Protocol summary

Summary
In current prospective randomized double-blinded clinical trial, 20 patients, candidate for shoulder surgery, with grade I or II of American society of anesthesiology (ASA), will be evaluated. Patients with history of uncontrollable chronic pain and pregnancy will be excluded. Subsequent to admission in recovery ward, patients will be randomly assigned to study groups and analgesia protocol will be administered. Right after preparation of required monitoring, pain score will be determined and recorded using pain severity scoring scale. Afterward, subsequent to pain onset in patients, analgesia will be provided via routine recovery (using morphine) in control group and using incremental and low dose remifentanil in intervention group. In control group, routine recovery will provided using 0.1 mg/kg morphine administration in divided doses. In intervetion group, diluted remifentanil solution including 10 micrograms per milliliter of remifentanil will be infused 1 milliliter per 20 seconds till pain relief. Individual recording the variables will be blinded to treatment type. Variables such as pain severity, analgesia onset time, analgesia duration, patient request to receive analgesics, apnea incidence, other adverse effects (including nausea and vomiting, bradycardia, hypotension, muscle spasm, pruritus), pain recurrence time and amount of administered drugs will be recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017050126328N4
Registration date: 2017-06-06, 1396/03/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-06-06, 1396/03/16
Registrant information
Name
Masoud Parish
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3385 5842
Email address
parishm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz university of medical sciences,
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial on incremental and low dose remifentanil effect on acute postoperative pain in recovery room after shoulder surgeries
Public title
Remifentanil effect on shoulder surgery postoperative pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients candidate to undergo shoulder surgery; aged between 20 and 60 years old; Class I or II according to ASA classification. Exclusion criteria: history of uncontrollable chronic pain; history of allergy to analgesics; history of psychotropic drugs consumption; recent use of analgesics; operation time more than 2 hours; pregnant and breastfeeding women.
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization will be performed using Randlist 1.2. software.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Vice chancellor for research, Tabriz university of medical sceinces, Daneshgah square
City
Tabriz
Postal code
Approval date
2016-08-29, 1395/06/08
Ethics committee reference number
IR.TBZMED.REC.1395.665

Health conditions studied

1

Description of health condition studied
Shoulder fracture postoperative pain
ICD-10 code
S43
ICD-10 code description
Dislocation, sprain and strain of joints and ligaments of shoulder girdle

Primary outcomes

1

Description
Duration of analegsia onset
Timepoint
Postoperative recovery
Method of measurement
Questionnaire

2

Description
Patients pain severity after shoulder surgery during recovery
Timepoint
In admission to recovery room and discharge from the recovery
Method of measurement
Using visual analogue scale

Secondary outcomes

1

Description
administered remifentanil dosage amount
Timepoint
During admission to recovery
Method of measurement
Questionnaire

2

Description
nausea and vomiting due to remifentanil injection
Timepoint
During admission to recovery
Method of measurement
Questionnaire

3

Description
hypotension due to remifentanil injection
Timepoint
During admission to recovery
Method of measurement
Questionnaire

4

Description
bradycardia due to remifentanil injection
Timepoint
During admission to recovery
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group: Diluted remifentanil solution including 10 micrograms per milliliter will be infused 1 milliliter each 20 minutes, till complete analgesia onset.
Category
Treatment - Drugs

2

Description
Control group: 0.1 milligram per kilogram morphine will be administered in divided doses, till complete analgesia onset.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohada Hospital
Full name of responsible person
Dr. Masoud Parish
Street address
Shohada hospital, Golshahr street, Yaxchian, Tabriz, Iran
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostadrahimi
Street address
Vice chancellor for research, Tabriz University of medical sceinces, Daneshgah square
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Masoud Parish
Position
Associate Professor, Specialist in Anesthesiology
Other areas of specialty/work
Street address
Shohada hospital, Golshahr street, Yaxchian, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 3385 5842
Fax
Email
parsihm@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Masoud Parish
Position
Associate Professor, Specialist in anesthesiology
Other areas of specialty/work
Street address
Shohada hospital, Golshahr street, Yaxchian, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 3385 5842
Fax
Email
parishm@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Masoud Parish
Position
Associate Professor, Specialist in Anesthesiology
Other areas of specialty/work
Street address
Shohada hospital, Golshahr street, Yaxchian, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 3385 5842
Fax
Email
parishm@tbzmed.ac.ir
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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