Clinical trial NCT03047148: Immediate Post-operative Recovery After Regional vs. General Anesthesia
Official title: Immediate Post-operative Outcome After Regional vs. General Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Outcome
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 1880
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospital records from patients after surgery in regional anesthesia that have postoperative quality control data plus a same sized matched pairs control group after general anesthesia.

Brief summary: Early post-anesthesia status of patients emerging from surgery encompasses vital respiratory and hemodynamic parameters as well as subjective signs of well-being such as absence of nausea, vomiting and a low pain level. This investigation intends to compare the rate of postoperative complications in the 2 groups from pair matched patient records after regional anesthesia with otherwise similar patients after general anesthesia.

Detailed description: It is still unclear whether the immediate post-operative condition of patients after surgery and anesthesia is dependent on the basic anesthesia technique (General vs. regional anesthesia). The patients' post-anesthesia presentation encompasses vital respiratory and hemodynamic parameters as well as subjective signs of well-being such as absence of nausea, vomiting and a low pain level. By pair matching of patient records after regional anesthesia with otherwise similar patients after general anesthesia (control group), the rate of postoperative complications in the 2 groups will be compared. The results of this investigation will help to answer what is the difference in complication rates and wellbeing of patients depending on their previous anesthesia. The results of this study will Show which basic anesthesia technique has more or less early complications.

Eligibility criteria: Inclusion Criteria:

* Records from regional anesthesia cases on adults which have quality control assessment data, plus the same number of matched pairs who had general anesthesia.

Exclusion Criteria:

* Cases with incomplete quality control assessment data.

Primary outcomes:
measure: Postoperative complications during inhospital stay up to 30 days
timeFrame: 1 March to 30 November 2017
measure: Postoperative complications during inhospital stay up to 30 days (PONV) - Duration of pain (VAS > 3) episodes in hours; days up to discharge or max. 30 days
timeFrame: 1 March to 30 November 2017
measure: Postoperative complications during inhospital stay up to 30 days (pain)
timeFrame: 1 March to 30 November 2017
Secondary outcomes:
measure: Length of hospital stay
timeFrame: 1 March to 30 November 2017
measure: Postoperative mortality
timeFrame: 1 March to 30 November 2017
measure: Total in-hospital costs
timeFrame: 1 March to 30 November 2017
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Institue of Anesthesiology
state: ZH
Study officials:
References:
citation: Seims AD, VanHouwelingen L, Mead J, Mao S, Loh A, Sandoval JA, Davidoff AM, Wu J, Wang WC, Fernandez-Pineda I. Operative and Immediate Postoperative Differences Between Traditional Multiport and Reduced Port Laparoscopic Total Splenectomy in Pediatric Patients. J Laparoendosc Adv Surg Tech A. 2017 Feb;27(2):206-210. doi: 10.1089/lap.2016.0309. Epub 2016 Oct 24.
citation: Wood SG, Dabu-Bondoc S, Dai F, Mikhael H, Vadivelu N, Roberts KE. Comparison of immediate postoperative pain after transvaginal versus traditional laparoscopic cholecystectomy. Surg Endosc. 2014 Apr;28(4):1141-5. doi: 10.1007/s00464-013-3294-8.
citation: Neuman MD, Ellenberg SS, Sieber FE, Magaziner JS, Feng R, Carson JL; REGAIN Investigators. Regional versus General Anesthesia for Promoting Independence after Hip Fracture (REGAIN): protocol for a pragmatic, international multicentre trial. BMJ Open. 2016 Nov 15;6(11):e013473. doi: 10.1136/bmjopen-2016-013473.
citation: Moreira CC, Farber A, Kalish JA, Eslami MH, Didato S, Rybin D, Doros G, Siracuse JJ. The effect of anesthesia type on major lower extremity amputation in functionally impaired elderly patients. J Vasc Surg. 2016 Mar;63(3):696-701. doi: 10.1016/j.jvs.2015.09.050. Epub 2015 Nov 6.