Protocol summary

Summary
Laparoscopic cholecystectomy is the treatment of choice for symptomatic cholelithiasis, laparoscopic cholecystectomy result in less post-operative pain compared with open cholecystectomy, post-operative pain after laparoscopic cholecystectomy remain an issue ,pain can prolong hospital stay and lead to increased morbidity; the type of pain after laparoscopy differs from that observed after laparotomy, patients complain more of visceral pain after laparoscopy. Shoulder pain secondary to diaphragmatic as a result if CO2 pneumoperitoneum after laparoscopy surgery. Pain after laparoscopy may be moderate or even severe for some patients and may require opioid treatment. Although opioid have played a prominent role in reduce of post-operative pain, but the side effect such as ilius and vomiting and nausea may limit their future use in some patients. Several authors have reported a substantial decrease in post-operative pain after laparoscopic cholecystectomy with the use of intra peritoneal local anesthesia. The aim of this study is to compare the lidocaine and bupivacain with normal saline on reduce pain and vomiting and nausea after cholecystectomy laparoscopic. Material and methods: A total of 168 patients undergoing laparascopic cholecystectomy were randomly assigned to three groups (Group A, Group B, and Group C). On the completion of cholecystectomy, 20 mL of lidocaine 1% was infused intraperitoneally in Group B, 20 mL of Bupivacain 0.25% was infused intraperitoneal in Group C, and 20 mL of normal saline was infused intraperitoneally in Group A. The incidence and severity of PONV, the pain score, and the rescue analgesics were assessed 0 min, 15 min, 30 min, 1 h, 2 h, 6 h, 12 h, and 24 h after surgery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014020716516N1
Registration date: 2014-08-12, 1393/05/21
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-08-12, 1393/05/21
Registrant information
Name
Sadeghe Nadri
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 3322 3004
Email address
dr.s.nadri@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Lorestan University of Medical Sciences
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2014-09-21, 1393/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of intraperitoneal lidocaineand bupivacain on post operative pain in laparoscopic cholecystectomy compare with normal saline in patient who are undergoing laparoscopic cholecystectomy .
Public title
the effect of intraperitoneal lidocaineand bupivacain on post operative pain in laparoscopic cholecystectomy compare with normal saline in patient who are undergoing laparoscopic cholecystectomy .
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients that are candidate foe elective laparoscopic cholecystectomy; age between 20-70 years old. Exclusion criteria: the patients that have heart disease and hypertension and diabetes mellitus and chronic respiratory diseases.
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 168
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
khoramabad medicein university
Street address
khoramabad kilometer30 road khoramabad-boroujerd
City
khoramabad
Postal code
www.lums.ac.ir
Approval date
2012-10-27, 1391/08/06
Ethics committee reference number
200,76316

Health conditions studied

1

Description of health condition studied
Chronic cholecystitis
ICD-10 code
K81.1
ICD-10 code description
Chronic cholecystitis

Primary outcomes

1

Description
Pain
Timepoint
24 hours after surgery
Method of measurement
VAS score system

Secondary outcomes

1

Description
Nausea and vomiting
Timepoint
Questionnaire
Method of measurement
24 hours after surgery

2

Description
Blood pressure
Timepoint
Blood pressure measuring device
Method of measurement
24 hours after surgery

3

Description
Pulse rate
Timepoint
24 hours after surgery
Method of measurement
Pulse oximertry

Intervention groups

1

Description
20 mL of lidocaine 1% was infused , and 20 mL of normal saline was infused intraperitoneally in Group A.
Category
Treatment - Drugs

2

Description
20 mL of lidocaine 1% was infused intraperitoneally in Group B,
Category
Treatment - Drugs

3

Description
20 mL of Bupivacain 0.25% was infused intraperitoneally in Group C
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohada Ashyer hospital
Full name of responsible person
dr. Ssedighe Nadri
Street address
Enghelab street
City
Khoramabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Dr. Sedigheh Nadri
Street address
3 kilometer road khoramabad-boroujerd
City
Khoramabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Lorestan 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
Lorestan University of Medical Sciences
Full name of responsible person
Dr. Sedigheh Nadri
Position
Physician Anesthesiologist
Other areas of specialty/work
Street address
Shohada Ashayer hospital-khoramabad
City
khoramabad
Postal code
Phone
+98 66 1323 6402
Fax
+98 66 1323 6402
Email
dr.s.nadri@lums.ac.ir
Web page address
www.lums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Dr. Sedigheh Nadri
Position
Physician Anesthesiologist
Other areas of specialty/work
Street address
Shoda Ashayer hospital- khoramabad
City
Khoramabad
Postal code
Phone
+98 66 1323 6402
Fax
Email
dr.s.nadri@lums.ac.ir
Web page address
www.lums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Dr. Sedighe Nadri
Position
Physician Anesthesiologist
Other areas of specialty/work
Street address
Shoda Ashayer hospital-khoramabad
City
Khoramabad
Postal code
Phone
+98 66 1323 6402
Fax
Email
dr.s.nadri@lums.ac.ir
Web page address
www.lums.ac.ir

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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