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NCT03339284
QLB and Laparoscopic Nephrectomy, Postoperative Pain and Recovery
Phase 4 trial testing Dexamethasone sodium phosphate in Postoperative Pain in 90 participants. Status unknown.
31 December 2022
Quick facts
| Lead sponsor | Tampere University Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 90 |
| Start date | 4 December 2017 |
| Primary completion | 31 December 2022 |
| Estimated completion | 30 June 2023 |
| Sites | 1 location across Finland |
Drugs / interventions tested
- Dexamethasone sodium phosphate (dexamethasone phosphate) — full drug profile →
- Ropivacaine Hydrocloride — full drug profile →
- Sodium Chloride 9mg/mL — full drug profile →
Conditions studied
- Postoperative Pain — all drugs for Postoperative Pain →
- Chronic Pain Post-Proceduraal — all drugs for Chronic Pain Post-Proceduraal →
- Nausea and Vomiting, Postoperative — all drugs for Nausea and Vomiting, Postoperative →
Sponsor
Tampere University Hospital
Who can join
Adults 18 to 85, any sex, with Postoperative Pain or Chronic Pain Post-Proceduraal. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
There are ca 900 new cases of kidney cancer in Finland/year. The curative therapy for kidney cancer is partial or total nephrectomy depending on the localization and the size of tumor. Main of these operations are laparoscopic. Epidural analgesia is considered as most effective for the treatment of postoperative pain after open nephrectomy, but after laparoscopic operation parenteral and enteral opioids combined with paracetamol (acetaminophen) usually offer adequate postoperative pain relief. However, the need for opioids postoperatively may be high and side effects, such as sedation and nausea, are common. On the other hand epidural analgesia has some contraindications and risks for serious complications. Nevertheless, inadequately treated acute postoperative pain is considered as one of the main risk factors for persistent postoperative pain. Recently quadratus lumborum block (QLB) has gained popularity in the treatment of postoperative pain after various surgeries in the area from hip to mamilla. It is more beneficial than other peripheral blocks, since it covers also the visceral nerves. A single shot QLB has reported to last up to 48 hours. Perineural dexamethasone added to local anesthetic has been reported to prolong the duration of analgesia of the perineural nerve block, but it's effect on the duration of QLB is not known. 90 kidney cancer patients with planned laparoscopic nephrectomy aging 18-85 will be recruited based on a power calculation. The primary outcome measure is the postoperative cumulative opioid consumption. Secondary outcomes are acute pain (NRS scale), nausea, vomiting, mobilisation and long term outcomes such as quality of life and persistent pain.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03339284
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Other Tampere University Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03339284 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Tampere University Hospital
- Last refreshed: 23 December 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03339284.
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