Immediate Post-operative Recovery After Regional vs. General Anesthesia

Immediate Post-operative Outcome After Regional vs. General Anesthesia

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.

Study Overview

• Status: Completed
• Conditions: Outcome
• Intervention / Treatment: Other: Data mining from records

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.

• Study Type: Observational
• Enrollment (Actual): 1880

Contacts and Locations

Study Locations

• Switzerland
  • ZH
    • Zurich, ZH, Switzerland, 8091
      • University Hospital Zurich, Institue of Anesthesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Regional Anesthesia; Hospital records from patients who have undergone surgery in regional anesthesia.	Other: Data mining from records; The relevant data for this investigation is extracted from the patient records database as well as from the assessment results of the ongoing quality control process that were collected by the nursing staff of the postoperative recovery units.
General Anesthesia; Hospital records from patients who have undergone surgery in General anesthesia.	Other: Data mining from records; The relevant data for this investigation is extracted from the patient records database as well as from the assessment results of the ongoing quality control process that were collected by the nursing staff of the postoperative recovery units.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications during inhospital stay up to 30 days	Number participants who had one or more cardiovascular events up to discharge or 30 days	1 March to 30 November 2017
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	Number of PONV episodes up to discharge or max. 30 days Duration of PONV episodes in days; hours up to discharge or max. 30 days	1 March to 30 November 2017
Postoperative complications during inhospital stay up to 30 days (pain)	Duration of pain (VAS > 3) episodes in hours; days up to discharge or max. 30 days	1 March to 30 November 2017

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	Length of hospital stay in days up to discharge or max. 30 days	1 March to 30 November 2017
Postoperative mortality	In-patient postoperative mortality (yes or no up to 30 days)	1 March to 30 November 2017
Total in-hospital costs	Absolute amount per case in CHF according financial department report	1 March to 30 November 2017

Collaborators and Investigators

• Sponsor: University of Zurich

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): April 30, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: January 31, 2017
• First Submitted That Met QC Criteria: February 6, 2017
• First Posted (Estimate): February 8, 2017

Study Record Updates

• Last Update Posted (Actual): May 8, 2018
• Last Update Submitted That Met QC Criteria: May 7, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: BASEC 2016-01869

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD planned.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No