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NCT04254523
Programmed Intermittent Bolus Versus Continuous Infusion for Epidural Analgesia in Abdominal Surgery
NA trial testing Programmed intermittent epidural bolus (PIEB) of bupicavaine in Analgesia, Epidural in 88 participants. Completed in 1 December 2020.
23 May 2020
Quick facts
| Lead sponsor | CHU de Quebec-Universite Laval |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | other |
| Enrollment | 88 |
| Start date | 14 November 2019 |
| Primary completion | 23 May 2020 |
| Estimated completion | 1 December 2020 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Programmed intermittent epidural bolus (PIEB) of bupicavaine
- Continuous epidural infusion (CEI) of bupivacaine
- Continuous epidural infusion (CEI) of morphine
Conditions studied
- Analgesia, Epidural — all drugs for Analgesia, Epidural →
- Pain, Postoperative — all drugs for Pain, Postoperative →
Sponsor
CHU de Quebec-Universite Laval — full company profile →
Who can join
18 and older, any sex, with Analgesia, Epidural or Pain, Postoperative. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Epidural analgesia is an efficient way to relieve pain after major abdominal surgery. Two different protocols are used to provide analgesia: continuous epidural infusion (CEI) and programmed intermittent boluses (PIEB). CEI consists in the delivery of a continuous administration of the intended hourly dose. PIEB consists in the administration of sequential high pressure boluses of the intended dose. Although some studies in the postoperative setting have observed that PIEB reduces the total dose needed to ensure adequate pain control, the clinical value of this finding is still uncertain. Moreover, nursing and medical interventions to the epidural infusion rates are frequently needed in the first 48 postoperative hours to optimize the provision of analgesia. These interventions add to the already important nursing workload associated with major abdominal surgery, and are correlated with suboptimal analgesia for the patient. This randomized controlled trial aims to compare the effect of epidural PIEB on the workload as a reflection of adequate analgesia compared to the standard CEI protocol in use. The investigators hypothesize that the use of PIEB decreases the number of interventions needed to obtain adequate analgesia.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04254523
- Europe PMC full search
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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 NCT04254523 (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 CHU de Quebec-Universite Laval
- Last refreshed: 20 January 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/NCT04254523.
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