Comparison of Standard and Minidose Spinal Anesthesia for Cesarean Section Operation Using Marcaine Spinal 0.5% Heavy
Recruitment status was: Not yet recruiting
Local Anaesthetics Causing Adverse Effects in Therapeutic Use
Drug: Bupivacaine and Fentanyl
|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|
- 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
- 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.
|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)|
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).
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)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01303731
|Bnai Zion Medical Center|
|Principal Investigator:||Boris Yanovsky, MD||Bnai Zion Medical Center, Haifa, Israel|