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

Phase 4

Completed

• Conditions: Femoracetabular Impingement; Pain, Postoperative
• Interventions: Drug: Morphine with clonidine; Other: Normal saline

• Registration Number: NCT02530151
• Lead Sponsor: Northwestern University

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.

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 Timeline

• Study First Submitted: 2015-08-18
• Study First Submitted QC: 2015-08-19
• Study First Posted: 2015-08-20
• Study Start: 2015-11
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Results First Submitted: 2019-04-19
• Results First Submitted QC: 2019-05-16
• Results First Posted: 2019-05-20
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-19
• Last Update Posted: 2019-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Morphine with Clonidine	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
Normal Saline	Normal saline	11 mL intra-articular injection of .9% NaCl solution at conclusion of hip arthroscopy procedure

Primary Outcome Measures

Name	Time	Method
Opioid Consumption in the Acute Postoperative Period	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 Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS) Pain Scores	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
Quality of Recovery (QoR-15) Scores for Patient Reported Recovery Following Surgery	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

Trial Locations

Locations (1)

Joshua Barett; 🇺🇸 Chicago, Illinois, United States