Condition category
Surgery
Date applied
03/12/2007
Date assigned
20/03/2008
Last edited
05/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Thomas Luecke

ORCID ID

Contact details

Clinic of Anaesthesiology and Critical Care Medicine
University Hospital Mannheim
Theodor-Kutzer-Ufer 1-3
Mannheim
68167
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Comparison of spinal anaesthesia with 1.0 mL hyperbaric bupivacaine 0.5% and total intravenous anaesthesia for minor anorectal surgery

Acronym

Study hypothesis

Minor anorectal surgery can be performed with several anaesthesia techniques. Due to multiple irrational fears, many patients deny a spinal anaesthesia and prefer a general anaesthesia. In this study we evaluate the practicability, patients' acceptability and analgetic consumption for both anaesthesia techniques in patients undergoing minor anorectal surgery.

Ethics approval

Ethics approval received from the local medical ethics committee (Medizinische Ethikkommission II Anschrift: Medizinische Ethik-Kommission II) on the 24th May 2007 (ref: 2007-085N-MA).

Study design

Single-centre, randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Minor anorectal surgery

Intervention

Patients with anorectal surgery are 1:1 randomised to either a spinal anaesthesia or a general anaesthesia. All patients received either:
1. A spinal anaesthesia with 1.0 mL hyperbaric bupivacaine 0.5% or
2. A total intravenous anaesthesia with:
2.1. 0.2 mg fentanyl and 2 mg propofol 1% per kg body weight for induction
2.2. Propofol 1% in a perfusion pump for the duration of anaesthesia, dosage depending on the demands of the patient
2.3. A laryngeal mask (size depending on the body weight of the patient)

Intervention type

Drug

Phase

Not Specified

Drug names

Fentanyl, propofol, bupivacaine

Primary outcome measures

Recovery room time, measured on day of surgery.

Secondary outcome measures

Consumption of analgetics in the first 24 hours, measured 48 hours after surgery.

Overall trial start date

01/09/2007

Overall trial end date

01/02/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients (male/female) with minor anorectal surgery
2. Operation in jack knife position
3. Age: 18 - 75 years
4. American Society of Anaesthesiologists (ASA) grade I - II
5. No contra-indication against spinal anaesthesia or general anaesthesia

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Contra-indications against spinal anaesthesia or general anaesthesia
2. Operations in prone position
3. Allergy against diclofenac

Recruitment start date

01/09/2007

Recruitment end date

01/02/2008

Locations

Countries of recruitment

Germany

Trial participating centre

Clinic of Anaesthesiology and Critical Care Medicine
Mannheim
68167
Germany

Sponsor information

Organisation

University Hospital Mannheim (Germany)

Sponsor details

Clinic of Anaesthesiology and Critical Care Medicine
Theodor-Kutzer-Ufer 1-3
Mannheim
68167
Germany
marc.schmittner@anaes.ma.uni-heidelberg.de

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19937984

Publication citations

  1. Results

    Schmittner MD, Schreiber H, Janke A, Weiss C, Blunk J, Bussen DG, Luecke T, Randomized clinical trial of perianal surgery performed under spinal saddle block versus total intravenous anaesthesia., Br J Surg, 2010, 97, 1, 12-20, doi: 10.1002/bjs.6792.

Additional files

Editorial Notes