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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Bnai Zion Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Bnai Zion Medical Center
ClinicalTrials.gov Identifier:
NCT01303731
First received: January 20, 2011
Last updated: February 23, 2011
Last verified: January 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Cesarean Section
Anesthesia, Spinal
Local Anaesthetics Causing Adverse Effects in Therapeutic Use
 Drug: Bupivacaine and Fentanyl
Drug: Bupivacaine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cesarean Section
U.S. FDA Resources

Further study details as provided by Bnai Zion Medical Center:

Primary Outcome Measures:
  • prominence of motor blockade [ Time Frame: up to 2 h ] [ Designated as safety issue: No ]
    At the begining of the surgery and at the entry of the patients to PACU motor block will be evaluated


Secondary Outcome Measures:
  • operative condition [ Time Frame: up to 1 h ] [ Designated as safety issue: Yes ]
    Upon completion of surgery attending surgeon will be asked to rate the operative condition.

  • intraoperative hypotension [ Time Frame: up to 1 h ] [ Designated as safety issue: Yes ]
    Number of treatments for hypotensions during the surgery will be monitored.

  • need for postoperative pain medication [ Time Frame: up to 2 h ] [ Designated as safety issue: No ]
    The pain or discomfort intensity during the surgery, and at PACU will be graded.

  • general patient satisfaction [ Time Frame: after 24 h ] [ Designated as safety issue: No ]
    On the next day, all patients will be asked to rate their satisfaction following the anesthesia.


Estimated Enrollment: 100
Study Start Date: February 2011
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01303731

Contacts
Contact: Boris Yanovsky, MD +972 50 626788 boris.yanovsky@b-z.org.il

Locations
Israel
Bnai Zion Medical Center Not yet recruiting
Haifa, Israel
Contact: Boris Yanovsky, MD         boris.yanovsky@b-z.org.il    
Principal Investigator: Boris Yanovsky, MD            
Sponsors and Collaborators
Bnai Zion Medical Center
Investigators
Principal Investigator: Boris Yanovsky, MD Bnai Zion Medical Center, Haifa, Israel
  More Information

No publications provided

Responsible Party: Dr Boris Yanovsky, Bnai Zion Medical Center, Haifa, Israel
ClinicalTrials.gov Identifier: NCT01303731     History of Changes
Other Study ID Numbers: 0123-10-BZ
Study First Received: January 20, 2011
Last Updated: February 23, 2011
Health Authority: Israel: Ethics Commission

Keywords provided by Bnai Zion Medical Center:
Spinal anesthesia
Cesarean section
Marcaine Spinal 0.5% Heavy minidose
Fentanyl
Local Anesthetics

Additional relevant MeSH terms:
Anesthetics
Bupivacaine
Fentanyl
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
 Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Narcotics
Analgesics
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 19, 2013