(1) Introduction and background: Cesarean is one of the most common gynecologic operations and spinal anesthesia is considered as one of the usual anesthesia methods in such operations. Lidocaine might lead to complications such as nausea, vomiting, hypotension, bradycardia and etc… Using an appropriate combination of Lidocaine and Sufentanil might be very significant for its possible effect in reducing these complications and Inducing an appropriate post-operative analgesia and desired spinal level. Considering the great number of such patients, studying this combination is very significant. (2) Objectives: In the present research, attempt will be made to achieve the appropriate minimal dose of Licocaine which will likely bring about the optimum analgesia level and minimal side effects for the patients. (3) Design: Randomized Controlled Trial (4) Setting and conduct: Study conduct on patients admitted for Cesarean section in Imam Reza (AS) Hospital in Kermanshah City, Iran. (5) Participants including major eligibility criteria: The subjects were seventy patients in ASA class I & II, candidate for Cesarean. Following their informed consent, they were randomly assigned into three groups. In all patients fixed doses of Sufentanil and Epinephrine and different doses of Lidocaine were used. Spinal anesthesia was then induced in sitting position using whitecare needle at lumbar four– lumbar five interspaces. (6) Intervention: The intervention A group will be received Intrathecal injection of seventy five milligram lidocaine plus two point five micro gram sufentanil (forty two patients). The intervention B group will be received Intrathecal injection of sixty milligram lidocaine plus two point five µg sufentanil (forty two patients). The intervention C group will be received Intrathecal injection of fifty milligram lidocaine plus two point five micro gram sufentanil (forty two patients). (7) Main outcome measures (variables): The Severity of pain, nausea and vomiting in post operative period will be measured by Visual analogue Scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201102071310N7
Registration date:2011-02-24, 1389/12/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-02-24, 1389/12/05
Registrant information
Name
Alireza Ahmadi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3428 2670
Email address
info-jivr@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Science,
Expected recruitment start date
2008-08-22, 1387/06/01
Expected recruitment end date
2010-08-23, 1389/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized trial to determination of minimal dose of Lidocaine with Sufentanil‘s fixed dose in spinal anesthesia for cesarean section.
Public title
Determination of minimal dose of Lidocaine with Sufentanil‘s fixed dose in spinal anesthesia for cesarean section.
Purpose
Treatment
Inclusion/Exclusion criteria
Exclusion criteria: All patients who are not class I and II ASA; Patients not signed the informed consent; Patients with underlying disease; Patients with chronic pain or; Who have used analgesic medications in the past forty eight hours; Patients with abscess or local infection at the injection site; Severe agitation; Cerebral disorder; Severe psychological disorders and addiction;
Age
From 20 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Science
Street address
Shahid Beheshti Boulevard, Kermanshah,
City
Kermanshah
Postal code
67188
Approval date
2009-11-24, 1388/09/03
Ethics committee reference number
674
Health conditions studied
1
Description of health condition studied
Delivery by elective caesarean section
ICD-10 code
O82.0
ICD-10 code description
Delivery by elective caesarean section
Primary outcomes
1
Description
Severity of pain
Timepoint
every three minute after procedure.
Method of measurement
Visual analogue Scale.
2
Description
Nausea and Vomiting
Timepoint
Two and twenty four hours postoperative
Method of measurement
have, or not have
Secondary outcomes
1
Description
Blood Pressure
Timepoint
Once before spinal then every three minute after procedure with Datascope, Model: Pse-420
Method of measurement
mm Hg
2
Description
Heart Rate
Timepoint
Once before spinal then every three minute after procedure with Datascope model: Pse-420
Method of measurement
Number per minute
Intervention groups
1
Description
Intrathecal injection of 75mg lidocaine+ 2.5 µg sufentanil in group A(42 patients).
Category
Treatment - Drugs
2
Description
Intrathecal injection of 60mg lidocaine+2.5 µg sufentanil in group B(42 patients).
Category
Treatment - Drugs
3
Description
Intrathecal injection of 50mg lidocaine+2.5µg sufentanil in group C(42 patients).