Recruiting

Bupivacaine

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT07400146

Conditions

Postoperative Pain

Shoulder Pain

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Instillation of Bupivacaine with epinephrine over the diaphragm

Study Details

Brief summary:

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.

Conditions

Postoperative Pain

Shoulder Pain

Study ID

NCT07400146

Start date

Mar 2, 2026

Status verified date

Sep, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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:

  • Pregnancy
  • 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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Bupivacaine with epinephrine

Participants randomized to this arm will have 30 mL of 0.25% bupivacaine with epinephrine 1:200,000 (total of 75 mg) placed over the diaphragm laparoscopically at the conclusion of the laparoscopic gynecologic procedure.

no intervention: No intervention

No additional intervention will be performed.

Interventions

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 measure

  • Post-operative shoulder pain scores [ Time Frame: 24 hours postoperatively ]

Central Contacts and Locations

Central contacts

Ogechukwu Ezike, MD

3473371181ogechukwu.ezike@cshs.org

Kelly Wright, MD

kelly.wright@cshs.org

Locations

Cedars Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Ogechukwu Ezike, MD

3473371181ogechukwu.ezike@cshs.org

Principal Investigator:

Kelly Wright, MD

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Sep 30, 2026

Last verified

Sep, 2026

Keywords

  • Laparoscopy
  • Gynecologic surgery
  • Bupivacaine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-01. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2026-09-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.