Purpose: Comparison of shoulder pain after injection of Intrapleural Bupivacaine with Intraperitoneal Bupivacaine after laparoscopic cholecystectomy surgery. Design and criteria: This study is prospective, randomized, double blinded and clinical trial. 60 patients candidate for laparoscopic cholecystectomy surgery were chosen and divided randomly to 3 same groups. Inclusion criteria: Candidate for elective laparoscopic cholecystectomy; age over 18 years; ASA I-II; no history of lung disease; no history of motion sickness; no record of Addiction; no history of choledocholithiasis , Exclusion criteria: require open cholecystectomy; complicate surgery; incidence of adverse events intraoperative. Methods and intervention: we compared 3 group in this study group 1 without local anesthetic, group two 30cc marcaine 0.25% intrapleural, and group three 30 cc marcaine 0.25% intraperitoneal. Primary and secondary outcome: after surgery, the incidence of shoulder pain with VAS, in recovery room, 6 , 12 and 24 hours later and Paracetamol consumption and Diclofenac suppository dosage 24 hours after laparoscopic cholecystectomy surgery are evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013072712094N3
Registration date:2013-08-30, 1392/06/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-08-30, 1392/06/08
Registrant information
Name
Majid Razavi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 915 110 8630
Email address
razavim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mashhad University of Medical Science
Expected recruitment start date
2013-08-11, 1392/05/20
Expected recruitment end date
2013-10-12, 1392/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of shoulder pain after injection of Intrapleural Bupivacaine with Intraperitoneal Bupivacaine after laparoscopic cholecystectomy surgery
Public title
Shoulder pain after laparoscopy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Candidate for elective laparoscopic cholecystectomy; age over 18 years; ASA I-II; no history of lung disease;no history of motion sickness; no record of Addiction; no history of choledocholithiasis
Exclusion criteria: require open cholecystectomy; complicate surgery; incidence of adverse events intraoperative
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not 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 Mashhad University of Medical Sciences
Street address
Ghoreishi apartment, Daneshgah st, Mashhad
City
Mashhad
Postal code
Approval date
2013-06-08, 1392/03/18
Ethics committee reference number
910637
Health conditions studied
1
Description of health condition studied
cholecystectomic laparascopic
ICD-10 code
K80.1
ICD-10 code description
Calculus of gallbladder with other cholecystitis
Primary outcomes
1
Description
shoulder pain
Timepoint
recovery room to 24 hours later
Method of measurement
Verbal analog scale(VAS)
Secondary outcomes
1
Description
Diclofenac suppository dosage
Timepoint
24 hours after surgery
Method of measurement
mili gram
2
Description
Paracetamol consumption
Timepoint
24 hours after surgery
Method of measurement
mili gram
Intervention groups
1
Description
intervention group 2 : intrapleural 30 ml of marcaine 0.25%
Category
Treatment - Drugs
2
Description
control group: not injection
Category
Treatment - Drugs
3
Description
intervention group 1 : intraperitoneal 30 ml of marcaine 0.25%
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Majid Razavi
Street address
Department of Anesthesiology, Imam Reza Hospital, Ibne Sina st, Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Science
Full name of responsible person
Mohsen Tafaghodi
Street address
Ghoreishi apartment, Daneshgah street, Mashhad
City
Mashhad
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, Mashhad University of Medical Science
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
Mashhad University of Medical Sciences
Full name of responsible person
Majid Razavi
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Anesthesia, Imam Reza Hospital, Ibne Sina st, Mashhad
City
Mashhad
Postal code
Phone
+98 51 1852 5209
Fax
Email
razavim@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University Of Medical Sciences
Full name of responsible person
Majid Razavi
Position
Assistan Professor
Other areas of specialty/work
Street address
Deparment of Anestesia, Imam Reza Hospital, Ibne Sina st, Mashhad
City
Mashhad
Postal code
Phone
+98 51 1852 5209
Fax
Email
razavim@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Razavi
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Anesthesia, Imam Reza Hospital, Ibne Sina Street, Mashhad
City
Mashhad
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)