A Phase 4 interventional study of Bupivacaine and Fentanyl and Bupivacaine in Cesarean Section, Anesthesia, Spinal and Local Anaesthetics Causing Adverse Effects in Therapeutic Use, sponsored by Bnai Zion Medical Center. Status unknown at 1 site in Israel. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-02-25.
Sponsored by Bnai Zion Medical Center · Phase 4, Interventional, and Treatment
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.
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.
Bnai Zion Medical Center is the lead sponsor of 102 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard group - will receive spinal anesthesia induced by Marcaine Spinal 0.5% Heavy 12.5 mg (2.5 ml).
Drug: Bupivacaine
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)
Also known as: Marcaine Spinal 0.5% Heavy, Fentanyl-Janssen
Spinal anesthesia with Marcaine Spinal 0.5% Heavy 12.5 mg (2.5 ml)
Also known as: Marcaine Spinal 0.5% Heavy
prominence of motor blockade
At the begining of the surgery and at the entry of the patients to PACU motor block will be evaluated
Time frame: up to 2 h
operative condition
Upon completion of surgery attending surgeon will be asked to rate the operative condition.
Time frame: up to 1 h
intraoperative hypotension
Number of treatments for hypotensions during the surgery will be monitored.
Time frame: up to 1 h
need for postoperative pain medication
The pain or discomfort intensity during the surgery, and at PACU will be graded.
Time frame: up to 2 h
general patient satisfaction
On the next day, all patients will be asked to rate their satisfaction following the anesthesia.
Time frame: after 24 h
This study is status unknown, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Bnai Zion Medical Center