Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 58 of 325 for:    clonidine

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02530151
Recruitment Status : Completed
First Posted : August 20, 2015
Results First Posted : May 20, 2019
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Michael Terry, Northwestern University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions Femoracetabular Impingement
Pain, Postoperative
Interventions Drug: Morphine with clonidine
Other: Normal saline
Enrollment 70
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Morphine With Clonidine Normal Saline
Hide Arm/Group Description

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

11 mL intra-articular injection of .9% NaCl solution at conclusion of hip arthroscopy procedure

Normal saline: see arm description

Period Title: Overall Study
Started 37 33
Completed 16 17
Not Completed 21 16
Arm/Group Title Morphine With Clonidine Normal Saline Total
Hide Arm/Group Description

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

11 mL intra-articular injection of .9% NaCl solution at conclusion of hip arthroscopy procedure

Normal saline: see arm description

Total of all reporting groups
Overall Number of Baseline Participants 37 33 70
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants 33 participants 70 participants
40.7  (12.9) 36.7  (11.8) 38.8  (12.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 33 participants 70 participants
Female
25
  67.6%
19
  57.6%
44
  62.9%
Male
12
  32.4%
14
  42.4%
26
  37.1%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 37 participants 33 participants 70 participants
37 33 70
Smoking Status  
Measure Type: Count of Participants
Unit of measure:  Participants
No Number Analyzed 37 participants 33 participants 70 participants
35
  94.6%
30
  90.9%
65
  92.9%
Yes Number Analyzed 37 participants 33 participants 70 participants
2
   5.4%
3
   9.1%
5
   7.1%
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 37 participants 33 participants 70 participants
25.8  (3.5) 25.5  (3.8) 25.6  (3.6)
Surgical duration  
Mean (Standard Deviation)
Unit of measure:  Minutes
Number Analyzed 37 participants 33 participants 70 participants
43.9  (13.7) 42.4  (9.5) 43.2  (11.7)
Concomitant Procedures  
Measure Type: Count of Participants
Unit of measure:  Participants
Iliopsoas lengthening Number Analyzed 37 participants 33 participants 70 participants
5
  13.5%
11
  33.3%
16
  22.9%
IT band windowing/trochanteric bursectomy Number Analyzed 37 participants 33 participants 70 participants
11
  29.7%
6
  18.2%
17
  24.3%
Loose body removal Number Analyzed 37 participants 33 participants 70 participants
0
   0.0%
1
   3.0%
1
   1.4%
Time to recovery  
Mean (Standard Deviation)
Unit of measure:  Minutes
Number Analyzed 37 participants 33 participants 70 participants
172  (40.5) 172  (42) 172  (41.2)
1.Primary Outcome
Title Opioid Consumption in the Acute Postoperative Period
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Morphine With Clonidine Normal Saline
Hide Arm/Group Description:

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

11 mL intra-articular injection of .9% NaCl solution at conclusion of hip arthroscopy procedure

Normal saline: see arm description

Overall Number of Participants Analyzed 37 33
Mean (95% Confidence Interval)
Unit of Measure: milligram morphine equivalents (mEq)
Intraoperative Number Analyzed 37 participants 33 participants
57.3
(50.6 to 63.9)
56.0
(47.6 to 64.4)
PACU Number Analyzed 37 participants 33 participants
37.0
(28.8 to 45.3)
40.1
(31.8 to 48.4)
6 hours Post Discharge Number Analyzed 17 participants 16 participants
5.5
(3.7 to 7.3)
5.3
(3.0 to 7.6)
18 hours Post Discharge Number Analyzed 17 participants 16 participants
14.5
(10.6 to 18.4)
13.8
(8.7 to 18.9)
24 hours Post Discharge Number Analyzed 17 participants 16 participants
19.5
(13.9 to 25.1)
20.0
(12.1 to 27.8)
48 hours Post Discharge Number Analyzed 17 participants 16 participants
27.7
(19.5 to 35.9)
35.6
(18.3 to 52.9)
7 days Post Discharge Number Analyzed 17 participants 16 participants
50.7
(29.6 to 71.7)
73.8
(31.6 to 115.9)
2.Secondary Outcome
Title Visual Analog Scale (VAS) Pain Scores
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Morphine With Clonidine Normal Saline
Hide Arm/Group Description:

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

11 mL intra-articular injection of .9% NaCl solution at conclusion of hip arthroscopy procedure

Normal saline: see arm description

Overall Number of Participants Analyzed 37 33
Mean (95% Confidence Interval)
Unit of Measure: score on a scale
Preoperative VAS Pain Score
2
(1 to 3)
2
(1 to 3)
Immediate Post Op VAS Pain Score
3
(2 to 4)
4
(3 to 5)
1 hr. Post Op VAS Pain Score
4
(3 to 5)
5
(4 to 5)
3.Secondary Outcome
Title Quality of Recovery (QoR-15) Scores for Patient Reported Recovery Following Surgery
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Morphine With Clonidine Normal Saline
Hide Arm/Group Description:

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

11 mL intra-articular injection of .9% NaCl solution at conclusion of hip arthroscopy procedure

Normal saline: see arm description

Overall Number of Participants Analyzed 37 33
Mean (95% Confidence Interval)
Unit of Measure: score on a scale
Preoperative QoR-15 Score
123
(108 to 138)
131
(125 to 137)
Change in QoR-15 Score at 24 hrs. Post Op
-22
(-35 to -9)
-20
(-29 to -10)
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events were not monitored or assessed for any study participants due to the nature of the hip arthroscopy procedure and the study procedures at large
 
Arm/Group Title Morphine With Clonidine Normal Saline
Hide Arm/Group Description

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

11 mL intra-articular injection of .9% NaCl solution at conclusion of hip arthroscopy procedure

Normal saline: see arm description

All-Cause Mortality
Morphine With Clonidine Normal Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
Morphine With Clonidine Normal Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Morphine With Clonidine Normal Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael Terry, MD
Organization: Northwestern University
Phone: 312-472-6488
EMail: mterry@nm.org
Layout table for additonal information
Responsible Party: Michael Terry, Northwestern University
ClinicalTrials.gov Identifier: NCT02530151     History of Changes
Other Study ID Numbers: STU00201218
First Submitted: August 18, 2015
First Posted: August 20, 2015
Results First Submitted: April 19, 2019
Results First Posted: May 20, 2019
Last Update Posted: September 23, 2019