Effect of Lower Pneumoperitoneum Pressure During Laparoscopic and Robotic Hysterectomy

The Effect of Lower Pneumoperitoneum Pressure During Laparoscopic and Robotic Hysterectomy: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Pneumoperitoneum; Hysterectomy
• Intervention / Treatment: Other: Pneumoperitoneum pressure = 15mmHg; Other: Pneumoperitoneum pressure = 12mm Hg; Other: Pneumoperitoneum pressure = 10mmHg

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Banner University Medical Center Phoenix

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• female patients
• greater than or equal to 18 years old
• English-speaking
• undergoing laparoscopic or robotic total hysterectomy for benign indications by one of the two minimally invasive gynecologic surgeons at Banner University Medical Center - Phoenix

Exclusion Criteria:

• patients with body max index >35
• American Society of Anesthesiologists (ASA) score III or IV
• preoperative uterine weight estimated to be greater than 500gm (measured by sonography and using the following formula: length x width x anteroposterior diameter x 0.52)
• patients on chronic opioids for chronic pain (defined as > 3 months regular opioid use)
• patients who refuse participation in the study
• patients who do not provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1. Pneumoperitoneum pressure = 15mmHg; 1. Pneumoperitoneum will be set at 15mmHg	Other: Pneumoperitoneum pressure = 15mmHg; Randomized pneumoperitoneum 1
Active Comparator: 2. Pneumoperitoneum pressure = 12mmHg; 2.Pneumoperitoneum will be set at 12mmHg	Other: Pneumoperitoneum pressure = 12mm Hg; Randomized pneumoperitoneum 2
Active Comparator: 3. Pneumoperitoneum set at 10mmHg; 3. Pneumoperitoneum will be set at 10mmHg	Other: Pneumoperitoneum pressure = 10mmHg; Randomized pneumoperitoneum 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician Satisfaction Part 1	Physician satisfaction questionnaire completed immediately postoperative, 3 questions in length and measured with VAS score (0-5)	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)	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)	From completion of surgery to one hour postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	From completion of surgery to 24 hours postoperative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Narcotic usage	Morphine equivalent units in PACU and at 24 hours postoperative	From completion of surgery to 24 hours postoperative
Length of hospital stay	Time in minutes of length of stay in hospital	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	From completion of surgery to 24 hours postoperative
Intraoperative Respiratory Parameters: Peak inspiratory pressure	Peak inspiratory pressure	From start of surgery to end of surgery
Intraoperative Respiratory Parameters: Tidal volume	Tidal volume	From start of surgery to end of surgery
Intraoperative Respiratory Parameters: End tidal CO2	End tidal CO2	From start of surgery to end of surgery

Collaborators and Investigators

• Sponsor: University of Arizona
• Investigators: Study Chair: Michael Foley, MD, Banner University Medical Center

Publications and helpful links

General Publications

• Bogani G, Uccella S, Cromi A, Serati M, Casarin J, Pinelli C, Ghezzi F. Low vs standard pneumoperitoneum pressure during laparoscopic hysterectomy: prospective randomized trial. J Minim Invasive Gynecol. 2014 May-Jun;21(3):466-71. doi: 10.1016/j.jmig.2013.12.091. Epub 2013 Dec 25.
• Kyle EB, Maheux-Lacroix S, Boutin A, Laberge PY, Lemyre M. Low vs Standard Pressures in Gynecologic Laparoscopy: a Systematic Review. JSLS. 2016 Jan-Mar;20(1):e2015.00113. doi: 10.4293/JSLS.2015.00113.
• Nasajiyan N, Javaherfourosh F, Ghomeishi A, Akhondzadeh R, Pazyar F, Hamoonpou N. Comparison of low and standard pressure gas injection at abdominal cavity on postoperative nausea and vomiting in laparoscopic cholecystectomy. Pak J Med Sci. 2014 Sep;30(5):1083-7. doi: 10.12669/pjms.305.5010.
• Sroussi J, Elies A, Rigouzzo A, Louvet N, Mezzadri M, Fazel A, Benifla JL. Low pressure gynecological laparoscopy (7mmHg) with AirSeal(R) System versus a standard insufflation (15mmHg): A pilot study in 60 patients. J Gynecol Obstet Hum Reprod. 2017 Feb;46(2):155-158. doi: 10.1016/j.jogoh.2016.09.003. Epub 2017 Jan 30.
• 3. Kim DK, Cheong ILY, Lee GY, Cho JH. Low pressure (8 mm Hg) pneumoperitoneum does not reduce the incidence and severity of postoperative nausea and vomiting (PONV) following gynecologic laparoscopy. Korean J Anesthesiol. 2006.
• Topcu HO, Cavkaytar S, Kokanali K, Guzel AI, Islimye M, Doganay M. A prospective randomized trial of postoperative pain following different insufflation pressures during gynecologic laparoscopy. Eur J Obstet Gynecol Reprod Biol. 2014 Nov;182:81-5. doi: 10.1016/j.ejogrb.2014.09.003. Epub 2014 Sep 16.

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2020
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): November 30, 2021

Study Registration Dates

• First Submitted: July 29, 2019
• First Submitted That Met QC Criteria: October 11, 2019
• First Posted (Actual): October 14, 2019

Study Record Updates

• Last Update Posted (Actual): December 7, 2021
• Last Update Submitted That Met QC Criteria: December 4, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Peritoneal Diseases; Pneumoperitoneum
• Other Study ID Numbers: 1909975965

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identifed individual participant data for all primary and secondary outcomes measures will be made available.
• IPD Sharing Time Frame: Data will be available within 6 months of study completion
• IPD Sharing Access Criteria: Data access requests will be reviewed by an external independent review panel. Requesters will be required to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No