Low Dose Spinal Anesthesia in Cesarean Surgery

Study Overview
=================
Brief Summary
-----------------
Anesthesia for cesarean section requires special importance because it may affect both mother and the baby. To avoid maternal hypotension related to spinal anesthesia must be the primary objective during anesthesia. Even though many factors influence sensory nerve block for surgical anesthesia, local anesthetic dose is the main determinant. Another factor that influence the sensory nerve block is the obesity related to pregnancy. Due to the enlargement of epidural venous plexus related to pregnancy, the subarachnoid and epidural space reduces, so the local anesthetic requirement also reduces. Many investigators recommend lower dose of local anesthetic in obese patients due to reduced requirement There are many studies about dose regimens for cesarean anesthesia, but ideal dose have not been found. Investigators have designed this study to see the effects of conventional dose (10 mg bupivacaine) vs. low dose plus fentanyl (7,5 mg bupivacaine+25 mcg fentanyl) in obese and normal weight pregnant for cesarean section. The hypothesis was: the low dose regimen provides surgical anesthesia in obese patients while avoiding maternal hypotension.

Official Title
-----------------
Does the Reduction of Local Anesthetic Dose Provide Surgical Anesthesia While Avoiding Maternal Hypotension in Obese Pregnant for C/S by Single Shot Spinal Anesthesia?

Conditions
-----------------
Maternal Hypotension, Anesthesia

Intervention / Treatment
-----------------
* Drug: Bupivacaine
* Drug: Fentanyl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant patients Exclusion Criteria: Spinal anesthesia contraindications, thrombocytopenia, coagulation defects, cardiomyopathy, placenta previa, twin pregnancy, hypersensitivity to amide local anesthetics or fentanyl, infection at the injection site, neurologic disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group I<br>Pregnant with BMI<30 and having spinal anesthesia with 10 mg hyperbaric bupivacaine | Drug: Bupivacaine<br>* To compare low dose spinal anesthesia with bupivacaine alone if it can maintain surgical anesthesia during cesarean section in obese and non-obese pregnants<br>* Other names: Fentanyl;|
| Group II<br>Pregnant with BMI<30 and having spinal anesthesia with 7,5 mg hyperbaric bupivacaine+25 mcg fentanyl | Drug: Fentanyl<br>* To compare low dose spinal anesthesia with bupivacaine+ fentanyl alone if it can maintain surgical anesthesia during cesarean section in obese and non-obese pregnants<br>* Other names: Bupivacaine;|
| Group III<br>Pregnant with BMI>30 and having spinal anesthesia with 10 mg hyperbaric bupivacaine | Drug: Bupivacaine<br>* To compare low dose spinal anesthesia with bupivacaine alone if it can maintain surgical anesthesia during cesarean section in obese and non-obese pregnants<br>* Other names: Fentanyl;|
| Group IV<br>Pregnant with BMI>30 and having spinal anesthesia with 7,5 mg hyperbaric bupivacaine+25 mcg fentanyl | Drug: Fentanyl<br>* To compare low dose spinal anesthesia with bupivacaine+ fentanyl alone if it can maintain surgical anesthesia during cesarean section in obese and non-obese pregnants<br>* Other names: Bupivacaine;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS score < 6 with only spinal anesthesia | Achieving surgical anesthesia with low dose spinal anesthesia in obese pregnants | Approximately 30 min, during surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal hypotension | Avoiding maternal hypotension | Approximately 30 min, during surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal anesthesia, Cesarean, Maternal hypotension