Condition category
Digestive System
Date applied
11/04/2011
Date assigned
06/06/2011
Last edited
06/06/2011
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

Dr Marc D Schmittner

ORCID ID

Contact details

Universitätmedizin Mannheim
Klinik für Anästhesiologie und Operative Intensivmedizin
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 0.5ml vs. 1.0ml vs. 1.5ml hyperbaric prilocaine 2% for spinal saddle block in patients undergoing perianal surgery in an ambulatory setting

Acronym

Study hypothesis

In 2010 hyperbaric prilocaine 2% was introduced on the German market. There is no evidence based data about dosing of hyperbaric prilocaine 2% for perianal surgery. In this trial we compare the expansion of the saddle block according to three dosages of hyperbaric prilocaine 2%.

Ethics approval

Medical Ethics Committee II, Faculty of Medicine, Ruprecht Karl University of Heidelberg (Medizinische Ethikkommission II: MEdizinische Fakultät Mannheim der Ruprecht-Karls-Universität Heidelberg), approved on 21st September 2010 (ref: AZ.: 2010-303N-MA)

Study design

Randomised controlled single-centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Colorectal diseases

Intervention

Participants are randomised (1:1:1) to a dose of either 0.5ml or 1.0ml or 1.5ml of hyperbaric prilocaine 2%. The expansion of anaesthesia is tested with a toothpick and an ice-filled plastic tube.

Intervention type

Drug

Phase

Not Applicable

Drug names

Prilocaine 2%

Primary outcome measures

Expansion of anaesthesia tested with a toothpick and an ice-filled plastic tube. The expansion of anaesthesia is tested at two points of time:
1. After positioning of the patient for operation
2. Directly after the procedure has ended

Secondary outcome measures

1. Practicability
2. Postoperative analgetic consumption
3. Duration of stay in hospital

Overall trial start date

07/12/2010

Overall trial end date

07/07/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients (male/female) undergoing minor perianal surgery
2. Age: 18-80 years
3. American Society of Anesthesiologists (ASA) physical status I-III
4. No contraindications for spinal anaesthesia

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant exclusion criteria

1. Contraindications for spinal anaesthesia
2. Allergy to diclofenac

Recruitment start date

07/12/2010

Recruitment end date

07/07/2011

Locations

Countries of recruitment

Germany

Trial participating centre

Universitätmedizin Mannheim
Mannheim
68167
Germany

Sponsor information

Organisation

University Medical Centre Mannheim (Universitätsmedizin Mannheim) (Germany)

Sponsor details

Klinik für Anästhesiology und Operative Intensivmedizin
Theodor-Kutzer-Ufer 1-3
Mannheim
68167
Germany

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University Medical Centre Mannheim (Universitätsmedizin Mannheim) (Germany) - Department of Anaesthesiology and Intensive Care Medicine (Klinik für Anästhesiologie und Operative Intensivmedizin)

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

Publication citations

Additional files

Editorial Notes