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

Cesarean Section Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01303731
• Other study ID #: 0123-10-BZ
• Status: Not yet recruiting
• Phase: Phase 4
• First received: January 20, 2011
• Last updated: February 23, 2011
• Start date: February 2011
• Est. completion date: January 2012

Study information

• Verified date: January 2011
• Source: Bnai Zion Medical Center
• Contact: Boris Yanovsky, MD
• Phone: +972 50 626788
• Email: boris.yanovsky[@]b-z.org.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Israel	Bnai Zion Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Bnai Zion Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	operative condition	Upon completion of surgery attending surgeon will be asked to rate the operative condition.	up to 1 h	Yes
Secondary	intraoperative hypotension	Number of treatments for hypotensions during the surgery will be monitored.	up to 1 h	Yes
Secondary	need for postoperative pain medication	The pain or discomfort intensity during the surgery, and at PACU will be graded.	up to 2 h	No
Secondary	general patient satisfaction	On the next day, all patients will be asked to rate their satisfaction following the anesthesia.	after 24 h	No