The effectiveness of intraperitoneal normal saline infusion and the pulmonary recruitment maneuver to reduce postlaparoscopic shoulder and upper abdominal pain in elective gynecologic surgeries
The study was designed as a randomized, controlled, clinical trial to estimate the effectiveness of pulmonary recruitment maneuver and intraperitoneal normal saline infusion on reducting postlaparoscopic shoulder and upper abdominal pain and surgical pain. A total of 280 patients scheduled for elective laparoscopic surgeries were randomly divided in four groups: pulmonary recruitment maneuver, intraperitoneal normal saline infusion, combination of pulmonary recruitment maneuver and intraperitoneal normal saline infusion, and control group with no intervention. The primary endpoint of this study was postlaparoscopic upper abdominal pain, shoulder pain and surgical pain as measured by a visual analogue scale (VAS).Visual analogue scale ratings were obtained at recovery, 2, 6,12 and 24 hours postoperatively. secondary outcome measures included the occurrence of nausea or vomiting and abdominal distention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201402022576N8
Registration date:2014-05-05, 1393/02/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-05-05, 1393/02/15
Registrant information
Name
Fatemeh Davari Tanha
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8831 3955
Email address
fdavaritanha@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-04-01, 1393/01/12
Expected recruitment end date
2015-03-31, 1394/01/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of intraperitoneal normal saline infusion and the pulmonary recruitment maneuver to reduce postlaparoscopic shoulder and upper abdominal pain in elective gynecologic surgeries
Public title
The effectiveness of intraperitoneal normal saline infusion and the pulmonary recruitment maneuver to reduce postlaparoscopic shoulder and upper abdominal pain in elective gynecologic surgeries
Purpose
Prevention
Inclusion/Exclusion criteria
The patients selected for screening were all required laparoscopic surgery during the study period. The inclusion criteria were female gender, age 20–65 years old; an American Society of Anesthesiologists physical status classification of I or II, and a willing to undergo laparoscopic surgeries for benign gynecologic lesions, including laparoscopically assisted vaginal hysterectomy, myomectomy, and cystectomy. Patients were excluded from randomization if their disease was malignant, or if they were unwilling to participate.
Age
From 20 years old to 65 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
280
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The etic commitee of Tehran university of medical sciences
Street address
Faculty of medicine-Ebnesina avenue-Keshavarz street-
City
Tehran
Postal code
Approval date
2014-02-04, 1392/11/15
Ethics committee reference number
9111290011
Health conditions studied
1
Description of health condition studied
Laparoscopy
ICD-10 code
N99
ICD-10 code description
Postprocedural disorders of genitourinary system, not elsewhere classified
Primary outcomes
1
Description
Post operative pain
Timepoint
2, 4, 6, 12, 24 hours after surgery
Method of measurement
VAS analouge
Secondary outcomes
1
Description
Nausea
Timepoint
24 hours after surgery
Method of measurement
Questionaire
2
Description
Vomiting
Timepoint
24 hours after surgery
Method of measurement
Questionaire
3
Description
Abdominal distention
Timepoint
24 hours after surgery
Method of measurement
Questionaire
Intervention groups
1
Description
Intervention1: pulmonary recruittment manuver,deep respiration by anesthesiologist is done at the end of surgery
Category
Prevention
2
Description
Intervention2:intraperitoneal normal salin ,150ml in upper abdomen is left