Maneuvers to Reduce Laparoscopic Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Smoke Evacuation Group, Recruitment Breath Group, Control Group.
- Who it may be relevant to
- Registry conditions: Laparoscopic Surgery, Post Operative Pain, Acute, Pneumoperitoneum. Basic parameters: 18 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Optimal Maneuver to Reduce Postoperative Pain Following Elective Laparoscopic Surgeries
Overview
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
- Procedure Smoke Evacuation Group
Active gas removal via smoke evacuator for 30 seconds at the end of case. - Procedure Recruitment Breath Group
Repeated pulmonary inflation maneuvers: Three (3) consecutive manual ventilations at maximum of 30 cm water at the end of case. - Procedure Control Group
Passive desolation of the pneumoperitoneum at the end of the laparoscopic surgery.
Primary outcome measures
- Post operative pain [Time frame: From enrollment until 1 week post surgery]
Secondary outcome measures (1)
- Opioid use for the management of post operative pain [Time frame: Time of enrollment until their post operative appointment up to 2 weeks from the time of surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Henry Ford Hospital — Detroit
Identifiers
NCT: NCT07583433 · 18542-01