Short Title: Standard vs. Lower Pressure Pneumoperitoneum

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06338865
Study type	Interventional
Source	Cedars-Sinai Medical Center
Contact	Rebecca Schneyer, MD
Phone	914-391-2604
Email	rebecca.schneyer@cshs.org
Status	Recruiting
Phase	N/A
Start date	May 3, 2024
Completion date	April 2027

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01114971` - Labetalol and Esmolol: Vital Signs and Post Operative Pain Management	Phase 4
Completed	`NCT05624346` - The Effect of Respiratory Exercise After Laparoscopic Surgery	N/A
Not yet recruiting	`NCT04999696` - Minimally Invasive Therapy Versus Open Radical Hysterectomy for Management of Early Stage Cervical Cancer	N/A
Completed	`NCT01084200` - Comparison of Sevoflurane, Propofol, and Sevoflurane Plus Propofol for Maintenance of Anaesthesia	Phase 4
Not yet recruiting	`NCT00731107` - XCEL Bladeless Trocar Versus Veress Needle: A Randomised Controlled Trial Comparing These Two Entry Techniques in Gynaecological Laparoscopic Surgery.	N/A
Not yet recruiting	`NCT06050161` - Evaluating Artisential Laparoscopic Instruments in Gynecologic Surgery	N/A
Recruiting	`NCT05005117` - Laparoscopic Approach for Emergency Colon Resection	N/A
Recruiting	`NCT05436899` - A Pilot Study on Training Simulator Efficacy	N/A
Recruiting	`NCT05542823` - Effect of Cuff Pressure of Endotracheal Tube on POST
Terminated	`NCT03684304` - The Effect of Abdominal Binder Use on Postoperative Pain and Mobility in Patients Undergoing Pelvic Surgery	N/A
Completed	`NCT04146090` - Low-pressure vs Standard-pressure in Laparoscopic Cholecystectomy	N/A
Terminated	`NCT01436032` - Efficacy, Safety and Tolerability Study of N1539 in Subjects After Abdominal Laparoscopic Surgery	Phase 3
Active, not recruiting	`NCT05109130` - Change of Circulating Tumor Cells During Laparoscopic or Transanal Endoscopic Surgery for Rectal Cancer.
Completed	`NCT04642118` - Low-pressure Pulmonary Recruitment Maneuver to Decrease Post-laparoscopic Shoulder Pain in Gynecologic Surgery	N/A
Recruiting	`NCT06150079` - Individualized PEEP Titration on Postoperative Pulmonary Complications	N/A
Completed	`NCT05121454` - Validation of Serenno CUO and IAP Measuring Device
Not yet recruiting	`NCT05092425` - Analysis of Risk Factors for Children With Heterochronous Indirect Hernia
Recruiting	`NCT03318185` - Gasless Single-port Laparoscopic-assisted Radical Resection for Rectal Carcinoma	N/A
Completed	`NCT03506555` - Laparoscopic Access in General Surgery: the Closed (Veress Needle) Technique Versus the Open (Hasson) Technique	N/A
Not yet recruiting	`NCT02769325` - Atropine in Laparoscopic Gynaecological Surgery	Phase 4