Maneuvers to Reduce Laparoscopic Pain

NCT07583433 | Not Yet Recruiting

• 1 other identifier: 18542-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Laparoscopic Surgery; Pneumoperitoneum; Post Operative Pain, Acute

Outcome Measures

Primary Outcomes (1)

• Post operative pain

  Post-operative pain: Patients will be assessed using the Numeric Rating Scale (NRS) by rating their pain on a scale from 0 (no pain) to 10 (worst pain imaginable) immediately prior to leaving the post-anesthesia care unit, on post-operative day 2, and post-operative day 7.

  From enrollment until 1 week post surgery

Secondary Outcomes (1)

• Opioid use for the management of post operative pain

  Time of enrollment until their post operative appointment up to 2 weeks from the time of surgery

Study Arms (3)

Smoke Evacuation Group

EXPERIMENTAL

Procedure: Smoke Evacuation Group

Recruitment Breath Group

EXPERIMENTAL

Procedure: Recruitment Breath Group

Control Group

PLACEBO COMPARATOR

Procedure: Control Group

Interventions

Smoke Evacuation Group PROCEDURE

Active gas removal via smoke evacuator for 30 seconds at the end of case.

Smoke Evacuation Group

Recruitment Breath Group PROCEDURE

Repeated pulmonary inflation maneuvers: Three (3) consecutive manual ventilations at maximum of 30 cm water at the end of case.

Recruitment Breath Group

Control Group PROCEDURE

Passive desolation of the pneumoperitoneum at the end of the laparoscopic surgery.

Control Group

Eligibility Criteria

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

You may qualify if:

• Patients age 18 to 65
• Benign, elective laparoscopic surgeries

You may not qualify if:

• Ages \<18 and age \>65
• Emergency or urgent surgeries
• Surgeries for chronic pelvic pain, malignancy
• Surgeries during pregnancy
• Severe cardiopulmonary disease
• Prior extensive abdominal surgeries (more than 2 abdominal or pelvic surgeries)
• Inability to consent

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Pneumoperitoneum

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 13, 2026
• Study Start: July 10, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

US (1)