Maneuvers to Reduce Laparoscopic Pain

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Henry Ford Health System
Study ID
NCT07583433
Status
Not Yet Recruiting

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Conditions

  • Laparoscopic Surgery
  • Pneumoperitoneum
  • Post Operative Pain, Acute

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Smoke Evacuation Group — PROCEDURE
    Active gas removal via smoke evacuator for 30 seconds at the end of case.
  • Recruitment Breath Group — PROCEDURE
    Repeated pulmonary inflation maneuvers: Three (3) consecutive manual ventilations at maximum of 30 cm water at the end of case.
  • Control Group — PROCEDURE
    Passive desolation of the pneumoperitoneum at the end of the laparoscopic surgery.

Study Details

Laparoscopic surgery has revolutionized surgical care by reducing morbidity and improving post operative recovery. Laparoscopic surgery involves the use of carbon dioxide for insufflation to achieve optimal visualization. There is literature that demonstrates higher insufflation pressures being associated with increased postoperative pain - particularly shoulder pain - and opioid use. The ideal amount of intraperitoneal pressure is still under debate as other studies demonstrate that reduced pneumoperitoneum insufflation has also shown to negatively impact surgeon satisfaction and trended with longer operative time and greater blood loss without impacting pain. Residual intraperitoneal carbon dioxide can also contribute to postoperative discomfort. Studies have shown the effectiveness of various maneuvers in removing residual gas to reduce postoperative pain, such as intraperitoneal saline instillation, pulmonary recruitment, and gas aspiration via smoke evacuator. Despite these advantages, there is a lack of a clear consensus on the optimal method for reducing residual intraperitoneal gas. Conversely, literature has mixed results regarding the true significance in pain reduction. Given the importance of minimizing postoperative pain, reducing opioid requirements, and shortening postoperative recovery time, the investigators propose a prospective, patient-blinded, randomized controlled trial. The investigators aim to investigate whether active gas removal via a smoke evacuator, multiple breath recruitment maneuvers, or no intervention would contribute to lowest postoperative pain. The findings will help identify the most effective method for reducing residual pneumoperitoneum-related pain and thus inform surgical practices and improve patient outcomes.

Key Dates

Start date
Jul 10, 2026
Status verified
Jun 2026
Primary completion
Aug 31, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Smoke Evacuation Group
  • Experimental: Recruitment Breath Group
  • Placebo Comparator: Control Group

Primary Outcome Measure

Post operative pain [ Time Frame: From enrollment until 1 week post surgery ]

Locations (1)

FacilityCityStateZIPSite coordinators
Henry Ford HospitalDetroitMichigan48202
Ilinca Lupea, MD
[email protected]
313-425-4567
Ilinca Lupea, MD (PRINCIPAL_INVESTIGATOR)

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Henry Ford Hospital· Detroit, MI

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