing a historical control local anesthetic to this new formulation of liposomal bupivacaine via a fascial iliaca regional soft tissue infiltration blockade to provide post operative pain control following hip arthroscopy.

Conditions

Hip Pain Chronic; Anesthesia; Bupivacaine

Outcome Measures

Primary Outcomes (1)

• Pain

  To compare post-operative pain scores between the two treatments groups. To advance this objective, DVPRS (Defense and Veterans Pain Rating Scale) scores will be collected and analyzed at discharge and on post-operative days one, two, and three. The investigator's hypothesize that the addition of liposomal bupivacaine will result in a 2-point improvement in DVPRS scores during the post-operative period.

  Immediate Post-operative

Secondary Outcomes (1)

• Opioid Use

  Immediate Post-operative

Study Arms (2)

Bupivicaine

ACTIVE COMPARATOR

Bupivicaine fascial iliaca regional soft tissue infiltration blockade

Procedure: Fascial iliac regional soft tissue infiltration blockade; Behavioral: Pain Score Survey; Behavioral: Pill Count; Drug: Bupivacaine

Bupivacaine plus liposomal bupivacaine

ACTIVE COMPARATOR

Bupivacaine plus liposomal bupivacaine fascial iliaca regional soft tissue infiltration blockade

Procedure: Fascial iliac regional soft tissue infiltration blockade; Behavioral: Pain Score Survey; Behavioral: Pill Count; Drug: Bupivacaine; Drug: Liposomal Bupivacaine

Interventions

Fascial iliac regional soft tissue infiltration blockade PROCEDURE

Fascial iliac regional soft tissue infiltration blockade: Pain relief procedure (offered to all patients undergoing hip arthroscopy)

Bupivacaine plus liposomal bupivacaine; Bupivicaine

Pain Score Survey BEHAVIORAL

Utilizing: Defense and Veterans Pain Rating Scale (DVPRS)

Bupivacaine plus liposomal bupivacaine; Bupivicaine

Pill Count BEHAVIORAL

Patient reported as needed (prn) pain medication usage

Bupivacaine plus liposomal bupivacaine; Bupivicaine

Bupivacaine DRUG

Bupivacaine plus liposomal bupivacaine; Bupivicaine

Liposomal Bupivacaine DRUG

Bupivacaine plus liposomal bupivacaine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patient is scheduled to undergo hip arthroscopy
• Patient is between 18-50 years of age
• DEERS eligibility

You may not qualify if:

• Patients who are on a medication pre-operatively that would prohibit them from receiving one of the study medications
• Patient is unable to speak/read the English language (Currently, the DVPRS has only been scientifically validated in the English language and translating to languages other than English would compromise the validity of the pain scale)
• Patient has a history of previous hip arthroscopy surgery
• The patient is pregnant - ruled out with routine urine pregnancy test the morning of surgery in the anesthesia pre-operative unit.
• The patient carries a pre-existing diagnosis of a pain disorder. (Example: Fibromyalgia)
• The patient has a previous history of narcotic pain medication abuse.
• The patient has an allergy to one of the study medications

Sponsors & Collaborators

• Walter Reed National Military Medical Center: lead

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Michael Kent, MD

  Walter Reed National Military Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2016
• First Posted: October 27, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: January 10, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)