Comparison of Standard and Minidose Spinal Anesthesia for Cesarean Section Operation Using Marcaine Spinal 0.5% Heavy
Information source: Bnai Zion Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cesarean Section; Anesthesia, Spinal; Local Anaesthetics Causing Adverse Effects in Therapeutic Use
Intervention: Bupivacaine and Fentanyl (Drug); Bupivacaine (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Bnai Zion Medical Center Official(s) and/or principal investigator(s): Boris Yanovsky, MD, Principal Investigator, Affiliation: Bnai Zion Medical Center, Haifa, Israel
Overall contact: Boris Yanovsky, MD, Phone: +972 50 626788, Email: boris.yanovsky@b-z.org.il
Summary
The objectives of this study is to test a combination of low dose local anesthetic
Bupivacaine diluted in patient's CSF with lipophilic opiate Fentanyl for optimal spinal
anesthesia during Cesarean Section. The dilution of Bupivacaine with CSF in our study would
result in effective spinal anesthesia with relatively limited motor block, quick recovery of
motor function and relatively long lasting analgesia. We expect lower incidence of side
effects with this combination than with convenient dose of Bupivacaine.
Clinical Details
Official title: Phase IV, Randomized, Parallel Designed, Single Blinded Study, Comparing the Standard and Minidose Spinal Anesthesia Using Marcaine Spinal 0.5% Heavy With Addition of Fentanyl During Cesarean Section
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: prominence of motor blockade
Secondary outcome: operative conditionintraoperative hypotension need for postoperative pain medication general patient satisfaction
Detailed description:
Spinal anesthesia is the most frequent type of anesthesia used for Cesarian Section.
However, despite decades of safe utilization there is still controversy about the best
combination of local anesthetics and additives needed to obtain the optimal result. The
objectives of this study is to test a combination of low dose local anesthetic Bupivacaine
diluted in patient's CSF with lipophilic opiate Fentanyl for compliance with the criteria of
optimal spinal anesthesia. Bupivacaine is the most frequently used local anesthetic in the
last twenty years . It characterized by fast onset, high potency and long action . Albeit
this is intrinsic characteristic of specific local anesthetic, its manifestation can be
affected by concentration. It has been shown that dilution of local anesthetic with CSF can
result in sensory block with less profound motor block.
Thus dilution of Bupivacaine with CSF in our study would serve double function: it would
speed the recovery from the spinal anesthesia and minimize the expression of the motor
block. Addition of opiates to local anesthetics has been widely used . It has been shown that
this addition improves quality of spinal anesthesia and prolongs analgesia without
significant prolongation of recovery from motor block.
In summary, we would use well known safe local anesthetic Bupivacaine in low dose and low
concentration (after dilution with patient's CSF) in conjunction with highly lipophilic
opiate Fentanyl. We suppose it will result in effective spinal anesthesia with relatively
limited motor block, quick recovery of motor function and relatively long lasting analgesia.
We expect lower incidence of side effect with this combination than with convenient dose of
Bupivacaine.
Good pain relief and swift restoration of ability to ambulate will be important for
prevention of postoperative complications, will diminish the need for systemic analgetic
drugs that can affect nursing and will increase patients' satisfaction.
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Women over 38 weeks of pregnancy, who read and write Hebrew
- ASA class I and II
- Age between 18 and 40 years
- Weight 50-100 kg
- Elective Cesarean Section for singlet pregnancy
Exclusion Criteria:
- Previous history of two or more Cesarean Sections
- Contraindications for regional anesthesia
- Active pain before surgery
- Non singlet pregnancy
Locations and Contacts
Boris Yanovsky, MD, Phone: +972 50 626788, Email: boris.yanovsky@b-z.org.il
Bnai Zion Medical Center, Haifa, Israel; Not yet recruiting Boris Yanovsky, MD, Email: boris.yanovsky@b-z.org.il Boris Yanovsky, MD, Principal Investigator
Additional Information
Starting date: February 2011
Last updated: February 23, 2011
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