Continuous wound infiltration versus epidural analgesia for midline abdominal incisions - a randomized-controlled pilot trial (Painless-Pilot trial; DRKS Number: DRKS00008023).
Abdominal Injuries
/ drug therapy
Analgesia, Epidural
/ adverse effects
Anesthesia, Local
/ adverse effects
Anesthetics, Local
/ administration & dosage
Elective Surgical Procedures
/ standards
Female
Humans
Laparotomy
/ standards
Male
Middle Aged
Pain Management
/ methods
Pain Measurement
/ methods
Pain, Postoperative
/ physiopathology
Pilot Projects
Postoperative Complications
/ physiopathology
Postoperative Period
Journal
PloS one
ISSN: 1932-6203
Titre abrégé: PLoS One
Pays: United States
ID NLM: 101285081
Informations de publication
Date de publication:
2020
2020
Historique:
received:
22
01
2019
accepted:
14
02
2020
entrez:
7
3
2020
pubmed:
7
3
2020
medline:
19
6
2020
Statut:
epublish
Résumé
To test the feasibility of a randomized controlled study design comparing epidural analgesia (EDA) with continuous wound infiltration (CWI) in respect to postoperative complications and mobility to design a future multicentre randomized controlled trial. CWI has been developed to address drawbacks of EDA. Previous studies have established the equivalent analgesic potential of CWI compared to EDA. This is a single centre, non-blinded pilot randomized controlled trial at a tertiary surgical centre. Patients undergoing elective non-colorectal surgery via a midline laparotomy were randomized to EDA or CWI. Endpoints included recruitment, feasibility of assessing postoperative mobility with a pedometer and morbidity. No primary endpoint was defined and all analyses were explorative. CWI with local anaesthetics (experimental group) vs. thoracic EDA (control). Of 846 patients screened within 14 months, 71 were randomized and 62 (31 per group) included in the intention-to-treat analysis. Mobility was assessed in 44 of 62 patients and revealed no differences within the first 3 postoperative days. Overall morbidity did not differ between the two groups (measured via the comprehensive complication index). Median pain scores at rest were comparable between the two groups, while EDA was superior in pain treatment during movement on the first, but not on the second and third postoperative day. Duration of preoperative induction of anaesthesia was shorter with CWI than with EDA. Of 17 serious adverse events, 3 were potentially related to EDA, while none was related to CWI. This trial confirmed the feasibility of a randomized trial design to compare CWI and EDA regarding morbidity. Improvements in the education and training of team members are necessary to improve recruitment. DRKS00008023.
Identifiants
pubmed: 32142529
doi: 10.1371/journal.pone.0229898
pii: PONE-D-19-01995
pmc: PMC7059935
doi:
Substances chimiques
Anesthetics, Local
0
Banques de données
DRKS
['DRKS00008023']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e0229898Déclaration de conflit d'intérêts
The authors have declared that no competing interests exist.
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