Postoperative Pain ScoreNCT06990750
Single Port Insufflation RCT
A study testing 15 mmHg and 12 mmHg in people with Postoperative Pain Score, run by University of Chicago at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if decreasing insufflation pressure during minimally invasive single port robotic sacrocolpopexy improved postoperative pain without impacting surgeon intraoperative visualization. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Pain Score
- What is being tested?
- 15 mmHg and 12 mmHg
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult women scheduled for single port robotic sacrocolpopexy for uterovaginal or vaginal vault prolapse
Who cannot join
- Non-english speaking
- Inability to complete study questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Insufflation Pressure and Postoperative Pain After Single Port Robotic Sacrocolpopexy
The goal of this clinical trial is to learn if decreasing insufflation pressure during minimally invasive single port robotic sacrocolpopexy improved postoperative pain without impacting surgeon intraoperative visualization. The main question it aims to answer is:
Does minimally decreasing insufflation pressure improve postoperative pain?
Read more
Researchers will compare standard insufflation pressure (15 mmHg) to experimental insufflation pressure (12 mmHg) to see if it insufflation pressure impacts patient's postoperative pain.
Once a participants agrees to participate in our study, they will receive either standard or experimental pressure at the time of surgery. Postoperative pain scores in the postoperative anesthesia care unit and at postoperative day 1 and 14 visits will be recorded. Participants will also be asked to complete the Patient Global Impression of Improvement at the 14 day visit.
Read the detailed description
This was a double-blinded, randomized control trial of women undergoing single port robotic sacrocolpopexy with intraperitoneal insufflation pressure set to 15 mm Hg (standard pressure) or 12 mm Hg (experimental pressure). Participants were randomized in a 1:1 ratio. Randomization was performed by an unblinded research coordinator with stratification by concomitant hysterectomy. Robotic surgeries were performed with the DaVinci single port robotic system, which supports the use of an 8-mm AirSeal port. Preoperative pain score (2 hours prior to surgery) were documented by a member of the research team. The operating room circulating nurse set the insufflation pressure to either 12 or 15 mm Hg depending on randomization. Both the patient and surgeon were blinded to the insufflation pressure. In post anesthesia care unit , patient reported pain scores were documented by nursing staff. Median immediate postoperative pain score and total required morphine milligram equivalents (MME) were recorded. On postop day one, participants were be asked to rate their pain with a numeric rating scale by a registered nurse. At 2 weeks postoperatively, participants were asked to rate their pain with a numeric rating scale and completed the Patient Global Impression of Improvement. At both visits, the clinical team member asked the patient how many narcotic tablets they have left to calculate total MME use outpatient. The clinical team member conducting these visits was blinded to randomization groups. Pain scores and patient responses were collected as well as demographics, clinical characteristics, surgery details, intraoperative outcomes, and 2 week postoperative outcomes. The investigators estimate the median numeric rating scale score in the immediate postoperative period to be 75 mm in the standard insufflation pressure group based on prior literature. The investigators calculated that 32 patients in each group are needed to detect a significant improvement of median numeric rating scale score to 60 mm in the experimental group. The investigators planned to enroll at least 64 participants to have 80% power to detect a 15 mm difference in scores between the two groups assuming a two-sided significance level of 5%. Assuming a 10% drop out rate, a total sample of 70 participants was recruited.
- Conditions
- Postoperative Pain Score
- Being tested
- 15 mmHg, 12 mmHg
- Keywords
- insufflation pressure, postoperative pain, surgeon visualization, robotic sacrocolpopexy, single port sacrocolpopexy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
15 mmHgProcedure or surgery
Also called Standard insufflation pressure
Insufflation pressure was set to 15 mm Hg at the time of single port robotic sacrocolpopexy.
12 mmHgProcedure or surgery
Also called Experimental insufflation pressure
Insufflation pressure was set to 12 mm Hg at the time of single port robotic sacrocolpopexy.
| Study group | Role | What they receive |
|---|---|---|
| Standard pressure | Active comparator | Insufflation pressure set to 15 mmHg (standard pressure). Receives: Procedure: 15 mmHg |
| Experimental Pressure | Experimental | Insufflation pressure set to 12 mm Hg (experimental pressure) Receives: Procedure: 12 mmHg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post anesthesia Care Unit Pain
Immediate after surgery in the post anesthesia care unit (PACU), patients were asked to rate their pain using a 100 point numeric rating scale (0 [no pain] to 100 [worst imaginable pain]). The PACU nurse routine asked pain score with routine vitals. The median score was recorded.
Measured: 0 mins-4 hours after surgery
Secondary outcomes (6)
Post anesthesia care unit morphine milligram equivalents
The total amount of morphine milligram equivalents the patient received in PACU was recorded.
Measured: 0 mins-4 hours
Postoperative day one pain
On postoperative day one telephone call, patients were asked to rate their pain using a 100 point numeric rating scale (0 [no pain] to 100 [worst imaginable pain]) by the clinical team member.
Measured: 24 hours after surgery
Postoperative day one morphine milligram equivalents
On postoperative day one telephone call, patients were asked how many tablets of narcotics they had taken since discharge. Morphine milligram equivalents was then recorded.
Measured: 24 hours after surgery
Postoperative day 14 pain
At postoperative day 14 telemedicine visit, patients were asked to rate their pain using a 100 point numeric rating scale (0 [no pain] to 100 [worst imaginable pain]) by the clinical team member.
Measured: 14 days after surgery
Postoperative day 14 morphine milligram equivalents
At postoperative day 14 telemedicine visit, patients were asked how many tablets of narcotics they had taken since discharge. Morphine milligram equivalents was then recorded.
Measured: 14 days after surgery
Patient Global Impression of Improvement
At postoperative day 14 telemedicine visit, the patients were asked to complete the Patient Global Impression of Improvement (1 [very much improved] to 7 [very much worse]). Answers were recorded.
Measured: 14 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start1 Apr 2024
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pain ScoreStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margaret G Mueller, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06990750
- Sponsor's protocol ID
- IRB23-1711
- Status last verified
- Feb 2026
- First submitted
- 16 May 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ashmore S, Burgard I, Russo D, Kenton K, Lewicky-Gaupp C, Collins SA, Mueller MG. Insufflation Pressure and Pain After Single-Port Robotic Sacrocolpopexy. Urogynecology (Phila). 2026 Apr 1;32(4):430-437. doi: 10.1097/SPV.0000000000001814.
PubMed 41854467
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insufflation Pressure and Postoperative Pain After Single Port Robotic Sacrocolpopexy
- ClinicalTrials.gov ID
- NCT06990750
- Acronym / sponsor ID
- IRB23-1711
- Conditions
- Postoperative Pain Score
- Keywords
- insufflation pressure, postoperative pain, surgeon visualization, robotic sacrocolpopexy, single port sacrocolpopexy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 25 May 2025 (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 learn if decreasing insufflation pressure during minimally invasive single port robotic sacrocolpopexy improved postoperative pain without impacting surgeon intraoperative visualization. The main question it aims to answer is:
Does minimally decreasing insufflation pressure improve postoperative pain?
Researchers will compare standard insufflation pressure (15 mmHg) to experimental insufflation pressure (12 mmHg) to see if it insufflation pressure impacts patient's postoperative pain.
Once a participants agrees to participate in our study, they will receive either standard or experimental pressure at the time of surgery. Postoperative pain scores in the postoperative anesthesia care unit and at postoperative day 1 and 14 visits will be recorded. Participants will also be asked to complete the Patient Global Impression of Improvement at the 14 day visit.
Detailed description
This was a double-blinded, randomized control trial of women undergoing single port robotic sacrocolpopexy with intraperitoneal insufflation pressure set to 15 mm Hg (standard pressure) or 12 mm Hg (experimental pressure). Participants were randomized in a 1:1 ratio. Randomization was performed by an unblinded research coordinator with stratification by concomitant hysterectomy. Robotic surgeries were performed with the DaVinci single port robotic system, which supports the use of an 8-mm AirSeal port. Preoperative pain score (2 hours prior to surgery) were documented by a member of the research team. The operating room circulating nurse set the insufflation pressure to either 12 or 15 mm Hg depending on randomization. Both the patient and surgeon were blinded to the insufflation pressure. In post anesthesia care unit , patient reported pain scores were documented by nursing staff. Median immediate postoperative pain score and total required morphine milligram equivalents (MME) were recorded. On postop day one, participants were be asked to rate their pain with a numeric rating scale by a registered nurse. At 2 weeks postoperatively, participants were asked to rate their pain with a numeric rating scale and completed the Patient Global Impression of Improvement. At both visits, the clinical team member asked the patient how many narcotic tablets they have left to calculate total MME use outpatient. The clinical team member conducting these visits was blinded to randomization groups. Pain scores and patient responses were collected as well as demographics, clinical characteristics, surgery details, intraoperative outcomes, and 2 week postoperative outcomes. The investigators estimate the median numeric rating scale score in the immediate postoperative period to be 75 mm in the standard insufflation pressure group based on prior literature. The investigators calculated that 32 patients in each group are needed to detect a significant improvement of median numeric rating scale score to 60 mm in the experimental group. The investigators planned to enroll at least 64 participants to have 80% power to detect a 15 mm difference in scores between the two groups assuming a two-sided significance level of 5%. Assuming a 10% drop out rate, a total sample of 70 participants was recruited.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard pressure | Active comparator | Procedure: 15 mmHgInsufflation pressure set to 15 mmHg (standard pressure). |
| Experimental Pressure | Experimental | Procedure: 12 mmHgInsufflation pressure set to 12 mm Hg (experimental pressure) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult women scheduled for single port robotic sacrocolpopexy for uterovaginal or vaginal vault prolapse
Key exclusion criteria (2 listed)
- Non-english speaking
- Inability to complete study questionnaires
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 |
|---|---|---|
| 15 mmHgAlso: Standard insufflation pressureInsufflation pressure was set to 15 mm Hg at the time of single port robotic sacrocolpopexy. | Procedure or surgery | Standard pressure |
| 12 mmHgAlso: Experimental insufflation pressureInsufflation pressure was set to 12 mm Hg at the time of single port robotic sacrocolpopexy. | Procedure or surgery | Experimental Pressure |
Primary outcome
Post anesthesia Care Unit Pain
Time frame: 0 mins-4 hours after surgery
Immediate after surgery in the post anesthesia care unit (PACU), patients were asked to rate their pain using a 100 point numeric rating scale (0 [no pain] to 100 [worst imaginable pain]). The PACU nurse routine asked pain score with routine vitals. The median score was recorded.
6 secondary outcomes
Post anesthesia care unit morphine milligram equivalents
Time frame: 0 mins-4 hours
Postoperative day one pain
Time frame: 24 hours after surgery
Postoperative day one morphine milligram equivalents
Time frame: 24 hours after surgery
Postoperative day 14 pain
Time frame: 14 days after surgery
Postoperative day 14 morphine milligram equivalents
Time frame: 14 days after surgery
Patient Global Impression of Improvement
Time frame: 14 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Derived from this study: PubMed 41854467Ashmore S, Burgard I, Russo D, Kenton K, Lewicky-Gaupp C, Collins SA, Mueller MG. Insufflation Pressure and Pain After Single-Port Robotic Sacrocolpopexy. Urogynecology (Phila). 2026 Apr 1;32(4):430-437. doi: 10.1097/SPV.0000000000001814.
- 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. This study is not recruiting at the moment.
Margaret G Mueller, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 15 mmHg and 12 mmHg in people with Postoperative Pain Score, run by University of Chicago 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 6 Feb 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post anesthesia Care Unit Pain (time frame: 0 mins-4 hours after surgery). 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 NCT06990750, which also lists 1 linked publication.
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 6 Feb 2026.