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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.
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:
The methodology for the two arms will be otherwise identical.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 15mmHg (Conventional Laparoscopic Arm) | Active Comparator | Standard Pressure, Conventional Laparoscopic Arm |
|
| 12mmHg (Conventional Laparoscopic Arm) | Experimental | Lower Pressure, Conventional Laparoscopic Arm |
|
| 10mmHg (Conventional Laparoscopic Arm) | Experimental | Lowest Pressure, Conventional Laparoscopic Arm |
|
| 15mmHg (Robotic-Assisted Laparoscopic Arm) | Active Comparator | Standard Pressure, Robotic-Assisted Laparoscopic Arm |
|
| 12mmHg (Robotic-Assisted Laparoscopic Arm) | Experimental | Lower Pressure, Robotic-Assisted Laparoscopic Arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbon dioxide | Other | Gas used for insufflation pressure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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." | Postoperatively, before discharge from PACU (postoperative day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| 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." | Immediately upon arrival to PACU (postoperative day 0) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Schneyer, MD | Contact | 914-391-2604 | rebecca.schneyer@cshs.org | |
| Rebekah Odum, BSN | Contact | rebekah.odum@cshs.org |
| Name | Affiliation | Role |
|---|---|---|
| Matthew Siedhoff, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Recruiting | Los Angeles | California | 90048 | United States |
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| ID | Term |
|---|---|
| D011027 | Pneumoperitoneum |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010532 | Peritoneal Diseases |
| D004066 | Digestive System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D002245 | Carbon Dioxide |
| D002045 | Bupivacaine |
| D010098 | Oxycodone |
| ID | Term |
|---|---|
| D017554 | Carbon Compounds, Inorganic |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
| D010087 | Oxides |
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Patients and post-anesthesia care unit nurses will be masked.
| 10mmHg (Robotic-Assisted Laparoscopic Arm) | Experimental | Lowest Pressure, Robotic-Assisted Laparoscopic Arm |
|
| Bupivacaine | Drug | 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). |
|
| Oxycodone | Drug | 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. |
|
| 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." |
| Immediately prior to discharge from PACU (postoperative day 0) |
| Inpatient morphine milligram equivalents | Daily total of opioid medications administered on the day of surgery | Day of surgery (postoperative day 0) |
| Total number of 5mg oxycodone pills taken in the 2 weeks following discharge | Assessed at postoperative day 14 |
| Need for insufflation pressure increase intra-operatively due to inadequate visualization | Intraoperative |
| Operative time | Intraoperative |
| Estimated blood loss | Intraoperative |
| Intraoperative complications | Intraoperative |
| Conversion to laparotomy | Intraoperative |
| Postoperative length of stay | From arrival to PACU to discharge home | 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" | 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). | Intraoperative |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D017601 |
| Oxygen Compounds |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |