Gynecologic Surgical Procedures
Conditions
Keywords
pain, abdominal pressure
Brief summary
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: * Undergo their regular scheduled gynecologic laparoscopic surgery * Complete pain measures one hour, 3 hours, and 24 hours after surgery
Detailed description
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.
Interventions
PROCEDUREabdominal pressure
type of intra-abdominal pressure of either standard or low pressure
Sponsors
Nassau University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Undergoing benign gynecologic laparoscopic surgery with eligible procedures, including the following. * Salpingectomy * Cystectomy * Oophorectomy * Myomectomy * Hysterectomy. * Only those who speak English or Spanish will be recruited, as our validated questionnaires are only available in those languages.
Exclusion criteria
* Participants with the following diseases will be excluded due to their diseases having pain that may strongly interfere with their perception of pain in the area of surgery. * Arthritis * Gout * Metastatic cancer * Pelvic floor disease * Headache disorders * Herpes zoster or shingles * Frozen shoulder * Complex regional pain syndrome (CRPS) * Slipped disc * Sickle cell disease * Sciatica * Trigeminal neuralgia * Fibromyalgia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PAIN OUT questionnaire | Perioperative/Periprocedural: Three hours after surgery completed | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PAIN OUT questionnaire | Perioperative/Periprocedural: 24 hours after surgery completed | 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. |
| Numerical rating scale for pain location in the abdomen | Perioperative/Periprocedural: One hour after surgery | One item to patient participants to rate the abdominal pain from 0 (no pain) to 10 (worst pain) |
| Numerical rating scale for pain location in the shoulder | Perioperative/Periprocedural: One hour after surgery | One item to patient participants to rate the shoulder pain from 0 (no pain) to 10 (worst pain) |
| Visual analog scale for pain location in the abdomen | Perioperative/Periprocedural: Three hours after surgery completed | One item to patient participants to rate the abdominal pain from 0 (no pain) to 10 (worst pain) |
| Length of hospital stay | Perioperative/Periprocedural | Length of hospital stay for the patient participants after surgery completed measured in minutes. Longer stay defined as greater number of minutes |
| Complications | Perioperative/Periprocedural | Presence of nausea or vomiting after surgery in patient participants. Yes responses indicate the presence of complications |
| Hospital Readmission | Perioperative/Periprocedural | Hospital readmission to patient participants within 30 days after surgery completed. Yes indicates a hospital readmission |
| Use of non-medicine methods to relieve pain | Perioperative/Periprocedural | 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 |
| Overall Quality of Surgical Visual Field | Perioperative/Periprocedural | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPetr Itzhak, DO
Nassau University Medical Center
Outcome results
None listed