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

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

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.

Study Overview

• Status: Unknown
• Conditions: Cesarean Section; Anesthesia, Spinal; Local Anaesthetics Causing Adverse Effects in Therapeutic Use
• Intervention / Treatment: Drug: Bupivacaine; Drug: Bupivacaine and Fentanyl

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Boris Yanovsky, MD; Phone Number: +972 50 626788; Email: boris.yanovsky@b-z.org.il

Study Locations

• Israel
  • Haifa, Israel
    • Bnai Zion Medical Center
    • Contact: Boris Yanovsky, MD; Email: boris.yanovsky@b-z.org.il
    • Principal Investigator: Boris Yanovsky, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Drug: Bupivacaine; Spinal anesthesia with Marcaine Spinal 0.5% Heavy 12.5 mg (2.5 ml); Other Names: Marcaine Spinal 0.5% Heavy
Experimental: 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)	Drug: 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); Other Names: Marcaine Spinal 0.5% Heavy; Fentanyl-Janssen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prominence of motor blockade	At the begining of the surgery and at the entry of the patients to PACU motor block will be evaluated	up to 2 h

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operative condition	Upon completion of surgery attending surgeon will be asked to rate the operative condition.	up to 1 h
intraoperative hypotension	Number of treatments for hypotensions during the surgery will be monitored.	up to 1 h
need for postoperative pain medication	The pain or discomfort intensity during the surgery, and at PACU will be graded.	up to 2 h
general patient satisfaction	On the next day, all patients will be asked to rate their satisfaction following the anesthesia.	after 24 h

Collaborators and Investigators

• Sponsor: Bnai Zion Medical Center
• Investigators: Principal Investigator: Boris Yanovsky, MD, Bnai Zion Medical Center, Haifa, Israel

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Anticipated): January 1, 2012
• Study Completion (Anticipated): January 1, 2012

Study Registration Dates

• First Submitted: January 20, 2011
• First Submitted That Met QC Criteria: February 23, 2011
• First Posted (Estimate): February 25, 2011

Study Record Updates

• Last Update Posted (Estimate): February 25, 2011
• Last Update Submitted That Met QC Criteria: February 23, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: Cesarean section; Spinal anesthesia; Fentanyl; Local Anesthetics; Marcaine Spinal 0.5% Heavy minidose
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Fentanyl; Bupivacaine
• Other Study ID Numbers: 0123-10-BZ