NCT07400146 · Cedars-Sinai Medical Center
Bupivacaine With Epinephrine Over Diaphragm in Laparoscopy
What this study is about
Postoperative shoulder pain is often reported to be particularly bothersome after laparoscopy. The benefits of local anesthetic, such as bupivacaine, applied to injected under the skin tissue for general postoperative pain management after surgery is well established. However, there have been no studies on sprayed bupivacaine over the diaphragm to reduce shoulder pain in laparoscopic surgery.
View original scientific description
Postoperative shoulder pain is often reported to be particularly bothersome after laparoscopy. The benefits of local anesthetic, such as bupivacaine, applied to subcutaneous tissue for general postoperative pain management after surgery is well established. However, there have been no studies on sprayed bupivacaine over the diaphragm to reduce shoulder pain in laparoscopic surgery. The purpose of the study is to evaluate if sprayed infra-diaphragmatic bupivacaine compared to placebo (saline) will improve postoperative shoulder pain in patients undergoing benign laparoscopic gynecologic surgery. The entire study will be conducted at Cedar Sinai Medical Center.
Interventions
DRUG
Instillation of Bupivacaine with epinephrine over the diaphragm
Prior to desufflation of the abdomen during the laparoscopic gynecologic procedure, the surgeon will instill 30mL of 0.25% bupivacaine with epinephrine 1:200,000 (total of 75 mg) laparoscopically aiming to cover the diaphragm with liquid.
Primary outcome measures
Post-operative shoulder pain scores
Time frame: 24 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data will be presented as median (range) Patients without any postoperative documentation of pain scores will be withdrawn from the study and thus excluded from the analysis
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Provide a signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- 8 years of age or older
- Undergoing laparoscopic surgery at Cedars-Sinai Medical Center with a surgeon in the Minimally Invasive Gynecologic Surgery division.
Exclusion criteria
- Urgent/non-scheduled surgery
- Scheduled for planned or possible concomitant non-gynecologic surgery (e.g., urologic or colorectal procedure)
- Baseline shoulder pain
- Baseline opioid use
- Baseline of chronic pain syndrome
- Conversion to open surgery
- Allergy or intolerance to bupivacaine, lidocaine (or amide class of anesthetics), oxycodone, acetaminophen, or ibuprofen
- Planned post-operative admission
Where
- Los Angeles, California
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Frequently asked questions
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Data: ClinicalTrials.gov · synced Sep 30, 2026 · Source of record for eligibility and locations