Comparison of Standard and Minidose Spinal Anesthesia for Cesarean Section Operation Using Marcaine Spinal 0.5% Heavy

NCT ID: NCT01303731

Last Updated: 2011-02-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2012-01-31

Brief 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.

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.

Conditions

Cesarean Section; Anesthesia, Spinal; Local Anaesthetics Causing Adverse Effects in Therapeutic Use

Keywords

Spinal anesthesia; Cesarean section; Marcaine Spinal 0.5% Heavy minidose; Fentanyl; Local Anesthetics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard dose Marcaine Spinal 0.5% Heavy

Standard group - will receive spinal anesthesia induced by Marcaine Spinal 0.5% Heavy 12.5 mg (2.5 ml).

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: DRUG

Spinal anesthesia with Marcaine Spinal 0.5% Heavy 12.5 mg (2.5 ml)

Minidose of Marcaine Spinal 0.5% Heavy

Minidose group - will receive spinal anesthesia induced by Marcaine Spinal 0.5% Heavy 7.5 mg (1.5 ml) diluted in 0.75ml of patient's CSF (0.25 ml)with addition of Fentanyl 12.5 mcg (total 2.5 ml)

Group Type: EXPERIMENTAL

Bupivacaine and Fentanyl

Intervention Type: DRUG

Spinal anesthesia with Marcaine Spinal 0.5% Heavy 7.5 mg (1.5 ml) diluted in 0.75ml of patient's CSF (0.25 ml)with addition of Fentanyl 12.5 mcg (total 2.5 ml)

Interventions

Bupivacaine and Fentanyl

Spinal anesthesia with Marcaine Spinal 0.5% Heavy 7.5 mg (1.5 ml) diluted in 0.75ml of patient's CSF (0.25 ml)with addition of Fentanyl 12.5 mcg (total 2.5 ml)

Intervention Type: DRUG

Bupivacaine

Spinal anesthesia with Marcaine Spinal 0.5% Heavy 12.5 mg (2.5 ml)

Intervention Type: DRUG

Other Intervention Names

Marcaine Spinal 0.5% Heavy; Fentanyl-Janssen; Marcaine Spinal 0.5% Heavy

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bnai Zion Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Bnai Zion Medical Center, Haifa, Israel

Principal Investigators

Boris Yanovsky, MD

Role: PRINCIPAL_INVESTIGATOR

Bnai Zion Medical Center, Haifa, Israel

Locations

Bnai Zion Medical Center

Haifa, , Israel

Countries

Israel

Central Contacts

Boris Yanovsky, MD

Role: CONTACT

Phone: +972 50 626788

Email: boris.yanovsky@b-z.org.il

Facility Contacts

Boris Yanovsky, MD

Role: primary

Other Identifiers

0123-10-BZ

Identifier Type: -

Identifier Source: org_study_id