An interventional study of Pneumoperitoneum pressure = 15mmHg and Pneumoperitoneum pressure = 12mm Hg in Hysterectomy and Pneumoperitoneum, sponsored by University of Arizona. Completed at 1 site in United States. Open to female participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-07.
Sponsored by University of Arizona · Not applicable, Interventional, and Other
With the limited evidence that lower pneumoperitoneum pressures improve postoperative pain in laparoscopic or robotic hysterectomy for benign indications, we would like to determine if we can both further validate this idea but also show that it has minimal effect on physician satisfaction performing the surgery.
Minimally invasive hysterectomy, including conventional laparoscopic and robotic-assisted hysterectomy, is a commonly performed gynecologic surgery that universally results in postoperative pain for patients. Opioid medications are helpful to control postoperative pain and are routinely given to women who undergo minimally invasive hysterectomy. However, opioid abuse is on the rise in the United States, and there is increased awareness of misuse leading to abuse, overdose, and chronic opioid use. In addition to narcotic usage, postoperative pain also has negative effects on patient satisfaction and length of stay in the post-anesthesia care unit (PACU) leading to potential hospital admission. There is existing evidence that reducing the pressure used to create the pneumoperitoneum during laparoscopic surgery may affect pain scores that patients endorse in the PACU. Due to improved postoperative pain, patients may have decreased opioid use in the PACU and at home, shorter hospital stay, and improved overall patient satisfaction. If lower pneumoperitoneum pressures during laparoscopic surgery can be shown to reduce postoperative pain, then the ultimate question becomes whether there is ability to adapt this practice of using lower pressures to maintain pneumoperitoneum. It is unclear whether physician satisfaction will be affected.
There are several publications investigating the effect of lower pneumoperitoneum pressures on postoperative pain. A systematic review in 2016 included 238 patients (three RCTs), showed pneumoperitoneum pressures of 8mmHg had a statistically significant although minimal decrease in postoperative pain compared to 12mmHg, although lower pressures were associated with worse visualization. The authors concluded that the systematic review was inconclusive and further studies were necessary. A randomized pilot study with 60 patients comparing low pressure (7mmHg) using the AirSeal System versus standard insufflation (15mmHg), showed lower postoperative shoulder pain in the group with lower pressure using the AirSeal system. Two abstracts in the Journal of Minimally Invasive Gynecology present retrospective studies showing decreased postoperative pain with lower pneumoperitoneum pressure. The first abstract is from 2015, included a sample size of 170 patients who underwent benign robotic gynecologic surgery, 85 patients in each arm (12mmHg and 15mmHg). They showed no difference in median recovery time in the PACU and significantly lower median first pain score (5 vs 6, p=.04). The second abstract is from 2018 and included a sample size of 598 patients who underwent benign robotic gynecologic surgery, 99 patients in 15mmHg arm, 100 patients in 12mmHg arm, 99 patients in 10mmHg arm, and 300 patients in 8mmHg arm. They showed lower initial pain scores with each degree of lower pressure (5.9 vs 5.4 vs 4.4 vs 3.8, p=\<.0001) and shorter hospital stays with lower pressures. They showed no difference in operative times or blood loss in the four arms. Similar studies have been done with cholecystectomy patients that have shown improved postoperative shoulder pain with lower pneumoperitoneum pressures. There is also an ongoing clinical trial that is still recruiting patients that is studying this similar comparison using 9mmHg vs 15mmHg with and without the AirSeal system.
However, the literature summarized here has never included blinding the intervention of lower pneumoperitoneum pressure to the surgeon to determine awareness of pressure and its effect on visualization and physician satisfaction.
149 studies on the registry are indexed under Pneumoperitoneum; 29 are open to participants now.
This study's enrollment of 40 is below the median of 79 across 96 interventional studies indexed under Pneumoperitoneum.
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Exclusion Criteria:
1. Pneumoperitoneum will be set at 15mmHg
Other: Pneumoperitoneum pressure = 15mmHg
2.Pneumoperitoneum will be set at 12mmHg
Other: Pneumoperitoneum pressure = 12mm Hg
3. Pneumoperitoneum will be set at 10mmHg
Other: Pneumoperitoneum pressure = 10mmHg
Randomized pneumoperitoneum 1
Randomized pneumoperitoneum 2
Randomized pneumoperitoneum 3
Physician Satisfaction Part 1
Physician satisfaction questionnaire completed immediately postoperative, 3 questions in length and measured with VAS score (0-5)
Time frame: From completion of surgery to one hour postoperative
Physician Satisfaction Part 2
Included in the physician satisfaction questionnaire is presumed pneumoperitoneum pressure, measured as 10mmHg, 12mmHg, or 15mmHg (circle one - 10mmHg, 12mmHg, 15mmHg)
Time frame: From completion of surgery to one hour postoperative
Physician Satisfaction Part 3
Included in the physician satisfaction questionnaire are two yes/no questions on effect of pneumoperitoneum on visualization and operative time (circle one - yes, no)
Time frame: From completion of surgery to one hour postoperative
Postoperative Pain
Self reported pain intensity in PACU (VAS 0-10) first reported and maximum pain score, pain score at 6 hours postoperative, and pain score at 24 hours postoperative
Time frame: From completion of surgery to 24 hours postoperative
Postoperative Shoulder Pain
Self reported shoulder pain intensity (VAS 0-10) at 6 hours postoperative and pain score at 24 hours postoperative
Time frame: From completion of surgery to 24 hours postoperative
Narcotic usage
Morphine equivalent units in PACU and at 24 hours postoperative
Time frame: From completion of surgery to 24 hours postoperative
Length of hospital stay
Time in minutes of length of stay in hospital
Time frame: From completion of surgery to hospital discharge time up to 7 days
Patient Satisfaction
Patient satisfaction questionnaire completed 24 hours postoperative over the phone, 2 questions in length, VAS score (0-5) on satisfaction with overall postoperative pain and shoulder postoperative pain
Time frame: From completion of surgery to 24 hours postoperative
Intraoperative Respiratory Parameters: Peak inspiratory pressure
Peak inspiratory pressure
Time frame: From start of surgery to end of surgery
Intraoperative Respiratory Parameters: Tidal volume
Tidal volume
Time frame: From start of surgery to end of surgery
Intraoperative Respiratory Parameters: End tidal CO2
End tidal CO2
Time frame: From start of surgery to end of surgery
Plan to share: Yes — De-identifed individual participant data for all primary and secondary outcomes measures will be made available.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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