Trial · NCT01116583
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Persistent post surgical pain | 3 months after surgery | Pain is assessed by means of the Brief Pain Inventory (BPI-SF) and The McGill Pain Questionnaire (SF-MPQ). Persistent postoperative pain is measured both on a 11-point numeric pain rating scale and on a 10 cm visual analog scale (VAS). A score \>=3 is considered as moderate pain. |
| Primary | Acute postoperative pain | Within the first 5 postoperative days | Acute postoperative pain is measured on a 11-point numeric rating scale both at rest and when coughing/sitting up. General pain intensity and specific (shoulder) pain intensity are measured. On postoperative day 4 pain is furthermore assessed by means of the Brief Pain Inventory (BPI-SF) and The McGill Pain Questionnaire (SF-MPQ). A score \>=3 is considered as moderate pain. |
| Primary | Usage of epidural infusion of local and opioid analgesics (ml) | Within the first 5 postoperative days | |
| Primary | Persistent post surgical pain | 6 months following surgery | Pain is assessed by means of the Brief Pain Inventory (BPI-SF) and The McGill Pain Questionnaire (SF-MPQ). Persistent postoperative pain is measured both on a 11-point numeric pain rating scale and on a 10 cm visual analog scale (VAS). A score \>=3 is considered as moderate pain. |
| Primary | Persistent post surgical pain | 12 months following surgery | Pain is assessed by means of the Brief Pain Inventory (BPI-SF) and The McGill Pain Questionnaire (SF-MPQ). Persistent postoperative pain is measured both on a 11-point numeric pain rating scale and on a 10 cm visual analog scale (VAS). A score \>=3 is considered as moderate pain. |
| Primary | Early postoperative pain | 14 days (+/-3 days) following discharge | Early postoperative pain is measured on day 14 (+/-3 days) following discharge pain using the Brief Pain Inventory (BPI-SF) and The McGill Pain Questionnaire (SF-MPQ). A score \>=3 is considered as moderate pain. |
| Secondary | Consumption of opioid analgesics | Within the first 5 postoperative days | |
| Secondary | Time to first request for additional analgesics | Within the first 5 postoperative days | |
| Secondary | Analgesia related side-effects | Within the first 5 postoperative days | Evaluation of the presence and/or severity of confusion, hallucinations, nausea, vomiting, usage of antiemetic drugs, urinary retention, sedation, pruitus, headache, respiratory depression, motor blockade and dizziness |
| Secondary | Convalescence of gastrointestinal function | Within the first 5 postoperative days | Convalescence of gastrointestinal function (time to first defecation) |
| Secondary | Health related quality of life | Day 14 (+/-3 days) following discharge | Health related quality of life is measured with the EORCT QLQ-C30 and EORCT QLQ-LC13 questionnaires. |
| Secondary | Patient satisfaction | Within the first 5 postoperative days | Patient satisfaction is assesed with the EORCT-INPATSAT32 questionnaire |
| Secondary | Intensity of preoperative anxiety | 2 hours after administration of the first dose of study medication | Anxiety is measured on a 11-point numeric rating scale (NRS). |
| Secondary | Convalescence of lung function (spirometry) | Within the first five postoperative days | FVC, FEV-1 and PEF is measured. |
| Secondary | Sleep quality | Within the first five postoperative days | Sleep quality is measured on a 11-point numeric rating scale (NRS) |
| Secondary | Walking distance (meters) | Postoperative day 3 | Ability to walk is measured by means of the 6-minutes walking test on postoperative day 3. |
| Secondary | Fatigue | Within the first 5 postoperative days | Fatigue is measured on a 4-point verbal rating scale (0=None, 1=Mild, 2=Moderate, 3=Severe). |
| Secondary | Hospital length of stay (days) | At time of discharge | |
| Secondary | Health related quality of life | 3 months following surgery | Health related quality of life is measured with the EORCT QLQ-C30 and EORCT QLQ-LC13 questionnaires. |
| Secondary | Health related quality of life | 6 months following surgery | Health related quality of life is measured with the EORCT QLQ-C30 and EORCT QLQ-LC13 questionnaires. |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT01116583/registered