Bupivacaine With Epinephrine Over Diaphragm in Laparoscopy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCedars-Sinai Medical Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Pregnancy
Urgent/non-scheduled surgery
Scheduled for planned or possible concomitant non-gynecologic surgery (e.g., urologic or colorectal procedure)
Baseline shoulder pain
Trial design
Design model
Parallel
Treatments tested in this trial
Instillation of Bupivacaine with epinephrine over the diaphragm
DrugPrior 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Bupivacaine with epinephrineExperimental treatment 1 intervention
Group B: No interventionNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Post-operative shoulder pain scores
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
Time frame
24 hours postoperativelySecondary outcomes
1
Post-operative generalized pain scores
Post-operative generalized pain scores (superiority): 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 First and last reported generalized pain score in post-anaesthesia care unit (PACU) using numerical rating score Assessed using the validated 11-point numerical rating scale (0-10), 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
Time frame
up to 6 hours in post-anaesthesia care unit (PACU)2
Total analgesic requirements in post-anaesthesia care unit (PACU) in morphine equivalents
Calculated in morphine milligram equivalents (continuous data) Analyzed using the Kruskall-Wallis test (assuming non-normal data) Data will be presented as median (range)
Time frame
up to 6 hours in post-anaesthesia care unit (PACU)3
Length of stay in post-anaesthesia care unit (PACU)
Length of stay in post-anaesthesia care unit (PACU) (superiority): Null hypothesis = PACU length of stay will not differ among the bupivacaine with epinephrine vs no intervention group Alternative hypothesis= PACU length of stay will be shorter in the bupivacaine with epinephrine groups Documented in minutes (continuous data) Analyzed using ANOVA if normally distributed, Kruskall-Wallis test if not normally distributed
Time frame
up to 6 hours in post-anaesthesia care unit (PACU)4
Post-operative shoulder pain scores at home
Daily reported post-operative shoulder pain scores at home (superiority): 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
Time frame
7 days postoperativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov