Bupivacaine With Epinephrine Over Diaphragm in Laparoscopy

NCT07400146 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: STUDY00003947
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Laparoscopy; Gynecologic surgery; Bupivacaine

Outcome Measures

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data will be presented as median (range) Patients without any postoperative documentation of pain scores will be withdrawn from the study and thus excluded from the analysis

  24 hours postoperatively

Secondary Outcomes (9)

• Post-operative generalized pain scores

  up to 6 hours in post-anaesthesia care unit (PACU)

• Total analgesic requirements in post-anaesthesia care unit (PACU) in morphine equivalents

  up to 6 hours in post-anaesthesia care unit (PACU)

• Length of stay in post-anaesthesia care unit (PACU)

  up to 6 hours in post-anaesthesia care unit (PACU)

• Post-operative shoulder pain scores at home

  5 days postoperatively

• Post-operative opioid use

  1 week postoperative

Study Arms (2)

Bupivacaine with epinephrine

EXPERIMENTAL

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.

Drug: Instillation of Bupivacaine with epinephrine over the diaphragm

No intervention

NO INTERVENTION

No additional intervention will be performed.

Interventions

Instillation of Bupivacaine with epinephrine over the diaphragm DRUG

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.

Bupivacaine with epinephrine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide a signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• years of age or older
• Undergoing laparoscopic surgery at Cedars-Sinai Medical Center with a surgeon in the Minimally Invasive Gynecologic Surgery division.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (18)

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MeSH Terms

Conditions

Pain, Postoperative; Shoulder Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Arthralgia; Joint Diseases; Musculoskeletal Diseases

Central Study Contacts

Ogechukwu Ezike, MD

CONTACT

3473371181; ogechukwu.ezike@cshs.org

Kelly Wright, MD

CONTACT

kelly.wright@cshs.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are randomized into either the treatment arm with placement of bupivacaine with epinephrine over the diaphragm or the no intervention arm. Participants are blinded to whether or not they received the intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Director of Minimally Invasive Gynecologic Surgery

Model Details: Randomized control trial, single blind study

Study Record Dates

• First Submitted: January 24, 2026
• First Posted: February 10, 2026
• Study Start: February 1, 2026
• Primary Completion: July 1, 2026
• Study Completion: August 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)