Protocol summary

Summary
Recently most of laparoscopic surgeries especially gynecologic procedures are performed in an outpatient basis. Post operative pain is usually treated by opioids, which is expensive and may induce various side effects. Women experience moderate-to-severe pain on the first day after diagnostic laparoscopy. The aim of this study was to assess the efficacy of multimodal early premedication to prevent pain after laparoscopy. Following approval from the Local Ethics Committee and receipt of written informed consent, 90 ASA physical status I-II patients who underwent diagnostic laparoscopy will be randomly divided into two groups. General anesthesia will be standardized. The patients in group 1 will receive Paracetamol 1 g IV and intraperitoneal normal saline, 10 minutes before the end of operation. Group 2 will receive normal saline IV and intraperitoneal bupivacaine 0.25%, 40 ml with pethidine 50 mg, 10 minutes before the end of operation. The drugs will be prepared in covered syringes and will be injected blindly with an anesthesiologist who has performed anesthesia or with gynecologist(intraperitoneal drugs). Pain will be assessed and recorded by Visual Analogue Scale after arrival to the postanesthesia care unit and at 2, 4, 6, 8, 12 and 24 th hours postoperatively. Pethidine 0.5-1 mg/kg IV will be administered to the patient with VAS higher than 5. First analgesic request, total analgesia doses, and any other postoperative complications including nausea-vomiting and sedation also will be recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013072810765N4
Registration date: 2014-02-22, 1392/12/03
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-02-22, 1392/12/03
Registrant information
Name
Sousan Rasooli
Name of organization / entity
Alzahra hospital/Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
rasoolis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2014-02-20, 1392/12/01
Expected recruitment end date
2014-09-23, 1393/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of analgesic effect of intraperitoneal Bupivacaine-Petidine infiltration compared with intravenous after diagnostic gynecologic laparpscopy
Public title
Clinical trial of analgesic Effect of intraperitoneal bupivacaine-petidine infiltration compared with intravenous paracetamol on Post gynecologic diagnostic laparoscopic pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:Women with 20-38 years old; candidated for gynecologic diagnostic Laparoscopy; patients with ASA physical status I and II; patients who will give written informed consent Exclusion criteria: Women with ASA physical status III or higher;patients who received analgesic; patients who had contraindication for NSAIDs or Paracetamol like peptic ulcer; coagulopathy; renal failure;hepatic failure; allergy
Age
From 20 years old to 38 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice Chancellor for Reaserch, Tabriz University of Medical Sciences
Street address
Tabriz University of medical Sciences, Golgasht Ave, Tabriz
City
Tabriz
Postal code
Approval date
2013-11-27, 1392/09/06
Ethics committee reference number
92138

Health conditions studied

1

Description of health condition studied
Change in pain after laparoscopy
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Postoperative pain
Timepoint
2, 4, 6, 8, 12, 24 hours postoperative
Method of measurement
with the use of visual Analogue Scale

Secondary outcomes

1

Description
Sedation
Timepoint
2, 4, 6, 8, 12, 24 hours post operative
Method of measurement
with the use of modified Ramssy sedation scoring

Intervention groups

1

Description
The patients in group 1 will receive Paracetamol 1 g IV and normal saline intraperitoneal, 10 minutes before the end of operation
Category
Treatment - Drugs

2

Description
Group 2 will receive normal saline IV and intraperitoneal bupivacaine 0.25%, 40ml –pethidine 50 mg, 10 minutes before the end of operation.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Dr.Sousan Rasouli
Street address
South Artesh Ave, Alzahra Hospital, Tabriz, Iran
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Sousan Rasouli
Street address
South Artesh Ave, Alzahra Hospital, Tabriz, Iran
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
Alzahra Hospital
Full name of responsible person
Dr.Sousan Rasooli
Position
Associated Professor, Specialist in Anesthesiology
Other areas of specialty/work
Street address
Iran, Tabriz, Alzahra Hospital, south Artesh Ave
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
+98 41 1556 6449
Email
Rasooli_s@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Sousan Rasooli
Position
Associate Professor, Specialist in Anesthesiology
Other areas of specialty/work
Street address
Alzahra Hospital, South Artesh Ave, Tabriz,Iran
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
+98 41 1556 6449
Email
Rasooli_s@yahoo.com
Web page address

Person responsible for updating data

Contact

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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