Laparoscopic SurgeryNCT06338865
Short Title: Standard vs. Lower Pressure Pneumoperitoneum
A study testing Carbon dioxide, Bupivacaine and Oxycodone in people with Laparoscopic Surgery, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
This study aims to investigate the effect of varying insufflation pressures on post-operative pain and adequacy of surgical field visualization among patients undergoing laparoscopic surgery with a minimally invasive gynecologic surgeon. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Laparoscopic Surgery
- What is being tested?
- Carbon dioxide, Bupivacaine and Oxycodone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2024to Apr 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- 18 years of age or older
- Undergoing laparoscopic surgery at Cedars-Sinai Medical Center with a surgeon in the Minimally Invasive Gynecologic Surgery division.
Who cannot join
- Pregnancy
- Urgent/non-scheduled surgery
- Scheduled for planned or possible concomitant non-gynecologic surgery (e.g., urologic or colorectal procedure)
- Baseline opioid use
- Allergy or intolerance to bupivacaine (or amide class of anesthetics), oxycodone, acetaminophen, or ibuprofen
- Planned post-operative admission
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rebekah Odum, BSN contact
United States1 site, 1 recruiting
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Rebecca Schneyer, MD, 914-391-2604, rebecca.schneyer@cshs.org
About this study
Official title: Standard vs. Lower Pressure Pneumoperitoneum in Laparoscopic Gynecologic Surgery: A Randomized Controlled Trial
This study aims to investigate the effect of varying insufflation pressures on post-operative pain and adequacy of surgical field visualization among patients undergoing laparoscopic surgery with a minimally invasive gynecologic surgeon.
Read the detailed description
This will be a single-center, single-blinded randomized controlled trial evaluating the impact of lower pressure pneumoperitoneum on post-operative pain and surgical field visualization among patients undergoing laparoscopic gynecologic surgery. The investigators hypothesize that lower insufflation pressures will decrease post-operative pain in the immediate post-operative period without compromising surgical field visualization. The study will include 3 groups corresponding to varying insufflation pressures: 15mmHg (standard), 12mmHg and 10mmHg. Participants will be 1:1:1 allocated to the 15mmHg, 12mmHg or 10mmHg groups (parallel design) by block randomization.
Given inherent differences in how pneumoperitoneum is maintained during conventional versus robotic-assisted laparoscopic surgery, the investigators will be enrolling patients in two separate arms depending on their planned procedure:
- Standard vs. Lower Pressure Pneumoperitoneum in Conventional Laparoscopic Gynecologic Surgery
- Standard vs. Lower Pressure Pneumoperitoneum in Robotic-Assisted Laparoscopic Gynecologic Surgery.
The methodology for the two arms will be otherwise identical.
- Conditions
- Laparoscopic Surgery
- Being tested
- Carbon dioxide, Bupivacaine, Oxycodone
- Keywords
- laparoscopic surgery, insufflation, pneumoperitoneum, gynecologic surgery, postoperative pain, robotic surgery
- Medical subject headings
- Pneumoperitoneum, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon dioxideOther
Gas used for insufflation pressure
BupivacaineDrug
Local subcutaneous infiltration of all port sites with 0.25% bupivacaine will be performed prior to each incision. Remaining local anesthetic will be administered into the incision sites prior to the conclusion of the case (30cc total).
OxycodoneDrug
All patients will be prescribed a total of 10 pills of oxycodone 5mg, which is the standard amount that our practice prescribes for patients after laparoscopic surgery.
| Study group | Role | What they receive |
|---|---|---|
| 15mmHg (Conventional Laparoscopic Arm) | Active comparator | Standard Pressure, Conventional Laparoscopic Arm Receives: Other: Carbon dioxide; Drug: Bupivacaine; Drug: Oxycodone |
| 12mmHg (Conventional Laparoscopic Arm) | Experimental | Lower Pressure, Conventional Laparoscopic Arm Receives: Other: Carbon dioxide; Drug: Bupivacaine; Drug: Oxycodone |
| 10mmHg (Conventional Laparoscopic Arm) | Experimental | Lowest Pressure, Conventional Laparoscopic Arm Receives: Other: Carbon dioxide; Drug: Bupivacaine; Drug: Oxycodone |
| 15mmHg (Robotic-Assisted Laparoscopic Arm) | Active comparator | Standard Pressure, Robotic-Assisted Laparoscopic Arm Receives: Other: Carbon dioxide; Drug: Bupivacaine; Drug: Oxycodone |
| 12mmHg (Robotic-Assisted Laparoscopic Arm) | Experimental | Lower Pressure, Robotic-Assisted Laparoscopic Arm Receives: Other: Carbon dioxide; Drug: Bupivacaine; Drug: Oxycodone |
| 10mmHg (Robotic-Assisted Laparoscopic Arm) | Experimental | Lowest Pressure, Robotic-Assisted Laparoscopic Arm Receives: Other: Carbon dioxide; Drug: Bupivacaine; Drug: Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum documented pain score in post-anesthesia care unit (PACU) (numerical rating scale, 0-10)
The numerical rating scale is a pain screening tool that is routinely used to assess pain severity in the postoperative setting using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable."
Measured: Postoperatively, before discharge from PACU (postoperative day 0)
Secondary outcomes (12)
First reported pain score in PACU (numerical rating scale, 0-10)
The numerical rating scale is a pain screening tool that is routinely used to assess pain severity in the postoperative setting using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable."
Measured: Immediately upon arrival to PACU (postoperative day 0)
Last reported pain score in PACU prior to discharge (numerical rating scale, 0-10)
The numerical rating scale is a pain screening tool that is routinely used to assess pain severity in the postoperative setting using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable."
Measured: Immediately prior to discharge from PACU (postoperative day 0)
Inpatient morphine milligram equivalents
Daily total of opioid medications administered on the day of surgery
Measured: Day of surgery (postoperative day 0)
Total number of 5mg oxycodone pills taken in the 2 weeks following discharge
Measured: Assessed at postoperative day 14
Need for insufflation pressure increase intra-operatively due to inadequate visualization
Measured: Intraoperative
Operative time
Measured: Intraoperative
Estimated blood loss
Measured: Intraoperative
Intraoperative complications
Measured: Intraoperative
Conversion to laparotomy
Measured: Intraoperative
Postoperative length of stay
From arrival to PACU to discharge home
Measured: Postoperatively, before discharge from PACU (postoperative day 0)
Surgeon-reported adequacy of assigned insufflation pressure
Surgeons will rate their agreement with the following statement on a 5-point Likert scale (from strongly disagree to strongly agree): "The assigned insufflation pressure was adequate for this procedure"
Measured: Immediately following surgery
Need for adjustment of insufflation pressure
In a post-op questionnaire, surgeons will indicate whether the insufflation pressure was adjusted at any point during the procedure (yes/no).
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start3 May 2024
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 294 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Siedhoff, MD MSCR, Cedars-Sinai Medical Center
- Investigators
- Matthew Siedhoff, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338865
- Sponsor's protocol ID
- Study00003146
- Status last verified
- May 2024
- First submitted
- 21 Mar 2024
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard vs. Lower Pressure Pneumoperitoneum in Laparoscopic Gynecologic Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06338865
- Acronym / sponsor ID
- Study00003146
- Conditions
- Laparoscopic Surgery
- Keywords
- laparoscopic surgery, insufflation, pneumoperitoneum, gynecologic surgery, postoperative pain, robotic surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 294 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 3 May 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 1 Apr 2024 (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.
This study aims to investigate the effect of varying insufflation pressures on post-operative pain and adequacy of surgical field visualization among patients undergoing laparoscopic surgery with a minimally invasive gynecologic surgeon.
Detailed description
This will be a single-center, single-blinded randomized controlled trial evaluating the impact of lower pressure pneumoperitoneum on post-operative pain and surgical field visualization among patients undergoing laparoscopic gynecologic surgery. The investigators hypothesize that lower insufflation pressures will decrease post-operative pain in the immediate post-operative period without compromising surgical field visualization. The study will include 3 groups corresponding to varying insufflation pressures: 15mmHg (standard), 12mmHg and 10mmHg. Participants will be 1:1:1 allocated to the 15mmHg, 12mmHg or 10mmHg groups (parallel design) by block randomization.
Given inherent differences in how pneumoperitoneum is maintained during conventional versus robotic-assisted laparoscopic surgery, the investigators will be enrolling patients in two separate arms depending on their planned procedure:
- Standard vs. Lower Pressure Pneumoperitoneum in Conventional Laparoscopic Gynecologic Surgery
- Standard vs. Lower Pressure Pneumoperitoneum in Robotic-Assisted Laparoscopic Gynecologic Surgery.
The methodology for the two arms will be otherwise identical.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 15mmHg (Conventional Laparoscopic Arm) | Active comparator | Other: Carbon dioxide, Drug: Bupivacaine, Drug: OxycodoneStandard Pressure, Conventional Laparoscopic Arm |
| 12mmHg (Conventional Laparoscopic Arm) | Experimental | Other: Carbon dioxide, Drug: Bupivacaine, Drug: OxycodoneLower Pressure, Conventional Laparoscopic Arm |
| 10mmHg (Conventional Laparoscopic Arm) | Experimental | Other: Carbon dioxide, Drug: Bupivacaine, Drug: OxycodoneLowest Pressure, Conventional Laparoscopic Arm |
| 15mmHg (Robotic-Assisted Laparoscopic Arm) | Active comparator | Other: Carbon dioxide, Drug: Bupivacaine, Drug: OxycodoneStandard Pressure, Robotic-Assisted Laparoscopic Arm |
| 12mmHg (Robotic-Assisted Laparoscopic Arm) | Experimental | Other: Carbon dioxide, Drug: Bupivacaine, Drug: OxycodoneLower Pressure, Robotic-Assisted Laparoscopic Arm |
| 10mmHg (Robotic-Assisted Laparoscopic Arm) | Experimental | Other: Carbon dioxide, Drug: Bupivacaine, Drug: OxycodoneLowest Pressure, Robotic-Assisted Laparoscopic Arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- 18 years of age or older
- Undergoing laparoscopic surgery at Cedars-Sinai Medical Center with a surgeon in the Minimally Invasive Gynecologic Surgery division.
Key exclusion criteria (6 listed)
- Pregnancy
- Urgent/non-scheduled surgery
- Scheduled for planned or possible concomitant non-gynecologic surgery (e.g., urologic or colorectal procedure)
- Baseline opioid use
- Allergy or intolerance to bupivacaine (or amide class of anesthetics), oxycodone, acetaminophen, or ibuprofen
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 |
|---|---|---|
| Carbon dioxideGas used for insufflation pressure | Other | 10mmHg (Conventional Laparoscopic Arm), 10mmHg (Robotic-Assisted Laparoscopic Arm), 12mmHg (Conventional Laparoscopic Arm), 12mmHg (Robotic-Assisted Laparoscopic Arm), 15mmHg (Conventional Laparoscopic Arm), 15mmHg (Robotic-Assisted Laparoscopic Arm) |
| BupivacaineLocal subcutaneous infiltration of all port sites with 0.25% bupivacaine will be performed prior to each incision. Remaining local anesthetic will be administered into the incision sites prior to the conclusion of the case (30cc total). | Drug | 10mmHg (Conventional Laparoscopic Arm), 10mmHg (Robotic-Assisted Laparoscopic Arm), 12mmHg (Conventional Laparoscopic Arm), 12mmHg (Robotic-Assisted Laparoscopic Arm), 15mmHg (Conventional Laparoscopic Arm), 15mmHg (Robotic-Assisted Laparoscopic Arm) |
| OxycodoneAll patients will be prescribed a total of 10 pills of oxycodone 5mg, which is the standard amount that our practice prescribes for patients after laparoscopic surgery. | Drug | 10mmHg (Conventional Laparoscopic Arm), 10mmHg (Robotic-Assisted Laparoscopic Arm), 12mmHg (Conventional Laparoscopic Arm), 12mmHg (Robotic-Assisted Laparoscopic Arm), 15mmHg (Conventional Laparoscopic Arm), 15mmHg (Robotic-Assisted Laparoscopic Arm) |
Primary outcome
Maximum documented pain score in post-anesthesia care unit (PACU) (numerical rating scale, 0-10)
Time frame: Postoperatively, before discharge from PACU (postoperative day 0)
The numerical rating scale is a pain screening tool that is routinely used to assess pain severity in the postoperative setting using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable."
12 secondary outcomes
First reported pain score in PACU (numerical rating scale, 0-10)
Time frame: Immediately upon arrival to PACU (postoperative day 0)
Last reported pain score in PACU prior to discharge (numerical rating scale, 0-10)
Time frame: Immediately prior to discharge from PACU (postoperative day 0)
Inpatient morphine milligram equivalents
Time frame: Day of surgery (postoperative day 0)
Total number of 5mg oxycodone pills taken in the 2 weeks following discharge
Time frame: Assessed at postoperative day 14
Need for insufflation pressure increase intra-operatively due to inadequate visualization
Time frame: Intraoperative
Operative time
Time frame: Intraoperative
Estimated blood loss
Time frame: Intraoperative
Intraoperative complications
Time frame: Intraoperative
Conversion to laparotomy
Time frame: Intraoperative
Postoperative length of stay
Time frame: Postoperatively, before discharge from PACU (postoperative day 0)
Surgeon-reported adequacy of assigned insufflation pressure
Time frame: Immediately following surgery
Need for adjustment of insufflation pressure
Time frame: Intraoperative
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 10 May 2024.
- 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.
Rebekah Odum, BSN contact
Matthew Siedhoff, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbon dioxide, Bupivacaine and Oxycodone in people with Laparoscopic Surgery, run by Cedars-Sinai Medical Center 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 4 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: looking for participants now, as of the sponsor's last update on 10 May 2024. 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?
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 Rebecca Schneyer, MD (914-391-2604, rebecca.schneyer@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum documented pain score in post-anesthesia care unit (PACU) (numerical rating scale, 0-10) (time frame: Postoperatively, before discharge from PACU (postoperative day 0)). 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 10 May 2024.