1. Home
  2. Approved trials
  3. » فارسی

The opioid sparing effect of adding ultra-low doses of naloxone to bupivacaine% 0/25 with or without sufentanil in Transverse Abdominis Plane Block on patients after elective caesarean section ;double- blind, randomized , clinical trial

Protocol summary

Summary
Transverse abdominis plane block is considered as a method of postoperative pain control in abdominal surgeries. To avoid systemic side effects of analgesics and to reduce the opioid consumption postoperatively we performed TAP block on ceasarean section patients. In this double blind randomised clinical trial ,164 patients candidates for cesarean section, aged between 20-40 ,with ASA Class I,II were randomly assigned to recieve TAP block,in Shariati Hospital during years 2012-2013. After obtaining written consent patients allocated in 4 groups of 41 randomly. After last stitch ,bilateral TAP block was performed under ultrasonographic guide.control group patients recieved 18 ml bupivacaine 0.25% along with 2 cc normal saline on each side, Sufentanil group (S) recieved 18ml bupivaciane 0.25% along with 1ml normal saline and 1ml sufentanil(5micgr)on each side. The Naloxone group (N) recieved 18 ml bupivacaine 0.25% along with 100 (ngr) naloxone (1ml)and 1ml normal saline on each side, and Naloxone and sufentanil group (N+S) recieved 18 ml bupivaciane 0.25% along with sufentanil 1ml(5microgr) and 100 ng naloxone on each side. In the recovery room, pain intensity was measured at baseline then 2h, 6h, 12h, 24h postoperatively using visual analoge scale and the time of first request for analgesic and opioid consumption during 24 h postoperation also wrer recorded . The primary goal was to evaluate the morphine consumption to relief postoperative pain.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2013041212958N2
Registration date: 2013-06-07, 1392/03/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-06-07, 1392/03/17
Registrant information
Name
Yassaman Aghajani
Name of organization / entity
Tehran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2373
Email address
y-aghajani@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-01-01, 1390/10/11
Expected recruitment end date
2013-02-01, 1391/11/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The opioid sparing effect of adding ultra-low doses of naloxone to bupivacaine% 0/25 with or without sufentanil in Transverse Abdominis Plane Block on patients after elective caesarean section ;double- blind, randomized , clinical trial
Public title
The effect of ultra-low dose of naloxone on analgesia after abdominal wall nerves block in patients after cesarean section
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria: age 20-40; ASA class I,II; primigravid; non addict; without history of allergy to protocol drugs Excluxion criteria: patients whom recieved drugs other than the ones mentioned in protocol in 24 h preoperation; surgery duration more than 90 minutes
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 164
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
Ethics Committee, Faculty of Medicine
Street address
Faculty of Medicine, Tehran University of Medical Sciences and Health Care
City
Tehran
Postal code
-
Approval date
2012-09-26, 1391/07/05
Ethics committee reference number
91/ د/130/1409

Health conditions studied

1

Description of health condition studied
pain
ICD-10 code
R52.0
ICD-10 code description
acute pain

Primary outcomes

1

Description
Pain intesity
Timepoint
recovery room,2,6,12,24 h after surgery
Method of measurement
visual analoge scale

2

Description
Morphine consumption
Timepoint
recovery room, 2,6,12,24h after surgery
Method of measurement
opioid registration by milligram

Secondary outcomes

1

Description
Sensory Block Duration
Timepoint
24h
Method of measurement
Pinprick test

Intervention groups

1

Description
under guidence of ultrasonography Transverse abdominis Block performed bilateraly in control group "patients recieved 18 ml bupivacaine 0.25% along with 2 cc normal saline on each sideIn the recovery room, pain intensity was measured at baseline then 2h, 6h, 12h, 24h postoperatively using visual analoge scale and the time of first request for analgesic and opioid consumption during 24 h postoperation also wrer recorded .
Category
Treatment - Drugs

2

Description
under guidence of ultrasonography Transverse abdominis Block performed bilateraly in sufentanil group patients recieved 18 ml bupivacaine 0.25% along with 1 cc normal saline and 1 ml sufentanil (5 microgram) on each sideIn the recovery room, pain intensity was measured at baseline then 2h, 6h, 12h, 24h postoperatively using visual analoge scale and the time of first request for analgesic and opioid consumption during 24 h postoperation also wrer recorded
Category
Treatment - Drugs

3

Description
under guidence of ultrasonography Transverse abdominis Block performed bilateraly in naloxone and sufentanil group patients recieved 18 ml bupivacaine 0.25% along with 1 cc naloxone (100 nanogram) alon with 5 microgram sufentanil on each side In the recovery room, pain intensity was measured at baseline then 2h, 6h, 12h, 24h postoperatively using visual analoge scale and the time of first request for analgesic and opioid consumption during 24 h postoperation also wrer recorded
Category
Treatment - Drugs

4

Description
under guidence of ultrasonography Transverse abdominis Block performed bilateraly in Naloxone group patients recieved 18 ml bupivacaine 0.25% along with 1 cc normal saline alon with 100 nanogram (1 ml) Naloxone on each side In the recovery room, pain intensity was measured at baseline then 2h, 6h, 12h, 24h postoperatively using visual analoge scale and the time of first request for analgesic and opioid consumption during 24 h postoperation also wrer recorded
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr.Ali Shariati hospital
Full name of responsible person
Samira Sorbi
Street address
Dr.Ali Shariati hospital, North Karegar St.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhoundzade
Street address
Tehran University of Medical Sciences
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Samira Sorbi
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Dr.Ali Shariati Hospital, North Karegar St.
City
Tehran
Postal code
-
Phone
+98 21 8490 2373
Fax
-
Email
khatere80@yahoo.com
Web page address
-

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Movafegh
Position
Professor
Other areas of specialty/work
Street address
Dr.Ali Shariati, North Karegar St.
City
Tehran
Postal code
-
Phone
+98 21 8490 2397
Fax
-
Email
movafegh@sina.tums.ac.ir
Web page address
-

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Samira Sorbi
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Dr.Ali Shariati, North Karegar St.
City
Tehran
Postal code
-
Phone
+98 21 8490 2373
Fax
-
Email
-
Web page address
-

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
Loading...