Short Title: Standard vs. Lower Pressure Pneumoperitoneum

NCT06338865 | Recruiting

• 1 other identifier: Study00003146
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Laparoscopic Surgery

Keywords

laparoscopic surgery; insufflation; pneumoperitoneum; gynecologic surgery; postoperative pain; robotic surgery

Outcome Measures

Primary Outcomes (1)

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

  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."

  Postoperatively, before discharge from PACU (postoperative day 0)

Secondary Outcomes (12)

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

  Immediately upon arrival to PACU (postoperative day 0)

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

  Immediately prior to discharge from PACU (postoperative day 0)

• Inpatient morphine milligram equivalents

  Day of surgery (postoperative day 0)

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

  Assessed at postoperative day 14

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

  Intraoperative

Study Arms (6)

15mmHg (Conventional Laparoscopic Arm)

ACTIVE COMPARATOR

Standard Pressure, Conventional Laparoscopic Arm

Other: Carbon dioxide; Drug: Bupivacaine; Drug: Oxycodone

12mmHg (Conventional Laparoscopic Arm)

EXPERIMENTAL

Lower Pressure, Conventional Laparoscopic Arm

Other: Carbon dioxide; Drug: Bupivacaine; Drug: Oxycodone

10mmHg (Conventional Laparoscopic Arm)

EXPERIMENTAL

Lowest Pressure, Conventional Laparoscopic Arm

Other: Carbon dioxide; Drug: Bupivacaine; Drug: Oxycodone

15mmHg (Robotic-Assisted Laparoscopic Arm)

ACTIVE COMPARATOR

Standard Pressure, Robotic-Assisted Laparoscopic Arm

Other: Carbon dioxide; Drug: Bupivacaine; Drug: Oxycodone

12mmHg (Robotic-Assisted Laparoscopic Arm)

EXPERIMENTAL

Lower Pressure, Robotic-Assisted Laparoscopic Arm

Other: Carbon dioxide; Drug: Bupivacaine; Drug: Oxycodone

10mmHg (Robotic-Assisted Laparoscopic Arm)

EXPERIMENTAL

Lowest Pressure, Robotic-Assisted Laparoscopic Arm

Other: Carbon dioxide; Drug: Bupivacaine; Drug: Oxycodone

Interventions

Carbon dioxide OTHER

Gas used for insufflation pressure

10mmHg (Conventional Laparoscopic Arm); 10mmHg (Robotic-Assisted Laparoscopic Arm); 12mmHg (Conventional Laparoscopic Arm); 12mmHg (Robotic-Assisted Laparoscopic Arm); 15mmHg (Conventional Laparoscopic Arm); 15mmHg (Robotic-Assisted Laparoscopic Arm)

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).

10mmHg (Conventional Laparoscopic Arm); 10mmHg (Robotic-Assisted Laparoscopic Arm); 12mmHg (Conventional Laparoscopic Arm); 12mmHg (Robotic-Assisted Laparoscopic Arm); 15mmHg (Conventional Laparoscopic Arm); 15mmHg (Robotic-Assisted Laparoscopic Arm)

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.

10mmHg (Conventional Laparoscopic Arm); 10mmHg (Robotic-Assisted Laparoscopic Arm); 12mmHg (Conventional Laparoscopic Arm); 12mmHg (Robotic-Assisted Laparoscopic Arm); 15mmHg (Conventional Laparoscopic Arm); 15mmHg (Robotic-Assisted Laparoscopic Arm)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of 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 opioid use
• Allergy or intolerance to bupivacaine (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

RECRUITING

MeSH Terms

Conditions

Pneumoperitoneum; Pain, Postoperative

Interventions

Carbon Dioxide; Bupivacaine; Oxycodone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Carbon Compounds, Inorganic; Inorganic Chemicals; Gases; Oxides; Oxygen Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Matthew Siedhoff, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Schneyer, MD

CONTACT

914-391-2604; rebecca.schneyer@cshs.org

Rebekah Odum, BSN

CONTACT

rebekah.odum@cshs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients and post-anesthesia care unit nurses will be masked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair for Gynecology

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: April 1, 2024
• Study Start: May 3, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)