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Clinical Trials/NCT02530151
NCT02530151CompletedPhase 4

Prospective Assessment of Intraoperative Intra-articular Morphine and Clonidine Injection in Hip Arthroscopy on Postoperative Pain Management

Northwestern University1 site in 1 country70 target enrollmentStarted: November 2015Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
70
Locations
1
Primary Endpoint
Opioid Consumption in the Acute Postoperative Period

Study Overview

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.

Detailed Description

Background:

Over the last few decades, the use and safety of arthroscopic hip surgery has considerably improved though the evolution and development of arthroscopic imaging and instrumentation (Lynch et al., 2013). There is still a considerable amount of room for growth and research in comparison to arthroscopic knee and shoulder surgery, which have been around much longer. One area which needs attention is postoperative pain management for patients undergoing hip arthroscopy. The benefits to controlling postoperative pain range from improved patient comfort and decreased time of recovery to decreased narcotic medication usage and reduced cost of care (Ramsay 2000).

Many studies on the use of morphine injections into the joint after arthroscopic knee surgery have demonstrated effectiveness in reducing both patient reported pain and narcotic medication usage after surgery (Stein et al., 1991; Yari et al., 2013; Zeng et al., 2014). Furthermore, studies have shown that joint injections of clonidine improve the pain relieving effect of morphine when the two are used in combination (Joshi et al., 2000). While there is considerable evidence supporting the use of joint injections of morphine for knee surgery, very little has been cited for such use in hip arthroscopy (Lavelle et al., 2007). The purpose of our study is to better assess the effectiveness of morphine and clonidine joint injections in reducing patient reported pain and narcotic medication usage after hip arthroscopy.

Protocol:

Participants in this study will be part of a trial for the use of a morphine and clonidine joint injection during hip surgery. Participants will be randomly selected to either receive a standard dose of morphine and clonidine or normal saline solution through a joint injection. The normal saline will have no active drug ingredients. In either case the injection will occur at the conclusion of surgery. The joint injection is the only change to the medical care that will occur for patients who decide to participate in this study. Pain levels will be monitored and treated after surgery, and all pain management after surgery will follow the normal standard of care. Additionally, participants will be asked to fill out a brief questionnaire before and after surgery. All patients will be sent home with a short diary that will allow them to record their medication usage, pain scores, and potential side effects in the week following surgery. The diary with this information will be returned when the patients come back for their standard-of-care two week follow-up appointment.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

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

Intervention: Morphine with clonidine (Drug)

Normal Saline

Placebo Comparator

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

Intervention: Normal saline (Other)

Outcomes

Primary Outcomes

Opioid Consumption in the Acute Postoperative Period

Time Frame: 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

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

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Michael Terry

Associate Professor in Orthopaedic Surgery

Northwestern University

Study Sites (1)

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