Protocol summary

Summary
Objectives:The aim of the study is, assessment of sciatic nerve press for acute post operative pain control in middle ear surgery. In order to evaluation of this effect we prepared a proposal to study this effect for post operative pain management. Design: 100 patients with Tympanoplasty were included. Inclusion criteria was: 20- 60 ages with ASA class I-II and exclusion criteria: Addcition; Psychopathic disorder; Patient avoidance; previous painful disease and problem on prone positioning. One hour after full recovery and awareness primary pain intensity were measured and recorded by VAS scale. Patients were randomized in to two equal groups (Table of random numbers). Intervention group switched to prone position and according to the size of patients sciatic nerve pressed applied by 11-20 Kg parallel on both posterior part of thigh, for 2 minutes. Then patient turn to rest and supine position and pain score measured every 2hour until 8 hour. If VAS scales elevated more than 4, intravenous Paracetamole infusion started for pain relief and total 8 hour need calculated and recorded. In sham group after prone positioning, technician put his hands over the sciatic nerve parallel on both posterior part of thigh without any pressure (placebo effect). Anesthesia and other medication were similar in both groups. If patients need more Paractamol for pain relief (pain scores over 4) they got additional dose of Paracetamol. This process was repeated every 2 hour until 6 hours for each group. Outcome: finally pain intensity and analgesic consumption in both group Calculated then compared

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201504051772N18
Registration date: 2015-10-24, 1394/08/02
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-10-24, 1394/08/02
Registrant information
Name
Dawood Aghamohammadi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1381 8940
Email address
aghamohammadid@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Faculty of Medicine,Tabriz University of Medical Sciences
Expected recruitment start date
2014-11-21, 1393/08/30
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of sciatic nerve press for acute post operative pain control in middle ear surgery
Public title
Assessment of sciatic nerve press for acute post operative pain control in middle ear surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age: 20-60 ; ASA - ll Exclusion criteria: Addiction; psychopathic; patient avoidance; previous painful disorders; problem on pron positioning
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences University of Medical Sciences
Street address
Vice Chancellor for Research-Tabriz University of Medical Sciencest- Daneshghah Street Tabriz East Azarbaijan
City
Tabriz
Postal code
Approval date
2013-11-18, 1392/08/27
Ethics committee reference number
344/94

Health conditions studied

1

Description of health condition studied
post operative pain
ICD-10 code
R52.0
ICD-10 code description
Acute pain

Primary outcomes

1

Description
pain
Timepoint
0-1-2-3-4-5-6-7-8 time of mesurments
Method of measurement
Visual Analogue Scale

Secondary outcomes

1

Description
Intravenous Paracetamol as an analgesic consumption
Timepoint
0-1-2-3-4-5-6-7-8 time of mesurments
Method of measurement
Intravenous Paracetamol Dose

Intervention groups

1

Description
Applying pressure on sciatic nerve
Category
Prevention

2

Description
Without applying pressure on sciatic nerve
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital/Tabriz
Full name of responsible person
Dawood Aghamohammadi
Street address
Daneshghah street, Imam Reza Hospital
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Faculty of Medicine,Tabriz University of Medical Sciences
Full name of responsible person
Hassan Soleimanpour
Street address
Vice Chancellor for Research-Tabriz University of Medical Sciencest- Daneshghah Street Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Faculty of Medicine,Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Anesthesiology Dept, Faculty of Medicine, Tabriz University of Medical Science
Full name of responsible person
Dawood Aghamohammadi
Position
Associate Professor
Other areas of specialty/work
Street address
Anesthesiology Dept, Faculty of Medicine, Tabriz University of Medical Science Tabriz
City
Tabriz
Postal code
Phone
+98 41 3381 8940
Fax
Email
aghamohammadid@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Anesthesiology Dept, Faculty of Medicine, Tabriz University of Medical Science
Full name of responsible person
Dawood Aghamohammadi
Position
Associate Professor
Other areas of specialty/work
Street address
Anesthesiology Dept, Faculty of Medicine, Tabriz University of Medical Science Tabriz
City
Tabriz
Postal code
Phone
+98 41 3381 8940
Fax
Email
aghamohammadid@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Anesthesiology Dept, Faculty of Medicine, Tabriz University of Medical Science
Full name of responsible person
Dawood Aghamohammadi
Position
Associate Professor
Other areas of specialty/work
Street address
Anesthesiology Dept, Faculty of Medicine, Tabriz University of Medical Science Tabriz
City
Tabriz
Postal code
Phone
+98 41 3381 8940
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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