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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02530151
Enrollment
70
Registered
2015-08-20
Start date
2015-11-30
Completion date
2017-05-31
Last updated
2019-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femoracetabular Impingement, Pain, Postoperative

Keywords

Hip arthroscopy, Intra-articular injection, Morphine, Clonidine

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.

Interventions

DRUGMorphine with clonidine

see arm description

OTHERNormal saline

see arm description

Sponsors

Northwestern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Opioid Consumption in the Acute Postoperative PeriodRecorded 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 dischargeThe 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

MeasureTime frameDescription
Visual Analog Scale (VAS) Pain ScoresImmediately preoperative (5-10 minutes before surgery), immediately postoperative (5-10 minutes after surgery), 1 hr post operativelyPatients 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 SurgeryPreoperative to 24 hrs. post operativelyThe 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

Countries

United States

Participant flow

Participants by arm

ArmCount
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 Morphine with clonidine: see arm description
37
Normal Saline
11 mL intra-articular injection of .9% NaCl solution at conclusion of hip arthroscopy procedure Normal saline: see arm description
33
Total70

Baseline characteristics

CharacteristicMorphine With ClonidineTotalNormal Saline
Age, Continuous40.7 years
STANDARD_DEVIATION 12.9
38.8 years
STANDARD_DEVIATION 12.3
36.7 years
STANDARD_DEVIATION 11.8
Body Mass Index (BMI)25.8 kg/m^2
STANDARD_DEVIATION 3.5
25.6 kg/m^2
STANDARD_DEVIATION 3.6
25.5 kg/m^2
STANDARD_DEVIATION 3.8
Concomitant Procedures
Iliopsoas lengthening
5 Participants16 Participants11 Participants
Concomitant Procedures
IT band windowing/trochanteric bursectomy
11 Participants17 Participants6 Participants
Concomitant Procedures
Loose body removal
0 Participants1 Participants1 Participants
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
37 participants70 participants33 participants
Sex: Female, Male
Female
25 Participants44 Participants19 Participants
Sex: Female, Male
Male
12 Participants26 Participants14 Participants
Smoking Status
No
35 Participants65 Participants30 Participants
Smoking Status
Yes
2 Participants5 Participants3 Participants
Surgical duration43.9 minutes
STANDARD_DEVIATION 13.7
43.2 minutes
STANDARD_DEVIATION 11.7
42.4 minutes
STANDARD_DEVIATION 9.5
Time to recovery172 minutes
STANDARD_DEVIATION 40.5
172 minutes
STANDARD_DEVIATION 41.2
172 minutes
STANDARD_DEVIATION 42

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

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

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

Population: Patients that failed to complete the necessary follow up for all time points following discharge (6 hrs/18 hrs/24 hrs/48 hrs) were excluded from final analysis for the respective time points

ArmMeasureGroupValue (MEAN)
Morphine With ClonidineOpioid Consumption in the Acute Postoperative PeriodIntraoperative57.3 milligram morphine equivalents (mEq)
Morphine With ClonidineOpioid Consumption in the Acute Postoperative Period6 hours Post Discharge5.5 milligram morphine equivalents (mEq)
Morphine With ClonidineOpioid Consumption in the Acute Postoperative PeriodPACU37.0 milligram morphine equivalents (mEq)
Morphine With ClonidineOpioid Consumption in the Acute Postoperative Period18 hours Post Discharge14.5 milligram morphine equivalents (mEq)
Morphine With ClonidineOpioid Consumption in the Acute Postoperative Period7 days Post Discharge50.7 milligram morphine equivalents (mEq)
Morphine With ClonidineOpioid Consumption in the Acute Postoperative Period24 hours Post Discharge19.5 milligram morphine equivalents (mEq)
Morphine With ClonidineOpioid Consumption in the Acute Postoperative Period48 hours Post Discharge27.7 milligram morphine equivalents (mEq)
Normal SalineOpioid Consumption in the Acute Postoperative Period24 hours Post Discharge20.0 milligram morphine equivalents (mEq)
Normal SalineOpioid Consumption in the Acute Postoperative PeriodPACU40.1 milligram morphine equivalents (mEq)
Normal SalineOpioid Consumption in the Acute Postoperative Period48 hours Post Discharge35.6 milligram morphine equivalents (mEq)
Normal SalineOpioid Consumption in the Acute Postoperative Period7 days Post Discharge73.8 milligram morphine equivalents (mEq)
Normal SalineOpioid Consumption in the Acute Postoperative Period6 hours Post Discharge5.3 milligram morphine equivalents (mEq)
Normal SalineOpioid Consumption in the Acute Postoperative Period18 hours Post Discharge13.8 milligram morphine equivalents (mEq)
Normal SalineOpioid Consumption in the Acute Postoperative PeriodIntraoperative56.0 milligram morphine equivalents (mEq)
Secondary

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

Time frame: Preoperative to 24 hrs. post operatively

ArmMeasureGroupValue (MEAN)
Morphine With ClonidineQuality of Recovery (QoR-15) Scores for Patient Reported Recovery Following SurgeryPreoperative QoR-15 Score123 score on a scale
Morphine With ClonidineQuality of Recovery (QoR-15) Scores for Patient Reported Recovery Following SurgeryChange in QoR-15 Score at 24 hrs. Post Op-22 score on a scale
Normal SalineQuality of Recovery (QoR-15) Scores for Patient Reported Recovery Following SurgeryPreoperative QoR-15 Score131 score on a scale
Normal SalineQuality of Recovery (QoR-15) Scores for Patient Reported Recovery Following SurgeryChange in QoR-15 Score at 24 hrs. Post Op-20 score on a scale
Secondary

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

Time frame: Immediately preoperative (5-10 minutes before surgery), immediately postoperative (5-10 minutes after surgery), 1 hr post operatively

ArmMeasureGroupValue (MEAN)
Morphine With ClonidineVisual Analog Scale (VAS) Pain ScoresPreoperative VAS Pain Score2 score on a scale
Morphine With ClonidineVisual Analog Scale (VAS) Pain ScoresImmediate Post Op VAS Pain Score3 score on a scale
Morphine With ClonidineVisual Analog Scale (VAS) Pain Scores1 hr. Post Op VAS Pain Score4 score on a scale
Normal SalineVisual Analog Scale (VAS) Pain ScoresPreoperative VAS Pain Score2 score on a scale
Normal SalineVisual Analog Scale (VAS) Pain Scores1 hr. Post Op VAS Pain Score5 score on a scale
Normal SalineVisual Analog Scale (VAS) Pain ScoresImmediate Post Op VAS Pain Score4 score on a scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026