Laparoscopic Surgery
Conditions
Keywords
laparoscopic surgery, insufflation, pneumoperitoneum, gynecologic surgery, postoperative pain, robotic surgery
Brief 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.
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: 1. Standard vs. Lower Pressure Pneumoperitoneum in Conventional Laparoscopic Gynecologic Surgery 2. Standard vs. Lower Pressure Pneumoperitoneum in Robotic-Assisted Laparoscopic Gynecologic Surgery. The methodology for the two arms will be otherwise identical.
Interventions
OTHERCarbon dioxide
Gas used for insufflation pressure
DRUGBupivacaine
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).
DRUGOxycodone
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.
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Patients and post-anesthesia care unit nurses will be masked.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum documented pain score in post-anesthesia care unit (PACU) (numerical rating scale, 0-10) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| First reported pain score in PACU (numerical rating scale, 0-10) | Immediately upon arrival to 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. |
| Last reported pain score in PACU prior to discharge (numerical rating scale, 0-10) | Immediately prior to 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. |
| Inpatient morphine milligram equivalents | Day of surgery (postoperative day 0) | Daily total of opioid medications administered on the day of surgery |
| 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 | Postoperatively, before discharge from PACU (postoperative day 0) | From arrival to PACU to discharge home |
| Surgeon-reported adequacy of assigned insufflation pressure | Immediately following surgery | 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 |
| Need for adjustment of insufflation pressure | Intraoperative | In a post-op questionnaire, surgeons will indicate whether the insufflation pressure was adjusted at any point during the procedure (yes/no). |
Countries
United States
Contacts
Primary ContactRebecca Schneyer, MD
Backup ContactRebekah Odum, BSN
Outcome results
None listed