Maneuvers to Reduce Laparoscopic Pain

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorHenry Ford Health System

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients age 18 to 65

Benign, elective laparoscopic surgeries

Disqualifiers

Ages <18 and age >65

Emergency or urgent surgeries

Surgeries for chronic pelvic pain, malignancy

Surgeries during pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Smoke Evacuation Group

    Procedure/Surgery

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

  • Recruitment Breath Group

    Procedure/Surgery

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

  • Control Group

    Procedure/Surgery

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

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Smoke Evacuation GroupExperimental treatment 1 intervention
Group B: Recruitment Breath GroupExperimental treatment 1 intervention
Group C: Control GroupPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
From enrollment until 1 week post surgery

Secondary outcomes

1

Opioid use for the management of post operative pain

Opioid use: Patients will be asked how many of the opioid pain medication pills they were discharged with were consumed, at either their 2-week post-operative in-person visit or phone call question. Patients will be instructed to either count the number of pills that were taken or bring the bottle to their visit.

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

Other outcomes

Sponsors and contacts

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