- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07583433
Maneuvers to Reduce Laparoscopic Pain
Optimal Maneuver to Reduce Postoperative Pain Following Elective Laparoscopic Surgeries
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 use1-3. 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 pain4.
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 instillation5, pulmonary recruitment6,7, and gas aspiration via smoke evauator8.
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 reduction3,5,9.
Given the importance of minimizing postoperative pain, reducing opioid requirements, and shortening postoperative recovery time, we propose a prospective, patient-blinded, randomized controlled trial. We aim to investigate whether active gas removal via a smoke evacuator, multiple breath recruitment maneuvers, or no intervention would contribute to lowest postoperative pain. We hope our findings will help identify the most effective method for reducing residual pneumoperitoneum-related pain and thus inform surgical practices and improve patient outcomes.
Study Overview
Status
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States, 48202
- Henry Ford Hospital
-
Contact:
- Ilinca Lupea, MD
- Phone Number: 3134254567
- Email: ilupea1@hfhs.org
-
Principal Investigator:
- Ilinca Lupea, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Smoke Evacuation Group
Active gas removal via smoke evacuator for 30 seconds at the end of case
|
the importance of minimizing postoperative pain, reducing opioid requirements, and shortening postoperative recovery time, we propose a prospective, patient-blinded, randomized controlled trial.
We aim to investigate whether active gas removal via a smoke evacuator, multiple breath recruitment maneuvers, or no intervention would contribute to lowest postoperative pain.
We hope our findings will help identify the most effective method for reducing residual pneumoperitoneum-related pain and thus inform surgical practices and improve patient outcomes.
|
|
Experimental: Recruitment Breath Group
Repeated pulmonary inflation maneuvers: 3 consecutive manual ventilations at maximum of 30 cm H2O at the end of case
|
the importance of minimizing postoperative pain, reducing opioid requirements, and shortening postoperative recovery time, we propose a prospective, patient-blinded, randomized controlled trial.
We aim to investigate whether active gas removal via a smoke evacuator, multiple breath recruitment maneuvers, or no intervention would contribute to lowest postoperative pain.
We hope our findings will help identify the most effective method for reducing residual pneumoperitoneum-related pain and thus inform surgical practices and improve patient outcomes.
|
|
Placebo Comparator: Control Group
Passive desolation of the pneumoperitoneum at the end of the laparoscopic surgery
|
the importance of minimizing postoperative pain, reducing opioid requirements, and shortening postoperative recovery time, we propose a prospective, patient-blinded, randomized controlled trial.
We aim to investigate whether active gas removal via a smoke evacuator, multiple breath recruitment maneuvers, or no intervention would contribute to lowest postoperative pain.
We hope our findings will help identify the most effective method for reducing residual pneumoperitoneum-related pain and thus inform surgical practices and improve patient outcomes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post operative pain
Time Frame: 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.
|
From enrollment until 1 week post surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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 of enrollment until their post operative appointment up to 2 weeks from the time of surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18542-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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