The purpose of this randomized double blind clinical trial is to compare the effect of interpleural morphine analgesia with traditional intravenous morphine administration on pain and supplemental analgesic usage after VATS. Forty American Society of Anesthesiologists class I and II scheduled for VATS are randomly assigned to two equal groups for postoperative pain management. At the completion of operation, a catheter was placed in the pleural space under direct vision. At the end of VATS, eligible patients in intervention group will receive a single bolus of 0.1 mg/kg of morphine interpleurally. The patients in the control group will receive a single bolus of 0.1 mg/kg of morphine, intravenously. During the first postoperative 8 hours, pain score at the rest and on coughing, supplemental analgesic requirements, mean arterial pressure, heart rate, SPO2, degree of sedation, and side effects will be monitored every hour.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107046942N1
Registration date:2011-07-21, 1390/04/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-07-21, 1390/04/30
Registrant information
Name
Shideh Dabir
Name of organization / entity
NRITLD, Masih Daneshvari Hospital, Shahid Beheshti University of Medical Sciences.
Country
Iran (Islamic Republic of)
Phone
+98 21 2610 9644
Email address
sdabir@nritld.ac.ir
Recruitment status
Recruitment complete
Funding source
National Research Institute of Tuberculosis & Lung diseases
Expected recruitment start date
2010-10-23, 1389/08/01
Expected recruitment end date
2011-10-22, 1390/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of interpleural versus intravenous morphine for pain relief after video-assisted thoracoscopic Surgery
Public title
The effect of interpleural and intravenous morphine on pain after video-assisted thoracoscopic surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ASA Class 1& 2, Age more than or equal 18, Weight more than or equal 40 kg, no limitations in terms of sex, height, surgery duration, type of surgical procedure, number and location of chest tubes.
Exclusion criteria: Opium/alcohol addiction, drug abuse, mental retardation, psychological disorders, severe pleural adhesions and fibrosis, bronchopleural fistula, severe empyema, ASA class more than or equal 3, opioid consumption prior to surgery, inability to clamp chest tubes after surgery
Age
From 18 years old to 70 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Research Institute of Tuberculosis & Lung Disease
Street address
Masih Daneshvari Hospital, Darabad, Niavaran
City
Tehran
Postal code
1955841452
Approval date
2004-11-20, 1383/08/30
Ethics committee reference number
p/25/29/5236
Health conditions studied
1
Description of health condition studied
Two different analgesic methods after VATS
ICD-10 code
Y90, Y91,
ICD-10 code description
Supplementary factors related to causes of morbidity and mortality classified elsewhere
Primary outcomes
1
Description
Pain severity after VATS
Timepoint
every one hour during the first postoperative 8 hours