A Phase 4 interventional study of Morphine in Knee Disease, Arthritis Knee and Pain, Acute, sponsored by The Methodist Hospital Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by The Methodist Hospital Research Institute · Phase 4, Interventional, and Treatment
The research team wants to investigate if an intraosseous injection (directly into the bone marrow) of morphine during primary total knee replacement helps with post-operative pain following primary total knee replacement surgery. For this study patients will either be randomized into one of two groups: Group 1: Receives an intraosseous injection of morphine (mixed with standard antibiotics) during their primary total knee replacement or Group 2: Serves as the control group and only receives an intraosseous injection of antibioitics during their total knee replacement. The research team will have patients fill out a symptom journal for two weeks following their surgery to measure pain levels and pain medication consumed throughout the day as well as nausea and other symptoms. Additionally, the research team will take blood samples both intraoperatively and post-operatively (10 hours post-op) to measure the level of inflammatory markers as well as morphine.
908 studies on the registry are indexed under Acute Pain; 154 are open to participants now.
This study's enrollment of 65 is below the median of 87 across 759 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →The Methodist Hospital Research Institute is the lead sponsor of 160 studies on the registry; 60 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 16 (62%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patient receives an intraosseous injection of antibiotics into the tibia as per the standard of care for primary total knee arthroplasty under the study providers.
Patient receives an intraosseous injection of antibiotics + 10mg of morphine into the tibia during their total knee arthroplasty.
Drug: Morphine
10mg of Morphine delivered Intraosseously
Post-operative Pain
Patient will fill out Visual Analog Scale pain scores three times a day for 14 days (day 1 as day of surgery) post-op in a pain journal. Levels will be compared between study groups. A higher score indicates a higher self-perceived level of pain and a lower score indicates a lower perceived level of pain for the patient. "0" representing no pain at all on the scale and "10" representing the highest pain imaginable. Scores are reported 3 times a day per day and averaged for that day. All of these scores were then averaged for the 14 day period and reported below.
Time frame: 14 days
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr) Score - Pre-operative
KOOS Jr Score patient reported outcome measure. Scale is from 0 to 100 with a 0 being total knee disability and 100 being perfect knee health.
Time frame: preoperative
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr) Score - Two Weeks Postoperative
KOOS Jr Score patient reported outcome measure. Scale is from 0 to 100 with a 0 being total knee disability and 100 being perfect knee health. Reported two-weeks post-operative.
Time frame: two week postoperatively
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr) Score - Two Weeks Postoperative
KOOS Jr Score patient reported outcome measure. Scale is from 0 to 100 with a 0 being total knee disability and 100 being perfect knee health. Reported 8 weeks post-operative.
Time frame: 8 weeks postoperatively
Recruited at hospital from 5/5/2020 through 4/1/2021
| Milestone | Control Group | Intarosseous Morphine |
|---|---|---|
| Started | 33 | 32 |
| Completed | 24 | 24 |
| Not completed | 9 | 8 |
| Withdrew: Lost to follow-up | 5 | 3 |
| Withdrew: Adverse event | 1 | 1 |
| Withdrew: Protocol violation | 2 | 4 |
| Withdrew: Withdrawal by subject | 1 | 0 |
Patient will fill out Visual Analog Scale pain scores three times a day for 14 days (day 1 as day of surgery) post-op in a pain journal. Levels will be compared between study groups. A higher score indicates a higher self-perceived level of pain and a lower score indicates a lower perceived level of pain for the patient. "0" representing no pain at all on the scale and "10" representing the highest pain imaginable. Scores are reported 3 times a day per day and averaged for that day. All of these scores were then averaged for the 14 day period and reported below.
| visual analog pain scale | Control Group | Intarosseous Morphine |
|---|---|---|
| Post-operative Pain | 4.29 ± 0.39 | 3.57 ± 0.37 |
KOOS Jr Score patient reported outcome measure. Scale is from 0 to 100 with a 0 being total knee disability and 100 being perfect knee health.
| KOOS Jr. Score | Control Group | Intarosseous Morphine |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr) Score - Pre-operative | 52.0 ± 2.0 | 51.4 ± 2.1 |
KOOS Jr Score patient reported outcome measure. Scale is from 0 to 100 with a 0 being total knee disability and 100 being perfect knee health. Reported two-weeks post-operative.
| KOOS Jr. Score | Control Group | Intarosseous Morphine |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr) Score - Two Weeks Postoperative | 57.1 ± 2.0 | 62.2 ± 2.1 |
KOOS Jr Score patient reported outcome measure. Scale is from 0 to 100 with a 0 being total knee disability and 100 being perfect knee health. Reported 8 weeks post-operative.
| KOOS Jr. Score | Control Group | Intarosseous Morphine |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr) Score - Two Weeks Postoperative | 64.0 ± 2.2 | 71.5 ± 2.3 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Group | 0/24 (0%) | 1/24 (4.2%) | 0/24 (0%) |
| Intarosseous Morphine | 0/24 (0%) | 1/24 (4.2%) | 0/24 (0%) |
| Event | Control Group | Intarosseous Morphine |
|---|---|---|
| Pulmonary EmbolismBlood and lymphatic system disorders | 1/24 | 1/24 |
| Age, Continuous(years) | Control Group | Intarosseous Morphine | Total |
|---|---|---|---|
| Mean | 65.06 ± 6.37 | 65.20 ± 8.01 | 65.13 ± 7.16 |
| Sex: Female, Male(Participants) | Control Group | Intarosseous Morphine | Total |
|---|---|---|---|
| Female | 11 | 15 | 26 |
| Male | 13 | 9 | 22 |
| Race and Ethnicity Not Collected(Participants) | Control Group | Intarosseous Morphine | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Control Group | Intarosseous Morphine | Total |
|---|---|---|---|
| United States | 24 | 24 | 48 |
| Weight (kg)(KG) | Control Group | Intarosseous Morphine | Total |
|---|---|---|---|
| Mean | 96.03 ± 21.74 | 88.13 ± 15.99 | 92.08 ± 19.29 |
| BMI(KG/m^2) | Control Group | Intarosseous Morphine | Total |
|---|---|---|---|
| Mean | 30.58 ± 3.89 | 31.36 ± 5.09 | 30.97 ± 4.50 |
Documents are hosted by the registry — open the source record to download them.
Ran from May 2020 to primary completion in Apr 2021, 11 months.
Results were first posted in Sep 2024, 3 years 4 months after primary completion.
Of 71 non-industry phase 4 interventional studies under Acute Pain, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 32. This study's 11 months is below that.
Counting every sponsor, half of 76 studies reached it within 19 months; a quarter within 9 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Morphine
The Methodist Hospital Research Institute →