The aim of this study was to check the efficacy of this method for analgesia in a postoperative lumbar microdiscectomy. In this randomized clinical trial, a total of 100 patients with low back radicular pain who underwent microdiscectomy were included into two equal groups. The patients in the intervention group received direct morphine (2mg/5mL) spillage while in the control group received normal saline (5mL) spillage as a placebo. The main outcome measured were pain intensity in recovery room and the ward, amount of analgesics used, postoperative ambulation time, post-operative hospitalization stay.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201101161772N5
Registration date:2011-04-11, 1390/01/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-04-11, 1390/01/22
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
Tabriz University of Medical Sciences
Expected recruitment start date
2009-08-23, 1388/06/01
Expected recruitment end date
2010-08-23, 1389/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of epidural morphine in controlling post-operative pain after microdiscectomy
Public title
Epidural Morphine for post operative pain control
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: ASA I-II, age 25-65 years old, Microdiscectomy in one level
Exclusion criteria: Addiction, Psychosis, depression, history of chronic pain
Age
From 25 years old to 65 years old
Gender
Both
Phase
N/A
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
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Vice chancellor for research, Faculty of Medicine, Daneshgah Street
City
Tabriz
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
5/4/9283
Health conditions studied
1
Description of health condition studied
lumbar discopathy
ICD-10 code
M51.1+
ICD-10 code description
Lumbar and other intervertebral disc disorders with radiculopathy
Primary outcomes
1
Description
pain
Timepoint
6, 12, 18, and 24 hours after operation
Method of measurement
without pain- mild pain- moderate pain- severe pain
Secondary outcomes
1
Description
Rate of morphine consumption
Timepoint
24 hours after the operation
Method of measurement
milligrams
2
Description
hospital stay
Timepoint
During hospital stay
Method of measurement
In days
3
Description
ambulation time
Timepoint
During hospital stay
Method of measurement
number of days from operation until ambulation
Intervention groups
1
Description
Sprinkling 5 ml (2 mg) morphine to the epidural space before closing surgery site
Category
Treatment - Drugs
2
Description
Sprinkling 5 ml saline to the epidural space before closing surgery site
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Educational Center of Shohada Hospital
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dawood Aghamohammadi
Street address
Research Group of Anesthesiology Department, Faculty of Medicine, Tabriz University of Medical Sciences, Daneshgah 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
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
Dawood Aghamohammadi
Full name of responsible person
Dawood Aghamohammadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Research Group of Anesthesiology Department, Faculty of Medicine, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz
City
Tabriz
Postal code
Phone
+98 914 115 0785
Fax
Email
aghamohammadid@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
Dawood Aghamohammadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Assistant professor
City
Research Group of Anesthesiology Department, Faculty of Medicine, Tabriz University of Medical Scien
Postal code
Phone
+98 41 1334 1994
Fax
Email
aghamohammadid@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Medicine, Tabriz University of Medical Sciences
Full name of responsible person
Dawood Aghamohammadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Research Group of Anesthesiology Department, Faculty of Medicine, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1334 1994
Fax
Email
daghamohamadi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)