Pain, Post-operativeNCT07631728
Does Trendelenburg Positioning During Pulmonary Recruitment Breaths Affect Post-laparoscopy Shoulder Pain
A study testing Pulmonary recruitment maneuver and Trendelenburg position in people with Pain, Post-operative and Pneumoperitoneum, run by Ankita Gupta.
Trial summary
The goal of this clinical trial is to evaluate whether different positioning in the operating room during removal of laparoscopic surgical gas differs in post-surgery shoulder pain. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Post-operative, Pneumoperitoneum, Urogynecologic Surgery
- What is being tested?
- Pulmonary recruitment maneuver and Trendelenburg position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to Nov 2027
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Robot-assisted laparoscopic surgery for benign gynecologic indication
- Surgery is booked for 60 minutes or longer
- Reliable working phone number or email
Who cannot join
- Patients with baseline opioid use
- Patients with existing shoulder or neck pain
- Active malignancy-related pain or surgery for malignant indication
- Concomitant upper abdominal or thoracic surgery
- Pre-existing emphysema, chronic obstructive pulmonary disease, or pneumothorax
- Non-English speaking
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Trendelenburg Positioning During Pulmonary Recruitment Breaths: A Randomized Controlled Trial
The goal of this clinical trial is to evaluate whether different positioning in the operating room during removal of laparoscopic surgical gas differs in post-surgery shoulder pain. An additional goal of this study is to evaluate whether positions change other post-surgery metrics such as bloating, time to passing gas, nausea and vomiting, and time to oral intake.
Researchers will compare Trendelenburg positioning where your head is tilted down to supine (level or flat) positioning during removal of surgical gas.
Participants will be asked to complete brief surveys at 24 and 72-hours post-surgery.
- Being tested
- Pulmonary recruitment maneuver, Trendelenburg position
- Keywords
- Trendelenburg, pneumoperitoneum, post-laparoscopy shoulder pain, post-laparoscopy pain, gynecologic surgery
- 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.
Pulmonary recruitment maneuverProcedure or surgery
Also called Pulmonary recruitment breaths, Valsalva breath
Active recruitment breaths delivered to patient by anesthesia provider as opposed to passive evacuation of pneumoperitoneum
Trendelenburg positionProcedure or surgery
Trendelenburg position as opposed to neutral (supine) position
| Study group | Role | What they receive |
|---|---|---|
| PRM Trendelenburg | Active comparator | PRM in Trendelenburg position (to 30 degrees or greatest degree patient can tolerate) with removal of tops of laparoscopic trocars Receives: Procedure: Pulmonary recruitment maneuver; Procedure: Trendelenburg position |
| PRM Supine | Active comparator | PRM in neutral position with removal of tops of laparoscopic trocars Receives: Procedure: Pulmonary recruitment maneuver |
| Passive Supine | No intervention | control group with passive evacuation of pneumoperitoneum: insufflation evacuation by removal of tops of laparoscopic trocars in neutral (supine) position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-laparoscopy shoulder pain, 24 hour VAS
Post-laparoscopy shoulder pain assessed on a visual analog scale zero to ten with zero representing no pain and ten representing the worst pain of their life.
Measured: 24 hours post-operatively
Secondary outcomes (10)
Post-laparoscopy shoulder pain, 72 hour VAS
Post-laparoscopy shoulder pain assessed on a visual analog scale zero to ten with zero representing no pain and ten representing the worst pain of their life.
Measured: 72-hours post-operatively
Pain Interference, 24 hour
Pain interference assessed by PROMIS Pain Interference Short Form 8a questionnaire. A raw score ranges from 8 (least problems with pain hindering activities) to 40 (most problems with pain hindering activities).
Measured: 24 hours post-operatively
Pain Interference, 72 hour
Pain interference assessed by PROMIS Pain Interference Short Form 8a questionnaire. A raw score ranges from 8 (least problems with pain hindering activities) to 40 (most problems with pain hindering activities).
Measured: 72 hours post-operatively
Total opioid use, 24 hr
total opioid use measured by MME
Measured: 24-hours postoperatively
Total opioid use, 72 hr
total opioid use at 72-hr postoperatively measured by total MME
Measured: 72-hours postoperatively
Time to flatus
Measured: up to 72-hours postoperatively
Nausea and Vomiting, 24 hour
Rhodes Index of Nausea Vomiting Retching is an 8-item questionnaire with scores ranging from 0 (no symptoms) to 32 (most severe symptoms).
Measured: 24 hours post-operatively
Nausea and Vomiting, 72 hour
Rhodes Index of Nausea Vomiting Retching is an 8-item questionnaire with scores ranging from 0 (no symptoms) to 32 (most severe symptoms).
Measured: 72 hours post-operatively
Gas & Bloating, 24 hour
Bloating measured by PROMIS Gas and Bloating 13a questionnaire. The raw summed score ranges from 3 (no symptoms) to 36 (worst reported symptoms).
Measured: 24 hours post-operatively
Gas & Bloating, 72 hour
Bloating measured by PROMIS Gas and Bloating 13a questionnaire. The raw summed score ranges from 3 (no symptoms) to 36 (worst reported symptoms).
Measured: 72 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pain, Post-operativeStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankita Gupta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ankita Gupta, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07631728
- Sponsor's protocol ID
- 25.0897
- Status last verified
- Jun 2026
- First submitted
- 1 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Berberoglu M, Dilek ON, Ercan F, Kati I, Ozmen M. The effect of CO2 insufflation rate on the postlaparoscopic shoulder pain. J Laparoendosc Adv Surg Tech A. 1998 Oct;8(5):273-7. doi: 10.1089/lap.1998.8.273.
PubMed 9820719Ryu K, Choi W, Shim J, Song T. The impact of a pulmonary recruitment maneuver to reduce post-laparoscopic shoulder pain: A randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2017 Jan;208:55-60. doi: 10.1016/j.ejogrb.2016.11.014. Epub 2016 Nov 16.
PubMed 27889667Kiyak H, Yilmaz G, Ay N. Semi-Fowler positioning in addition to the pulmonary recruitment manoeuvre reduces shoulder pain following gynaecologic laparoscopic surgery. Wideochir Inne Tech Maloinwazyjne. 2019 Dec;14(4):567-574. doi: 10.5114/wiitm.2019.84384. Epub 2019 Apr 11.
PubMed 31908704Phelps P, Cakmakkaya OS, Apfel CC, Radke OC. A simple clinical maneuver to reduce laparoscopy-induced shoulder pain: a randomized controlled trial. Obstet Gynecol. 2008 May;111(5):1155-60. doi: 10.1097/AOG.0b013e31816e34b4.
PubMed 18448749
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trendelenburg Positioning During Pulmonary Recruitment Breaths: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07631728
- Acronym / sponsor ID
- 25.0897
- Keywords
- Trendelenburg, pneumoperitoneum, post-laparoscopy shoulder pain, post-laparoscopy pain, gynecologic surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ankita GuptaUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 8 Jun 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.
The goal of this clinical trial is to evaluate whether different positioning in the operating room during removal of laparoscopic surgical gas differs in post-surgery shoulder pain. An additional goal of this study is to evaluate whether positions change other post-surgery metrics such as bloating, time to passing gas, nausea and vomiting, and time to oral intake.
Researchers will compare Trendelenburg positioning where your head is tilted down to supine (level or flat) positioning during removal of surgical gas.
Participants will be asked to complete brief surveys at 24 and 72-hours post-surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PRM Trendelenburg | Active comparator | Procedure: Pulmonary recruitment maneuver, Procedure: Trendelenburg positionPRM in Trendelenburg position (to 30 degrees or greatest degree patient can tolerate) with removal of tops of laparoscopic trocars |
| PRM Supine | Active comparator | Procedure: Pulmonary recruitment maneuverPRM in neutral position with removal of tops of laparoscopic trocars |
| Passive Supine | No intervention | –control group with passive evacuation of pneumoperitoneum: insufflation evacuation by removal of tops of laparoscopic trocars in neutral (supine) position |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Robot-assisted laparoscopic surgery for benign gynecologic indication
- Surgery is booked for 60 minutes or longer
- Reliable working phone number or email
Key exclusion criteria (6 listed)
- Patients with baseline opioid use
- Patients with existing shoulder or neck pain
- Active malignancy-related pain or surgery for malignant indication
- Concomitant upper abdominal or thoracic surgery
- Pre-existing emphysema, chronic obstructive pulmonary disease, or pneumothorax
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 |
|---|---|---|
| Pulmonary recruitment maneuverAlso: Pulmonary recruitment breaths, Valsalva breathActive recruitment breaths delivered to patient by anesthesia provider as opposed to passive evacuation of pneumoperitoneum | Procedure or surgery | PRM Supine, PRM Trendelenburg |
| Trendelenburg positionTrendelenburg position as opposed to neutral (supine) position | Procedure or surgery | PRM Trendelenburg |
Primary outcome
Post-laparoscopy shoulder pain, 24 hour VAS
Time frame: 24 hours post-operatively
Post-laparoscopy shoulder pain assessed on a visual analog scale zero to ten with zero representing no pain and ten representing the worst pain of their life.
10 secondary outcomes
Post-laparoscopy shoulder pain, 72 hour VAS
Time frame: 72-hours post-operatively
Pain Interference, 24 hour
Time frame: 24 hours post-operatively
Pain Interference, 72 hour
Time frame: 72 hours post-operatively
Total opioid use, 24 hr
Time frame: 24-hours postoperatively
Total opioid use, 72 hr
Time frame: 72-hours postoperatively
Time to flatus
Time frame: up to 72-hours postoperatively
Nausea and Vomiting, 24 hour
Time frame: 24 hours post-operatively
Nausea and Vomiting, 72 hour
Time frame: 72 hours post-operatively
Gas & Bloating, 24 hour
Time frame: 24 hours post-operatively
Gas & Bloating, 72 hour
Time frame: 72 hours post-operatively
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 8 Jun 2026.
- Background: PubMed 9820719Berberoglu M, Dilek ON, Ercan F, Kati I, Ozmen M. The effect of CO2 insufflation rate on the postlaparoscopic shoulder pain. J Laparoendosc Adv Surg Tech A. 1998 Oct;8(5):273-7. doi: 10.1089/lap.1998.8.273.
- Background: PubMed 27889667Ryu K, Choi W, Shim J, Song T. The impact of a pulmonary recruitment maneuver to reduce post-laparoscopic shoulder pain: A randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2017 Jan;208:55-60. doi: 10.1016/j.ejogrb.2016.11.014. Epub 2016 Nov 16.
- Background: PubMed 31908704Kiyak H, Yilmaz G, Ay N. Semi-Fowler positioning in addition to the pulmonary recruitment manoeuvre reduces shoulder pain following gynaecologic laparoscopic surgery. Wideochir Inne Tech Maloinwazyjne. 2019 Dec;14(4):567-574. doi: 10.5114/wiitm.2019.84384. Epub 2019 Apr 11.
- Background: PubMed 18448749Phelps P, Cakmakkaya OS, Apfel CC, Radke OC. A simple clinical maneuver to reduce laparoscopy-induced shoulder pain: a randomized controlled trial. Obstet Gynecol. 2008 May;111(5):1155-60. doi: 10.1097/AOG.0b013e31816e34b4.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary recruitment maneuver and Trendelenburg position in people with Pain, Post-operative and Pneumoperitoneum, run by Ankita Gupta.
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 3 inclusion and 6 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 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Contact Debbie Shim (502-561-7260, deborah.shim@louisville.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-laparoscopy shoulder pain, 24 hour VAS (time frame: 24 hours post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07631728, which also lists 4 linked publications.
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 8 Jun 2026.