Intra-articular Morphine and Clonidine Injections for Pain Management in Hip Arthroscopy

NCT02530151 | Completed Phase 4 Results

• 1 other identifier: STU00201218
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether intraoperative (during surgery) morphine and clonidine hip injections are effective in postoperative pain management for patients undergoing hip arthroscopy.

Conditions

Femoracetabular Impingement; Pain, Postoperative

Keywords

Hip arthroscopy; Intra-articular injection; Morphine; Clonidine

Outcome Measures

Primary Outcomes (1)

• Opioid Consumption in the Acute Postoperative Period

  The total usage of opioid medication (mEq) for pain relief in the intraoperative period and again through the postoperative recovery period from arrival in the PACU through 7 days post op

  Recorded intraoperatively, during PACU stay, 6 hours post discharge, 18 hours post discharge, 24 hours post discharge, 48 hours post discharge, and at 7 days post discharge

Secondary Outcomes (2)

• Visual Analog Scale (VAS) Pain Scores

  Immediately preoperative (5-10 minutes before surgery), immediately postoperative (5-10 minutes after surgery), 1 hr post operatively

• Quality of Recovery (QoR-15) Scores for Patient Reported Recovery Following Surgery

  Preoperative to 24 hrs. post operatively

Study Arms (2)

Morphine with Clonidine

EXPERIMENTAL

11 mL intra-articular injection of 10 mg morphine and 100 mcg clonidine in .9% NaCl solution at conclusion of hip arthroscopy procedure

Drug: Morphine with clonidine

Normal Saline

PLACEBO COMPARATOR

11 mL intra-articular injection of .9% NaCl solution at conclusion of hip arthroscopy procedure

Other: Normal saline

Interventions

Morphine with clonidine DRUG

see arm description

Morphine with Clonidine

Normal saline OTHER

see arm description

Normal Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient undergoing a hip arthroscopy procedure for femoracetabular impingement by the senior surgeon (M.T.)

You may not qualify if:

• Morphine contraindication
• Clonidine contraindication
• Pregnant women
• Prisoners
• Adults unable to consent

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Joshua Barett

Chicago, Illinois, 60611, United States

Location

Related Publications (7)

• Lynch TS, Terry MA, Bedi A, Kelly BT. Hip arthroscopic surgery: patient evaluation, current indications, and outcomes. Am J Sports Med. 2013 May;41(5):1174-89. doi: 10.1177/0363546513476281. Epub 2013 Feb 28.

  PMID: 23449836 BACKGROUND

• Ramsay MA. Acute postoperative pain management. Proc (Bayl Univ Med Cent). 2000 Jul;13(3):244-7. doi: 10.1080/08998280.2000.11927683. No abstract available.

  PMID: 16389390 BACKGROUND

• Stein C, Comisel K, Haimerl E, Yassouridis A, Lehrberger K, Herz A, Peter K. Analgesic effect of intraarticular morphine after arthroscopic knee surgery. N Engl J Med. 1991 Oct 17;325(16):1123-6. doi: 10.1056/NEJM199110173251602.

  PMID: 1653901 BACKGROUND

• Yari M, Saeb M, Golfam P, Makhloogh Z. Analgesic efficacy of intra-articular morphine after arthroscopic knee surgery in sport injury patients. J Inj Violence Res. 2013 Jul;5(2):84-8. doi: 10.5249/jivr.v5i2.303. Epub 2013 Jul 1.

  PMID: 23281420 BACKGROUND

• Zeng C, Gao SG, Cheng L, Luo W, Li YS, Tu M, Tian J, Xu M, Zhang FJ, Jiang W, Wei LC, Lei GH. Single-dose intra-articular morphine after arthroscopic knee surgery: a meta-analysis of randomized placebo-controlled studies. Arthroscopy. 2013 Aug;29(8):1450-8.e2. doi: 10.1016/j.arthro.2013.04.005. Epub 2013 Jun 12.

  PMID: 23768848 BACKGROUND

• Joshi W, Reuben SS, Kilaru PR, Sklar J, Maciolek H. Postoperative analgesia for outpatient arthroscopic knee surgery with intraarticular clonidine and/or morphine. Anesth Analg. 2000 May;90(5):1102-6. doi: 10.1097/00000539-200005000-00018.

  PMID: 10781460 BACKGROUND

• Lavelle W, Lavelle ED, Lavelle L. Intra-articular injections. Anesthesiol Clin. 2007 Dec;25(4):853-62, viii. doi: 10.1016/j.anclin.2007.07.002.

  PMID: 18054149 BACKGROUND

MeSH Terms

Conditions

Femoracetabular Impingement; Pain, Postoperative

Interventions

Morphine; Clonidine; Saline Solution

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Michael Terry, MD
• Organization: Northwestern University

mterry@nm.org

312-472-6488

Study Officials

• Michael Terry, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Orthopaedic Surgery

Study Record Dates

• First Submitted: August 18, 2015
• First Posted: August 20, 2015
• Study Start: November 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: September 23, 2019
• Results First Posted: May 20, 2019

Record last verified: 2019-09

Locations

US (1)