Trial · NCT06828601
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Feasibility of Study for future larger RCT-Recruitment | Through study completion, an average of 6 months | Recruitment rate (screening and recruitment of 20 patients over 6 months) |
| Primary | Feasibility of Study for future larger RCT-Preliminary Data | Through study completion, an average of 6 months | Review of preliminary data for calculation of a sample size, minimum number of subjects needed to enroll in a future RCT for adequate power. |
| Primary | Feasibility of Study for future larger RCT-Acceptability of Intervention | Through study completion, an average of 6 months | Review of randomization and blinding processes, including both patients and clinical provider's experience |
| Primary | Feasibility of Study for future larger RCT-Data collection | Through study completion, an average of 6 months | The suitability of the methods for data collection, which are In person visits at 24, 48 \& 72hr and likely phone/virtual follow-ups at 2 weeks and 3 months |
| Primary | Feasibility of Study for future larger RCT-Reliability of data | Through study completion, an average of 6 months | The reliability of data collected for analysis of analgesic efficacy includes review of numerical pain scores, total morphine equivalent dose (MED), Quality of Recovery Scores (QoR-15), and Brief Pain Inventory (BPI). Analgesic efficacy is expressed as the NNT, the number of patients who need to receive the active drug for one to achieve at least 50% pain relief compared with placebo over a 4-6h treatment period. |
| Primary | Feasibility of Study for future larger RCT-Outcomes | Through study completion, an average of 6 months | Review of current Secondary Outcome to determine if appropriate to become Primary Outcomes for future RCT |
| Primary | Feasibility of Study for future larger RCT-Complete Data collection | Through study completion, an average of 6 months | Determine completion rate of collected data |
| Secondary | Length of Hospital Stay | Up to 50 weeks | This is calculated from the date admitted to the hospital to the date of hospital discharge. |
| Secondary | Adverse effects of lidocaine infusion | 48 hours - During the lidocaine infusion | |
| Secondary | Total MED | MED assessed at 24-, 48-, and 72-hours post-operatively | MED=Morphine Equivalent Dose. MED are values that represent the potency of an opioid dose relative to morphine. MED equates the many different opioids into a standard value that is based on morphine and its potency. |
| Secondary | Pain Scores | Scores assessed at 24-, 48-, and 72-hours post-operatively | Pain Scores at rest and at movement provided by participant will be a numerical pain score from 0-10, with 0=no pain and 10-worst pain imaginable. |
| Secondary | Quality of Recovery Scores | Assessed 24-, 48-, and 72-hours post-operatively | The Quality of Recovery-15 (QoR-15) is a patient-reported outcome measurement measuring QoR after surgery and anesthesia. The scale is arbitrary and ranges from 0-150 with 4 severity classes; excellent, good, moderate, and poor recovery. |
| Secondary | Brief Pain Inventory (Short Form) | Assessed at 2 weeks post-operatively and at 3 months post-operatively | The Brief Pain Inventory-Short Form (BPI) is a 9-item self-administered questionnaire which rapidly assesses the severity of pain and it's impact on functioning. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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