Primary outcomeNumber· The first day after hospital discharge
Comparison of Adjusted Trajectory Model for Pain Between Oxytocin and Placebo--Intercept
| Group | Value (score on a scale) |
|---|---|
| Oxytocin | 8.5 |
| Placebo | 8.6 |
Trial · Interventional
TerminatedPhase 2Results postedRegistry dataEfficacy of Intrathecal Oxytocin to Speed Recovery After Hip Surgery
NCTNCT03011307 (opens ClinicalTrials.gov in a new tab)Other idIRB00036246
This trial was stopped early.
Reason given at the registry: Cessation of funding period prior to completion, due to slow recruitment during the pandemic.
Results were posted for this trial.
Overview
- Status
- Terminated
- Phase
- Phase 2
- Enrollment
- 126 participants (actual)
- Sponsor
- Wake Forest University Health Sciences · Other
- Design
- Randomized · Triple masking
- Countries
1 country
United States
- Start
- 12 Jan 2017
- Primary completion
- 23 Oct 2020
- Completion
- 11 Aug 2021
- First posted
- 5 Jan 2017 (estimated)
- Last update posted
- 23 Nov 2022
- Conditions
- Postoperative Pain
Timeline
1 trial · 1 stopped early · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201720182019202020212022
- Ph 2Terminated
Efficacy of Intrathecal Oxytocin to Speed Recovery After Hip Surgery
NCT0301130712 Jan 2017 to 11 Aug 2021
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this study is to determine the effect of intrathecal oxytocin on speed of reduction in pain for the first 60 days after hip surgery.
Interventions
- OxytocinDrug
- PlaceboDrug
Arms2
Experimental
Oxytocin
Oxytocin 100 micrograms administered intrathecally
Placebo comparator
Placebos
Placebo injection administered intrathecally
Primary outcomes2
Outcomes the sponsor listed as primary.
Comparison of Adjusted Trajectory Model for Pain Between Oxytocin and Placebo--Intercept
Time frame · The first day after hospital discharge
Registry description
Daily pain intensity report for each subject was fitted using growth curve model with parameters of intercept (modeled initial pain) and slope of change in natural log of time, adjusted for prognostic predictors for oxytocin and placebo group separately. The daily pain intensity was the WORST pain (not the average pain) in the past 24 hr on a scale where 0 is no pain and 10 is worst imaginable pain. Values represent an intercept of modeled worst daily pain on the first day after hospital discharge across all participants, extracted from the mixed effect model. The intercept is a number representative of all participants in the Arm and is an estimate with confidence limits based on the model.
Comparison of Adjusted Trajectory Model for Pain Between Oxytocin and Placebo--Slope
Time frame · Postoperative Day 1 through Postoperative Day 60
Registry description
Daily pain intensity report for each subject was fitted using growth curve model with parameters of intercept (modeled initial pain) and slope of change in natural log of time, adjusted for prognostic predictors for oxytocin and placebo group separately. The daily pain intensity was the WORST pain in the past 24 hr on a scale where 0 is no pain and 10 is worst imaginable pain. Slope is defined as change in pain . Values represent the slope of modeled worst daily pain (0-10 scale as described above) divided by the natural log of time (days) across all participants, extracted from the mixed effect model. The slope is a number representative of all participants in the Arm and is an estimate with confidence limits based on the model.
Secondary outcomes(9)
Comparison of Adjusted Trajectory Model for Daily Steps Between Oxytocin and Placebo--Intercept
Time frame · The first day after hospital discharge
Registry description
Daily steps for each subject were fitted using growth curve model with parameters of intercept (modeled initial steps) and slope of change in natural log of time, adjusted for prognostic predictors for oxytocin and placebo group separately. This is considered as the modeled change in activity listed in the protocol. Values represent an intercept of modeled daily steps on the first day after hospital discharge across all participants, extracted from the mixed effect model. The intercept is a number representative of all participants in the Arm and is an estimate with confidence limits based on the model.
Comparison of Adjusted Trajectory Model for Daily Steps Between Oxytocin and Placebo--Slope
Time frame · Postoperative Day 1 through Postoperative Day 60
Registry description
Daily steps for each subject were fitted using growth curve model with parameters of intercept (modeled initial steps) and slope of change in natural log of time, adjusted for prognostic predictors for oxytocin and placebo group separately. This is considered as the modeled change in activity listed in the protocol. Values represent the slope of daily steps divided by the natural log of time (days) across all participants, extracted from the mixed effect model. The slope is a number representative of all participants in the Arm and is an estimate with confidence limits based on the model.
Comparison of Adjusted Trajectory Model for World Health Organization Disability Assessment Score 2.0 Value Between Oxytocin and Placebo--Intercept
Time frame · Modeled WHODAS 2.0 one week after hospital discharge
Registry description
Weekly World Health Organization Disability Assessment Score 2.0 (WHODAS 2.0) value for each subject was fitted using growth curve model with parameters of intercept (modeled initial score) and slope of change in natural log of time, adjusted for prognostic predictors for oxytocin and placebo group separately. Scale is 12 to 36 with higher scores meaning greater disability. Values represent an intercept of modeled WHODAS 2.0 score one week after hospital discharge across all participants, extracted from the mixed effect model. The intercept is a number representative of all participants in the Arm and is an estimate with confidence limits based on the model.
Comparison of Adjusted Trajectory Model for World Health Organization Disability Assessment Score 2.0 Value Between Oxytocin and Placebo--Slope
Time frame · Postoperative Day 7 through Postoperative Day 56
Registry description
Weekly World Health Organization Disability Assessment Score 2.0 (WHODAS 2.0) value for each subject was fitted using growth curve model with parameters of intercept (modeled initial score) and slope of change in natural log of time, adjusted for prognostic predictors for oxytocin and placebo group separately. Scale is 12 to 36 with higher scores meaning greater disability. Values represent the slope of WHODAS 2.0 score divided by the natural log of time (days) across all participants, extracted from the mixed effect model. The slope is a number representative of all participants in the Arm and is an estimate with confidence limits based on the model.
Comparison of Adjusted Trajectory Model for Probability of Taking Opioids Daily Between Oxytocin and Placebo--Intercept
Time frame · The first day after hospital discharge
Registry description
Daily probability of taking opioids for each subject was fitted using growth curve model with parameters of intercept (modeled initial pain) and slope of change in natural log of time, adjusted for prognostic predictors for oxytocin and placebo group separately. Values represent an intercept of modeled probability of taking opioid, on a 0-1 probability scale, on the first day after hospital discharge across all participants, extracted from the mixed effect model. The intercept is a number representative of all participants in the Arm and is an estimate with standard deviation based on the model.
Comparison of Adjusted Trajectory Model for Probability of Taking Opioids Daily Between Oxytocin and Placebo--Slope
Time frame · Postoperative Day 1 through Postoperative Day 60
Registry description
Daily probability of taking opioids for each subject was fitted using growth curve model with parameters of intercept (modeled initial pain) and slope of change in natural log of time, adjusted for prognostic predictors for oxytocin and placebo group separately. Values represent the slope of daily probability of taking opioids divided by the natural log of time (days) across all participants, extracted from the mixed effect model. The slope is a number representative of all participants in the Arm and is an estimate with confidence limits based on the model
Iowa Gambling Task
Time frame · Preoperative, 2 months after surgery
Registry description
This is a computer based card game which assesses risk taking and impulsivity in which a score of -100 to 100 is calculated. Lower numbers indicate greater impulsiivity
Wisconsin Card Sort Task
Time frame · Preoperative, 2 months after surgery
Registry description
This is a physical card sorting game which measures attention to shifts in implicit rules as the game progresses. Perseverative errors are the number of sequential errors when rules of the game shift and reflect dysfunction of attention. This score ranges from 0 to 64 with larger numbers reflecting more dysfunction of attention.
Tampa Scale of Kinesiophobia
Time frame · Preoperative, 2 months after surgery
Registry description
This 17-question scale assesses the degree of fear of pain from joint movement and is commonly used in orthopedic injury or surgery studies. The scale ranges from 17 to 68 with 17 indicating no fear of movement and 68 indicating severe fear.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeNumber· Postoperative Day 1 through Postoperative Day 60
Comparison of Adjusted Trajectory Model for Pain Between Oxytocin and Placebo--Slope
| Group | Value (Score on a scale) |
|---|---|
| Oxytocin | -1.9 |
| Placebo | -2 |
Secondary and other outcome results(6)
Secondary outcomeNumber· The first day after hospital discharge
Comparison of Adjusted Trajectory Model for Daily Steps Between Oxytocin and Placebo--Intercept
| Group | Value (Daily Steps) |
|---|---|
| Oxytocin | 144 |
| Placebo | 546 |
Secondary outcomeNumber· Postoperative Day 1 through Postoperative Day 60
Comparison of Adjusted Trajectory Model for Daily Steps Between Oxytocin and Placebo--Slope
| Group | Value (Daily steps) |
|---|---|
| Oxytocin | 562 |
| Placebo | 218 |
Secondary outcomeNumber· Modeled WHODAS 2.0 one week after hospital discharge
Comparison of Adjusted Trajectory Model for World Health Organization Disability Assessment Score 2.0 Value Between Oxytocin and Placebo--Intercept
| Group | Value (score on a scale) |
|---|---|
| Oxytocin | 23.2 |
| Placebo | 29.1 |
Secondary outcomeNumber· Postoperative Day 7 through Postoperative Day 56
Comparison of Adjusted Trajectory Model for World Health Organization Disability Assessment Score 2.0 Value Between Oxytocin and Placebo--Slope
| Group | Value (Score on a scale/ln(days)) |
|---|---|
| Oxytocin | -7.1 |
| Placebo | -5.6 |
Secondary outcomeNumber· The first day after hospital discharge
Comparison of Adjusted Trajectory Model for Probability of Taking Opioids Daily Between Oxytocin and Placebo--Intercept
| Group | Value (Probability of taking opioids) |
|---|---|
| Oxytocin | 0.9995 |
| Placebo | 0.9998 |
Secondary outcomeNumber· Postoperative Day 1 through Postoperative Day 60
Comparison of Adjusted Trajectory Model for Probability of Taking Opioids Daily Between Oxytocin and Placebo--Slope
| Group | Value (Probability of taking opioids/ln(days)) |
|---|---|
| Oxytocin | -0.953 |
| Placebo | -0.787 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| OxytocinOxytocin 100 micrograms administered intrathecally Oxytocin: spinal injection of oxytocin | 0 / 44 | 0 / 44 | 0 / 44 |
| PlaceboPlacebo injection administered intrathecally Placebos: spinal injection of placebo | 0 / 46 | 0 / 46 | 0 / 46 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 80 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Scheduled for unilateral, primary total hip replacement
* American Society of Anesthesiologists physical status 1-3
Exclusion Criteria:
* Pregnancy
* Currently Workman's Comp litigation related to hip replacement
* Taking greater than 100 milligrams of morphine (or equivalent)
* Suffering from a psychotic disorder or a recent psychiatric hospitalization
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