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NCT Number: NCT06338865

Short Title: Standard vs. Lower Pressure Pneumoperitoneum

This study aims to investigate the effect of varying insufflation pressures on post-operative pain and adequacy of surgical field visualization among patients undergoing laparoscopic surgery with a minimally invasive gynecologic surgeon.

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Key information

Conditions

Laparoscopic Surgery Digestive System Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Peritoneal Diseases Pneumoperitoneum Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location status: Recruiting

Location contact

Rebecca Schneyer, MD

CONTACT

[email protected]

914-391-2604

About this study

This will be a single-center, single-blinded randomized controlled trial evaluating the impact of lower pressure pneumoperitoneum on post-operative pain and surgical field visualization among patients undergoing laparoscopic gynecologic surgery. The investigators hypothesize that lower insufflation pressures will decrease post-operative pain in the immediate post-operative period without compromising surgical field visualization. The study will include 3 groups corresponding to varying insufflation pressures: 15mmHg (standard), 12mmHg and 10mmHg. Participants will be 1:1:1 allocated to the 15mmHg, 12mmHg or 10mmHg groups (parallel design) by block randomization.

Given inherent differences in how pneumoperitoneum is maintained during conventional versus robotic-assisted laparoscopic surgery, the investigators will be enrolling patients in two separate arms depending on their planned procedure:

  • Standard vs. Lower Pressure Pneumoperitoneum in Conventional Laparoscopic Gynecologic Surgery
  • Standard vs. Lower Pressure Pneumoperitoneum in Robotic-Assisted Laparoscopic Gynecologic Surgery.

The methodology for the two arms will be otherwise identical.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Carbon dioxide

Other

Gas used for insufflation pressure

Bupivacaine

Drug

Local subcutaneous infiltration of all port sites with 0.25% bupivacaine will be performed prior to each incision. Remaining local anesthetic will be administered into the incision sites prior to the conclusion of the case (30cc total).

Oxycodone

Drug

All patients will be prescribed a total of 10 pills of oxycodone 5mg, which is the standard amount that our practice prescribes for patients after laparoscopic surgery.

Primary outcomes

  1. Maximum documented pain score in post-anesthesia care unit (PACU) (numerical rating scale, 0-10)

    Time frame: 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."

Secondary outcomes

  1. First reported pain score in PACU (numerical rating scale, 0-10)

    Time frame: Immediately upon arrival to 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."

  2. Last reported pain score in PACU prior to discharge (numerical rating scale, 0-10)

    Time frame: Immediately prior to 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."

  3. Inpatient morphine milligram equivalents

    Time frame: Day of surgery (postoperative day 0)

    Daily total of opioid medications administered on the day of surgery

  4. Total number of 5mg oxycodone pills taken in the 2 weeks following discharge

    Time frame: Assessed at postoperative day 14

  5. Need for insufflation pressure increase intra-operatively due to inadequate visualization

    Time frame: Intraoperative

  6. Operative time

    Time frame: Intraoperative

  7. Estimated blood loss

    Time frame: Intraoperative

  8. Intraoperative complications

    Time frame: Intraoperative

  9. Conversion to laparotomy

    Time frame: Intraoperative

  10. Postoperative length of stay

    Time frame: Postoperatively, before discharge from PACU (postoperative day 0)

    From arrival to PACU to discharge home

  11. Surgeon-reported adequacy of assigned insufflation pressure

    Time frame: Immediately following surgery

    Surgeons will rate their agreement with the following statement on a 5-point Likert scale (from strongly disagree to strongly agree): "The assigned insufflation pressure was adequate for this procedure"

  12. Need for adjustment of insufflation pressure

    Time frame: Intraoperative

    In a post-op questionnaire, surgeons will indicate whether the insufflation pressure was adjusted at any point during the procedure (yes/no).

Study contacts

Contact information is provided by the study sponsor or research team.

Rebecca Schneyer, MD

CONTACT

[email protected]

914-391-2604

Rebekah Odum, BSN

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

Standard vs. Lower Pressure Pneumoperitoneum in Laparoscopic Gynecologic Surgery: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 1, 2024
Registry last updated
May 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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