Immediate Post-operative Recovery After Regional vs. General Anesthesia

Outcome Clinical Trial

Official title:

Immediate Post-operative Outcome After Regional vs. General Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03047148
• Other study ID #: BASEC 2016-01869
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: May 1, 2018

Study information

• Verified date: May 2018
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1880
• Est. completion date: May 1, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Outcome

Intervention

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.

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Institue of Anesthesiology	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

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