Comparing the Analgesic Effects of Lidocaine Plus Buprenorphine and Lidocaine Alone In Women With Cesarean Section Under Spinal Anesthesia,Babol University of Medical Sciences
Aims: Evaluating the effect of Bupernorphine Lidocaine in comparison to Lidocaine alone in patients candidate for cesarean section to decrease the post-operation pain
Key criteria of inclusion and exclusion: Maternal or Fetal Contraindication for Spinal Anesthesia; Severe Fetus Distress; Emergency Cesarean; Addiction, Drug or OTC Abuse, Using Anti-epileptic Drugs, Blood Pressure More Than 140/90 mmHg, Gestational Diabetes,Psychiatric Problems; Uncontrolled Co-existent Internal Disease
Study population: All patients candidate for elective cesarean section in ASA class I aged 17-41 years
Sample size: 400
The intended intervention, time and primary outcome: Population randomly will divide into two groups: case group (Lidocaine and Bupernorphine) and control group (Lidocaine).They will be followed up to one week regards to the complications and effects after blind induction of intrathecal anesthesia by assistant of anesthesiology.
a same standard technique for spinal anesthesia induction. patient will be followed in ward or after discharge for about 1 week.
Data willl be coded and entered into computer by appropriate software and will analyze.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013022112552N1
Registration date:2013-06-07, 1392/03/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-06-07, 1392/03/17
Registrant information
Name
Ali Jabbari
Name of organization / entity
Babol University of Medical Sciences, Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1223 8296
Email address
anesth.jabbari@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Self Sponsored and Small Grant of Babol University of Medical Sciences. Some of The Drug and Equipment Will Be Provided By Hospitals Dependent on Babo University of Medical Sciences.
Expected recruitment start date
2013-04-04, 1392/01/15
Expected recruitment end date
2013-09-06, 1392/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Analgesic Effects of Lidocaine Plus Buprenorphine and Lidocaine Alone In Women With Cesarean Section Under Spinal Anesthesia,Babol University of Medical Sciences
Public title
Benefits of Using Intrathecal Buprenorphine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: All pregnant women candidate for elective cesarean section, in ASA class I (American Society of Anesthesiology) aged 17-41 Years.
Exclusion Criteria:
Maternal or fetal contraindication for spinal anesthesia; Severe fetus distress; Emergency Cesarean; Addiction, Drug or OTC abuse, Using Anti-epileptic drugs, Blood pressure more than 140/90 mmHg, Gestational diabetes,Psychiatric problems; Uncontrolled co-existent internal disease
Age
From 17 years old to 41 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
400
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Medicine, Babol Univercity of Medical Sciences
Street address
University Sq
City
Babol
Postal code
Approval date
2009-04-22, 1388/02/02
Ethics committee reference number
1115
2
Ethics committee
Name of ethics committee
Babol University of Medical Sciences
Street address
Babol University of Medical Sciences
City
Babol
Postal code
Approval date
2013-03-09, 1391/12/19
Ethics committee reference number
2159
Health conditions studied
1
Description of health condition studied
Post operative pain managment and adverse effect of intratechal buprenorphine
ICD-10 code
P04.0
ICD-10 code description
Reactions and Intoxications From Maternal Opiates and Tranquillizers Administered During Labour and Delivery
Primary outcomes
1
Description
Pain free period after operation
Timepoint
Pain assessment before, during and after surgery with Visual Analogue Score (VAS)
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
1
Description
Post Operative Nausea
Timepoint
Before anesthesia, 5 Min interval after spinal anesthesia, then every 6 hours in the ward
Method of measurement
Questionnaire
2
Description
Post Operative Vomitting
Timepoint
Before anesthesia, 5 Min interval after spinal anesthesia, then every 6 hours in the ward
Method of measurement
Questionnaire
3
Description
Hemodynamic Factors
Timepoint
Before anesthesia, 5 Min interval after spinal anesthesia, then every 6 hours in the ward
Method of measurement
Standard Manometer, Standard Therometer
Intervention groups
1
Description
In the Case group, 65-70 mg (1.3 to 1.4 cc) of 5% Lidocaine Plus 0.2 cc of Bupernorphine Will be Infused.
And in the Control Group, 65-70 mg (1.3-1.4 cc) of 5% Lidocaine Plus 0.2 cc of 0.9% Saline Normal Will Be Infused.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rohani Hospital
Full name of responsible person
Ali Jabbari
Street address
Department of Anesthesiology and Critical Care Medicine, Ayatollah Rohani Hospital
City
Babol
2
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Ebrahim Alijanpour
Street address
Department of Anesthesiology, Shahid Beheshti Hospital
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol Univesity of Medical Sciences
Full name of responsible person
ِDr.Alijanpour
Street address
Babol Univesity of Medical Sciences
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol Univesity of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Babol Univesity of Medical Sciences
Full name of responsible person
Ebrahim Alijanpour (Self Sponsored)
Street address
Department of Anesthesiology and Critical Care Medicine, Ayatollah Rohani Hospital
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol Univesity of Medical Sciences
Proportion provided by this source
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
Babol Univesity of Medical sciences, Golestan Univesity of Medical Sciences