A Phase 1 interventional study of Spinal Anesthesia with Bupivacaine and Fentanyl and Spinal Anesthesia with Bupivacaine and Midazolam in Healthy Female Volunteer, sponsored by Makassed General Hospital. Active, not recruiting at 1 site in Lebanon. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-09.
Sponsored by Makassed General Hospital · Phase 1, Interventional, and Treatment
It is well documented in the practice of anesthesia the effectiveness of bupivacaine when added with other adjuvants including midazolam, opioids, and ketamine during neuraxial spinal block for cesarean delivery, however comparison of the superiority of midazolam 2mg over fentanyl 25 micrograms or vice versa with bupivacaine during cesarean delivery has not been established and if performed diligently, could potentially change our understanding and current practice for better patient outcomes.
A study published on Jan - Feb 2024 has compared adjuvants fentanyl 25 micrograms and midazolam 2mg when added to Levobupivacaine for patients undergoing cesarean section with Midazolam being the superior drug of choice with less side effects. [1] Another study done around our locality at the American University of Beirut compared the postoperative analgesic effect of ketamine and fentanyl when added to bupivacaine in patients undergoing cesarean section with results conclusive of equally effective post cesarean pain control. [2] One study compared intrathecal midazolam 2mg with intrathecal fentanyl 12.5 micrograms with bupivacaine [3], and results elucidated equal surgical analgesia during the operation in contrast to the superior Midazolam 2mg vs the intrathecal fentanyl 25 micrograms when added to levobupivacaine mentioned in the first study. Current literature is void of studies comparing intrathecal fentanyl 25 micrograms vs intrathecal midazolam 2mg when added to bupivacaine for cesarean delivery.
Study objectives:
Comparative studies are available for different adjuvants when administered along with bupivacaine or levobupivacaine, but the specific aim and target of this study is to compare Hyperbaric Bupivacaine 0.5% 12.5 mg with fentanyl 25 micrograms (2 ml) versus Hyperbaric Bupivacaine 0.5% 12.5 mg with midazolam 2mg (2 ml) for cesarean delivery.
Levobupivacaine is not as readily available as bupivacaine in our population. Opioids have significantly more side effects when administered intrathecally including pruritus, respiratory depression, post operatively nausea and vomiting, and any attempt to decrease their usage to improve patient satisfaction without compromising the overall analgesic effect should be pursued. The results from this study could potentially change current practice in our hospital and across local and national areas respectively.
This study aims to provide conclusive data about the superiority of midazolam in reduction of postoperative pain, reduction of postoperative rescue analgesia, the quality of sensory block, and the reduction in side effects when administered with Bupivacaine as opposed to Levobupivacaine which was demonstrated in the study [1] mentioned above.
Makassed General Hospital is the lead sponsor of 39 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Spinal Anesthesia with Bupivacaine and Fentanyl
Drug: Spinal Anesthesia with Bupivacaine and Midazolam
Drug pages: Bupivacaine · Fentanyl
25 mcg Fentanyl 12.5 mg Bupivacaine
Drug pages: Bupivacaine · Midazolam
2 Mg Midazolam 12.5 mg Bupivacaine
rescue analgesia
The primary outcome is the timing of the first analgesia requested postoperatively (i.e., the rescue analgesia).
Time frame: 24 Hours
Plan to share: No
Started Apr 2025 (actual). Primary completion is estimated for Apr 2026, 12 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Apr 2025. 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.
Studies of the drugs tested here: Bupivacaine · Fentanyl · Midazolam
Makassed General Hospital