Trial Outcomes & Findings for Intra-articular Morphine and Clonidine Injections for Pain Management in Hip Arthroscopy (NCT NCT02530151)
NCT ID: NCT02530151
Last Updated: 2019-09-23
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
70 participants
Primary outcome timeframe
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
Results posted on
2019-09-23
Participant Flow
Participant milestones
| Measure |
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
|
Normal Saline
11 mL intra-articular injection of .9% NaCl solution at conclusion of hip arthroscopy procedure
Normal saline: see arm description
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
33
|
|
Overall Study
COMPLETED
|
16
|
17
|
|
Overall Study
NOT COMPLETED
|
21
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Morphine With Clonidine
n=37 Participants
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
|
Normal Saline
n=33 Participants
11 mL intra-articular injection of .9% NaCl solution at conclusion of hip arthroscopy procedure
Normal saline: see arm description
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.7 years
STANDARD_DEVIATION 12.9 • n=37 Participants
|
36.7 years
STANDARD_DEVIATION 11.8 • n=33 Participants
|
38.8 years
STANDARD_DEVIATION 12.3 • n=70 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=37 Participants
|
19 Participants
n=33 Participants
|
44 Participants
n=70 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=37 Participants
|
14 Participants
n=33 Participants
|
26 Participants
n=70 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
37 participants
n=37 Participants
|
33 participants
n=33 Participants
|
70 participants
n=70 Participants
|
|
Smoking Status
No
|
35 Participants
n=37 Participants
|
30 Participants
n=33 Participants
|
65 Participants
n=70 Participants
|
|
Smoking Status
Yes
|
2 Participants
n=37 Participants
|
3 Participants
n=33 Participants
|
5 Participants
n=70 Participants
|
|
Body Mass Index (BMI)
|
25.8 kg/m^2
STANDARD_DEVIATION 3.5 • n=37 Participants
|
25.5 kg/m^2
STANDARD_DEVIATION 3.8 • n=33 Participants
|
25.6 kg/m^2
STANDARD_DEVIATION 3.6 • n=70 Participants
|
|
Surgical duration
|
43.9 minutes
STANDARD_DEVIATION 13.7 • n=37 Participants
|
42.4 minutes
STANDARD_DEVIATION 9.5 • n=33 Participants
|
43.2 minutes
STANDARD_DEVIATION 11.7 • n=70 Participants
|
|
Concomitant Procedures
Iliopsoas lengthening
|
5 Participants
n=37 Participants
|
11 Participants
n=33 Participants
|
16 Participants
n=70 Participants
|
|
Concomitant Procedures
IT band windowing/trochanteric bursectomy
|
11 Participants
n=37 Participants
|
6 Participants
n=33 Participants
|
17 Participants
n=70 Participants
|
|
Concomitant Procedures
Loose body removal
|
0 Participants
n=37 Participants
|
1 Participants
n=33 Participants
|
1 Participants
n=70 Participants
|
|
Time to recovery
|
172 minutes
STANDARD_DEVIATION 40.5 • n=37 Participants
|
172 minutes
STANDARD_DEVIATION 42 • n=33 Participants
|
172 minutes
STANDARD_DEVIATION 41.2 • n=70 Participants
|
PRIMARY outcome
Timeframe: 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 dischargePopulation: 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
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
Outcome measures
| Measure |
Morphine With Clonidine
n=37 Participants
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
|
Normal Saline
n=33 Participants
11 mL intra-articular injection of .9% NaCl solution at conclusion of hip arthroscopy procedure
Normal saline: see arm description
|
|---|---|---|
|
Opioid Consumption in the Acute Postoperative Period
Intraoperative
|
57.3 milligram morphine equivalents (mEq)
Interval 50.6 to 63.9
|
56.0 milligram morphine equivalents (mEq)
Interval 47.6 to 64.4
|
|
Opioid Consumption in the Acute Postoperative Period
PACU
|
37.0 milligram morphine equivalents (mEq)
Interval 28.8 to 45.3
|
40.1 milligram morphine equivalents (mEq)
Interval 31.8 to 48.4
|
|
Opioid Consumption in the Acute Postoperative Period
6 hours Post Discharge
|
5.5 milligram morphine equivalents (mEq)
Interval 3.7 to 7.3
|
5.3 milligram morphine equivalents (mEq)
Interval 3.0 to 7.6
|
|
Opioid Consumption in the Acute Postoperative Period
18 hours Post Discharge
|
14.5 milligram morphine equivalents (mEq)
Interval 10.6 to 18.4
|
13.8 milligram morphine equivalents (mEq)
Interval 8.7 to 18.9
|
|
Opioid Consumption in the Acute Postoperative Period
24 hours Post Discharge
|
19.5 milligram morphine equivalents (mEq)
Interval 13.9 to 25.1
|
20.0 milligram morphine equivalents (mEq)
Interval 12.1 to 27.8
|
|
Opioid Consumption in the Acute Postoperative Period
48 hours Post Discharge
|
27.7 milligram morphine equivalents (mEq)
Interval 19.5 to 35.9
|
35.6 milligram morphine equivalents (mEq)
Interval 18.3 to 52.9
|
|
Opioid Consumption in the Acute Postoperative Period
7 days Post Discharge
|
50.7 milligram morphine equivalents (mEq)
Interval 29.6 to 71.7
|
73.8 milligram morphine equivalents (mEq)
Interval 31.6 to 115.9
|
SECONDARY outcome
Timeframe: Immediately 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
Outcome measures
| Measure |
Morphine With Clonidine
n=37 Participants
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
|
Normal Saline
n=33 Participants
11 mL intra-articular injection of .9% NaCl solution at conclusion of hip arthroscopy procedure
Normal saline: see arm description
|
|---|---|---|
|
Visual Analog Scale (VAS) Pain Scores
Preoperative VAS Pain Score
|
2 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 3.0
|
|
Visual Analog Scale (VAS) Pain Scores
Immediate Post Op VAS Pain Score
|
3 score on a scale
Interval 2.0 to 4.0
|
4 score on a scale
Interval 3.0 to 5.0
|
|
Visual Analog Scale (VAS) Pain Scores
1 hr. Post Op VAS Pain Score
|
4 score on a scale
Interval 3.0 to 5.0
|
5 score on a scale
Interval 4.0 to 5.0
|
SECONDARY outcome
Timeframe: Preoperative 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
Outcome measures
| Measure |
Morphine With Clonidine
n=37 Participants
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
|
Normal Saline
n=33 Participants
11 mL intra-articular injection of .9% NaCl solution at conclusion of hip arthroscopy procedure
Normal saline: see arm description
|
|---|---|---|
|
Quality of Recovery (QoR-15) Scores for Patient Reported Recovery Following Surgery
Preoperative QoR-15 Score
|
123 score on a scale
Interval 108.0 to 138.0
|
131 score on a scale
Interval 125.0 to 137.0
|
|
Quality of Recovery (QoR-15) Scores for Patient Reported Recovery Following Surgery
Change in QoR-15 Score at 24 hrs. Post Op
|
-22 score on a scale
Interval -35.0 to -9.0
|
-20 score on a scale
Interval -29.0 to -10.0
|
Adverse Events
Morphine With Clonidine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Saline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place