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The goal of this clinical trial is to learn if the level of intra-abdominal pressure during benign gynecologic laparoscopic surgery impacts postoperative pain.
The main question it aims to answer is:
• Does use of low (8 mmHg) versus standard (15 mmHg) intra-abdominal pressure impact postoperative pain?
Researchers will compare the use of low (8 mmHg) versus standard (15 mmHg) intra-abdominal pressure.
Participants will:
Participants will be randomized into one of two experimental groups using a computer-generated allocation list: a low-pressure group (8 mmHg) or a standard-pressure group (15 mmHg). As part of standard care, many surgeons more often use 15 mmHg which is why this is named as our standard-pressure group. Some surgeons use low-pressure varying from 8 mmHg through 12 mmHg which is why our 8 mmHg is named the low-pressure group. The 8 mmHg is the most common acceptable low-pressure approach reported in the surgical literature. All surgeries will begin with standard insufflation at 15 mmHg to achieve safe abdominal access. Once the operative field is established, if necessary, the pressure will be adjusted according to the assigned group. For those surgeons who use 8 mmHg, standard care is to start at 15 mmHg and then to adjust to the lower pressure of 8 mmHg. Our proposed approach is consistent with standard clinical protocol. General anesthesia will be administered per institutional protocol, and local anesthetic will be applied to all trocar sites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard-pressure group | Active Comparator | 15 mmHg pressure |
|
| low-pressure group | Experimental | 8 mmHg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| abdominal pressure | Procedure | type of intra-abdominal pressure of either standard or low pressure |
|
| Measure | Description | Time Frame |
|---|---|---|
| PAIN OUT questionnaire | Self-report questionnaire to patient participants focusing on shoulder pain with a total composite score from 12 items. Minimum score is 0 and maximum score is 120. Higher scores indicate greater pain levels. | Perioperative/Periprocedural: Three hours after surgery completed |
| Measure | Description | Time Frame |
|---|---|---|
| PAIN OUT questionnaire | Self-report questionnaire to patient participants focusing on shoulder pain with a total composite score from 12 items. Minimum score is 0 and maximum score is 120. Higher scores indicate greater pain levels. | Perioperative/Periprocedural: 24 hours after surgery completed |
| Numerical rating scale for pain location in the abdomen |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Petr Itzhak, DO | Contact | 516-296-7394 | pitzhak@numc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Petr Itzhak, DO | Nassau University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nassau University Medical Center | East Meadow | New York | 11554 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37026807 | Background | Reijnders-Boerboom GTJA, Albers KI, Jacobs LMC, Helden EV, Rosman C, Diaz-Cambronero O, Mazzinari G, Scheffer GJ, Keijzer C, Warle MC. Low intra-abdominal pressure in laparoscopic surgery: a systematic review and meta-analysis. Int J Surg. 2023 May 1;109(5):1400-1411. doi: 10.1097/JS9.0000000000000289. |
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Deidentfied data based upon a reasonable request
After study using data is published
Academic researchers
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008150 | Lower Body Negative Pressure |
| ID | Term |
|---|---|
| D003664 | Decompression |
| D013812 | Therapeutics |
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One item to patient participants to rate the abdominal pain from 0 (no pain) to 10 (worst pain) |
| Perioperative/Periprocedural: One hour after surgery |
| Numerical rating scale for pain location in the shoulder | One item to patient participants to rate the shoulder pain from 0 (no pain) to 10 (worst pain) | Perioperative/Periprocedural: One hour after surgery |
| Visual analog scale for pain location in the abdomen | One item to patient participants to rate the abdominal pain from 0 (no pain) to 10 (worst pain) | Perioperative/Periprocedural: Three hours after surgery completed |
| Visual analog scale for pain location in the abdomen | One item to patient participants to rate the abdominal pain from 0 (no pain) to 10 (worst pain) | Perioperative/Periprocedural: 24 hours after surgery completed |
| Length of hospital stay | Length of hospital stay for the patient participants after surgery completed measured in minutes. Longer stay defined as greater number of minutes | Perioperative/Periprocedural |
| Complications | Presence of nausea or vomiting after surgery in patient participants. Yes responses indicate the presence of complications | Perioperative/Periprocedural |
| Hospital Readmission | Hospital readmission to patient participants within 30 days after surgery completed. Yes indicates a hospital readmission | Perioperative/Periprocedural |
| Use of non-medicine methods to relieve pain | Provided a checklist to patient participants of non-medicine choices such as cold pack, meditation, prayer, massage, distraction like watching television. A yes to any of these choices indicates use of non-medicine methods to relieve pain | Perioperative/Periprocedural |
| Overall Quality of Surgical Visual Field | Question to the surgeon with choices rating the overall surgical conditions throughout the procedure from extremely poor with a choice of 1 to optimal with a choice of 5. Higher scores indicate a better overall quality of surgical visual field | Perioperative/Periprocedural |