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

September 19, 2019 updated by: Michael Terry, Northwestern University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

No additional visits or appointments beyond what the procedure already entails are needed to participate in this study.

The treatment (morphine/clonidine or normal saline injection) will be chosen by chance, like flipping a coin. Neither the participant nor the study doctor will choose which treatment the patient gets. There will be an equal chance of being given either treatment. Neither the participant nor the study doctor will know which treatment is assigned.

Morphine and clonidine are FDA-approved drugs being used in a non-approved context (hip injection). All standard of care procedures will take place to ensure patient safety during and after surgery, while the patients are in the outpatient surgical center. All adverse events will be properly documented and reported to the IRB.

Data Management:

Data points include age, sex, height, weight, tobacco use, VAS pain scores, discharge times, duration of surgery, discharge criteria score, medication use, and scores from the QoR-15 survey. All information that includes personally identifying information, such as name or medical record number, is not entered into the database with the medical information. Identifying information is only entered into a separate database that links the patient to an arbitrary study number.

Statistical analysis of the data will include a Student's T-Test, non-parametric Mann Whitney test, and chi-square test. If there is substantial data missing for a subject, which would be otherwise essential for analysis, the subject's information for that particular analysis will be excluded. To the best extent possible, data that can be interpolated will be utilized.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Joshua Barett

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Morphine with Clonidine
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
see arm description
Placebo Comparator: Normal Saline
11 mL intra-articular injection of .9% NaCl solution at conclusion of hip arthroscopy procedure
Other: Normal saline
see arm description

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS) Pain Scores
Time Frame: Immediately preoperative (5-10 minutes before surgery), immediately postoperative (5-10 minutes after surgery), 1 hr post operatively
Patients will rate their pain (0-10) on the Visual Analog Scale with higher scores for the VAS indicated elevated pain intensity reported by the patient for the indicated time point
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
Time Frame: Preoperative to 24 hrs. post operatively
The Quality of Recovery questionnaire (QoR-15) is a 15 question patient reported outcome measure used to evaluate the quality of recovery following surgical anesthesia concerning pain, physical function, and psychological factors; reported as a summative score with each question graded between 0-10 (Range:0-150) with higher scores indicating improved physical/psychological recovery or infrequent symptoms
Preoperative to 24 hrs. post operatively

Collaborators and Investigators

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

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Michael Terry, MD, Northwestern University

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

November 1, 2015

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

August 18, 2015

First Submitted That Met QC Criteria

August 19, 2015

First Posted (Estimate)

August 20, 2015

Study Record Updates

Last Update Posted (Actual)

September 23, 2019

Last Update Submitted That Met QC Criteria

September 19, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00201218

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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