Laparoscopic Surgery, Pneumoperitoneum, Post Operative Pain, Acute
Conditions
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.
Interventions
PROCEDURESmoke Evacuation Group
Active gas removal via smoke evacuator for 30 seconds at the end of case.
PROCEDURERecruitment Breath Group
Repeated pulmonary inflation maneuvers: Three (3) consecutive manual ventilations at maximum of 30 cm water at the end of case.
PROCEDUREControl Group
Passive desolation of the pneumoperitoneum at the end of the laparoscopic surgery.
Sponsors
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients age 18 to 65 * Benign, elective laparoscopic surgeries
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post operative pain | From enrollment until 1 week post surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
United States
Outcome results
None listed