PAKMAN
Research type
Research Study
Full title
Intravenous vs. epidural analgesia to reduce the incidence of gastrointentinal complications after elective pancreatoduodenectomy. Adaptive pragmatic randomised, controlled multicenter superiority trial with two parallel study groups (RCT).
IRAS ID
195831
Contact name
Christopher Halloran
Contact email
Sponsor organisation
Heidelberg University
Clinicaltrials.gov Identifier
DRKS00007784, German Clinical Trials Register (GermanCTR)
Duration of Study in the UK
1 years, 9 months, 30 days
Research summary
This is an adaptive pragmatic randomised controlled multicenter superiority trial of two different standard pain treatments following elective pancreatoduodenectomy.
The objective of this trial is to investigate whether the frequency of gastrointestinal complications following pancreatoduodenectomy may be reduced by 15% with postoperative patient - controlled intravenous analgesia compared to thoracic epidural analgesia.
570 patient will be assessed for eligibility. 370 patients will be randomised (this includes a 25% drop out rate) therefore 278 patients will be included in the analysis. Patients will be recruited from 8 German centres and 3 international centres, one being the UK (Royal Liverpool University Hospital).
Patients scheduled for elective pancreatoduodenectomy who provide written informed consent will be randomised to one of the following interventions:
Experimental interventions: Intraoperative general anesthesia and postoperative patient-controlled intravenous analgesia (IV-PCA).
Control intervention: Combined intraoperative general and epidural anesthesia and postoperative epidural analgesia (EDA).
Patients will be randomised on the day before surgery by authorised personnel only. On the day of surgery assessments of intraoperative and perioperative parameters along with serious adverse events will be performed.
Duration of epidural and PCA will be in accordance to local practice.
Patients will be followed up for 30 days after pancreatoduodenectomy with follow-up visits scheduled on postoperative days 2, 4, 7, and on day 14 or the day of discharge (whichever occurs first). These visit are carried out during the hospital stay. The final visit is scheduled as a telephone interview 30 days after pancreatoduodenectomy.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
16/NW/0090
Date of REC Opinion
29 Feb 2016
REC opinion
Favourable Opinion