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Laparoscopic Surgery Pain Study: Standard vs. Lower Pressure Pneumoperitoneum

This study is looking at how different levels of gas pressure during laparoscopic surgery (a type of minimally invasive surgery) affect pain after the operation. Researchers are comparing standard pressure (15mmHg) with lower pressures (12mmHg and 10mmHg) to see if lower pressure can reduce pain without making it harder for the surgeon to see. All patients will receive bupivacaine (a local anesthetic) at the incision sites and oxycodone (a pain medication) after surgery. The main goal is to measure your maximum pain score in the recovery room. You may be able to join if you are 18 or older, female, and having laparoscopic gynecologic surgery at Cedars-Sinai Medical Center. The current status of this study is unclear.

Study design
This is a single-center, single-blinded randomized controlled trial with 294 planned participants. Participants will be randomly assigned to one of three groups (15mmHg, 12mmHg, or 10mmHg pressure) for their laparoscopic surgery.
What's involved
You would need to provide signed consent and be available for the duration of the study. The study involves undergoing laparoscopic surgery with specific insufflation pressures and having your pain measured after the procedure.
Compensation
Not stated in the trial record.
Follow-up
Your pain will be measured before discharge from the post-anesthesia care unit (PACU) on postoperative day 0.

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NCT06338865

Short Title: Standard vs. Lower Pressure Pneumoperitoneum

Recruiting
NAAges 18+InterventionalPrevention
Cedars-Sinai Medical Center
~294 participants
Updated 2024-05-10 on ClinicalTrials.gov
What's tested:Carbon dioxideBupivacaineOxycodone

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum documented pain score in post-anesthesia care unit (PACU) (numerical rating scale, 0-10)
Measured over Postoperatively, before discharge from PACU (postoperative day 0)

Conditions

Laparoscopic Surgery

Explore related trials

Gynecological Surgical ProcedureLaparoscopic Surgery

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Matthew Siedhoff, MD · PRINCIPAL_INVESTIGATOR · Cedars-Sinai Medical Center

Who to contact

Rebecca Schneyer, MD
[email protected]
914-391-2604
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

Pregnancy
Urgent/non-scheduled surgery
Scheduled for planned or possible concomitant non-gynecologic surgery (e.g., urologic or colorectal procedure)
Baseline opioid use
Allergy or intolerance to bupivacaine (or amide class of anesthetics), oxycodone, acetaminophen, or ibuprofen
Planned post-operative admission

What this trial measures

  • Maximum documented pain score in post-anesthesia care unit (PACU) (numerical rating scale, 0-10)Postoperatively, before discharge from PACU (postoperative day 0)

    The numerical rating scale is a pain screening tool that is routinely used to assess pain severity in the postoperative setting using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable."