Intra-articular Morphine and Clonidine Injections for Pain Management in Hip Arthroscopy
Information source: Northwestern University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Femoracetabular Impingement; Pain, Postoperative
Intervention: Morphine with clonidine (Drug); Normal saline (Other)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Northwestern University Official(s) and/or principal investigator(s): Michael Terry, MD, Principal Investigator, Affiliation: Northwestern University
Overall contact: Michael Terry, MD, Phone: 312-695-6800, Ext: 6-4668, Email: mterry@nmff.org
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.
Clinical Details
Official title: Prospective Assessment of Intraoperative Intra-articular Morphine and Clonidine Injection in Hip Arthroscopy on Postoperative Pain Management
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Primary outcome: Opioid consumption
Secondary outcome: Visual Analog Scale pain scores
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.
No additional visits or appointments beyond what the procedure already entails are needed to
participate in this study. The entirety of this study will be completed by the time of
discharge from the surgical center on the date of surgery.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Michael Terry, MD, Phone: 312-695-6800, Ext: 6-4668, Email: mterry@nmff.org Additional Information
Related publications: 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. Ramsay MA. Acute postoperative pain management. Proc (Bayl Univ Med Cent). 2000 Jul;13(3):244-7. 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. 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. 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. Review. 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. Lavelle W, Lavelle ED, Lavelle L. Intra-articular injections. Anesthesiol Clin. 2007 Dec;25(4):853-62, viii. Review.
Starting date: August 2015
Last updated: August 19, 2015
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