Bupivacaine with Epinephrine for Shoulder Pain After Laparoscopy
This study is investigating if applying bupivacaine with epinephrine to the diaphragm during laparoscopic gynecologic surgery can reduce shoulder pain after the procedure. Bupivacaine is a local anesthetic (numbing medicine). While local anesthetics are known to help with general pain after surgery, this study is the first to look at spraying bupivacaine over the diaphragm to specifically target shoulder pain. Researchers will compare bupivacaine with epinephrine to a placebo (saline solution). The main goal is to see if participants who receive bupivacaine with epinephrine have lower shoulder pain scores 24 hours after surgery. You may be able to join if you are a woman aged 18 or older, undergoing laparoscopic gynecologic surgery at Cedars-Sinai Medical Center, and willing to follow all study procedures. The study is currently recruiting 100 participants.
- Study design
- This interventional study plans to enroll 100 women to compare bupivacaine with epinephrine to a placebo (saline).
- What's involved
- You would undergo laparoscopic gynecologic surgery at Cedars-Sinai Medical Center and your postoperative shoulder pain scores would be measured 24 hours after surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your postoperative shoulder pain scores will be measured at 24 hours after surgery.
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Bupivacaine With Epinephrine Over Diaphragm in Laparoscopy
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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Inclusion
Exclusion
What this trial measures
- Post-operative shoulder pain scores24 hours postoperatively
Reported right shoulder pain score using visual analog score (VAS) 24 hours postoperatively Null hypothesis = pain scores will not differ among the bupivacaine with epinephrine vs no intervention group Alternative hypothesis = pain scores will be lower among the bupivacaine with epinephrine group Assessed using the validated 100-mm scale with a range of 0-10 (11-point numerical rating scale), an ordinal scale Analyzed using the Kruskall Wallis test (as the data from the scale is typically not normally distributed); pairwise analyses will then be conducted using the Dunn post-hoc test if statistically significant Assuming non-normality, data will be presented as median (range) Patients without any postoperative documentation of pain scores will be withdrawn from the study and thus excluded from the analysis