Laparoscopic SurgeryNCT07583433
Maneuvers to Reduce Laparoscopic Pain
A study testing Smoke Evacuation Group and Recruitment Breath Group in people with Laparoscopic Surgery and Post Operative Pain, Acute, run by Henry Ford Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Surgery, Post Operative Pain, Acute, Pneumoperitoneum
- What is being tested?
- Smoke Evacuation Group and Recruitment Breath Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients age 18 to 65
- Benign, elective laparoscopic surgeries
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Henry Ford Hospital
Detroit, Michigan, 48202
Ilinca Lupea, MD, 3134254567, ilupea1@hfhs.org
Ilinca Lupea, MD
About this study
Official title: 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 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.
Read more
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.
- Being tested
- Smoke Evacuation Group, Recruitment Breath Group, Control Group
- Medical subject headings
- Pain, Postoperative, Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoke Evacuation GroupProcedure or surgery
Active gas removal via smoke evacuator for 30 seconds at the end of case.
Recruitment Breath GroupProcedure or surgery
Repeated pulmonary inflation maneuvers: Three (3) consecutive manual ventilations at maximum of 30 cm water at the end of case.
Control GroupProcedure or surgery
Passive desolation of the pneumoperitoneum at the end of the laparoscopic surgery.
| Study group | Role | What they receive |
|---|---|---|
| Smoke Evacuation Group | Experimental | Not described Receives: Procedure: Smoke Evacuation Group |
| Recruitment Breath Group | Experimental | Not described Receives: Procedure: Recruitment Breath Group |
| Control Group | Placebo comparator | Not described Receives: Procedure: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Time of enrollment until their post operative appointment up to 2 weeks from the time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start1 Oct 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilinca Lupea, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07583433
- Sponsor's protocol ID
- 18542-01
- Status last verified
- Jun 2026
- First submitted
- 6 May 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Maneuver to Reduce Postoperative Pain Following Elective Laparoscopic Surgeries
- ClinicalTrials.gov ID
- NCT07583433
- Acronym / sponsor ID
- 18542-01
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Smoke Evacuation Group | Experimental | Procedure: Smoke Evacuation Group |
| Recruitment Breath Group | Experimental | Procedure: Recruitment Breath Group |
| Control Group | Placebo comparator | Procedure: Control Group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients age 18 to 65
- Benign, elective laparoscopic surgeries
Key exclusion criteria (7 listed)
- Ages <18 and age >65
- Emergency or urgent surgeries
- Surgeries for chronic pelvic pain, malignancy
- Surgeries during pregnancy
- Severe cardiopulmonary disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoke Evacuation GroupActive gas removal via smoke evacuator for 30 seconds at the end of case. | Procedure or surgery | Smoke Evacuation Group |
| Recruitment Breath GroupRepeated pulmonary inflation maneuvers: Three (3) consecutive manual ventilations at maximum of 30 cm water at the end of case. | Procedure or surgery | Recruitment Breath Group |
| Control GroupPassive desolation of the pneumoperitoneum at the end of the laparoscopic surgery. | Procedure or surgery | Control Group |
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoke Evacuation Group and Recruitment Breath Group in people with Laparoscopic Surgery and Post Operative Pain, Acute, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative pain (time frame: From enrollment until 1 week post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026; AzTrials last refreshed its copy on 27 Oct 2026.