Femoracetabular ImpingementPhase 4NCT02530151
Intra-articular Morphine and Clonidine Injections for Pain Management in Hip Arthroscopy
A Phase 4 study testing Morphine with clonidine and Normal saline in people with Femoracetabular Impingement and Pain, Postoperative, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoracetabular Impingement, Pain, Postoperative
- What is being tested?
- Morphine with clonidine and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to May 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient undergoing a hip arthroscopy procedure for femoracetabular impingement by the senior surgeon (M.T.)
Who cannot join
- Morphine contraindication
- Clonidine contraindication
- Pregnant women
- Prisoners
- Adults unable to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Femoracetabular Impingement, Pain, Postoperative
- Being tested
- Morphine with clonidine, Normal saline
- Keywords
- Hip arthroscopy, Intra-articular injection, Morphine, Clonidine
- Medical subject headings
- Femoracetabular Impingement, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphine with clonidineDrug
see arm description
Normal salineOther
see arm description
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Morphine with clonidine |
| Normal Saline | Placebo comparator | 11 mL intra-articular injection of .9% NaCl solution at conclusion of hip arthroscopy procedure Receives: Other: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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
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
Measured: Preoperative to 24 hrs. post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study startNov 2015
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Femoracetabular ImpingementStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Terry, Northwestern University
- Investigators
- Michael Terry, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02530151
- Sponsor's protocol ID
- STU00201218
- Status last verified
- Sep 2019
- First submitted
- 18 Aug 2015
- Last updated
- 23 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 23449836Ramsay 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.
PubMed 16389390Stein 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.
PubMed 1653901Yari 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.
PubMed 23281420Zeng 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.
PubMed 23768848Joshi 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.
PubMed 10781460Lavelle 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.
PubMed 18054149
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Assessment of Intraoperative Intra-articular Morphine and Clonidine Injection in Hip Arthroscopy on Postoperative Pain Management
- ClinicalTrials.gov ID
- NCT02530151
- Acronym / sponsor ID
- STU00201218
- Conditions
- Femoracetabular Impingement, Pain, Postoperative
- Keywords
- Hip arthroscopy, Intra-articular injection, Morphine, Clonidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 20 Aug 2015 (estimated)
- Results
- Posted 20 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morphine with Clonidine | Experimental | Drug: Morphine with clonidine11 mL intra-articular injection of 10 mg morphine and 100 mcg clonidine in .9% NaCl solution at conclusion of hip arthroscopy procedure |
| Normal Saline | Placebo comparator | Other: Normal saline11 mL intra-articular injection of .9% NaCl solution at conclusion of hip arthroscopy procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient undergoing a hip arthroscopy procedure for femoracetabular impingement by the senior surgeon (M.T.)
Key exclusion criteria (5 listed)
- Morphine contraindication
- Clonidine contraindication
- Pregnant women
- Prisoners
- Adults unable to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morphine with clonidinesee arm description | Drug | Morphine with Clonidine |
| Normal salinesee arm description | Other | Normal Saline |
Primary outcome
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
2 secondary outcomes
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
Quality of Recovery (QoR-15) Scores for Patient Reported Recovery Following Surgery
Time frame: Preoperative to 24 hrs. post operatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23449836Lynch 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.
- Background: PubMed 16389390Ramsay 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.
- Background: PubMed 1653901Stein 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.
- Background: PubMed 23281420Yari 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.
- Background: PubMed 23768848Zeng 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.
- Background: PubMed 10781460Joshi 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.
- Background: PubMed 18054149Lavelle 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Terry, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Morphine with clonidine and Normal saline in people with Femoracetabular Impingement and Pain, Postoperative, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02530151, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019.