NCT04398810

Postoperative Pain Results According to Pressure to Form Pneumoperitoneum

A Comparison of Postoperative Pain Results According to Pressure to Form Pneumoperitoneum During Robot-assisted Single-port Cholecystectomy; a Randomized Controlled Trial.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Seoul St. Mary's Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study showed the difference in postoperative pain between the groups that performed surgery with the low-pressure pneumoperitoneum and the group that performed surgery in the standard-pressure pneumoperitoneum when robotic single-hole cholecystectomy was performed. The primary purpose of the study was to compare the differences in the visual analog scale (VAS) between the two groups and to demonstrate the effectiveness of pain relief after surgery. Secondly, the effect of the low-pressure pneumoperitoneum on the patient's postoperative recovery and outcome was compared with the control group by comparing the length of stay, operation time, and postoperative complications.

Detailed description

Laparoscopic cholecystectomy was the most common treatment method for gallbladder-related diseases, and robotic cholecystectomy was also currently being performed. Many patients complained pain around the wound, shoulder and back after surgery. Several methods had been attempted to reduce postoperative pain, previous studies showed that oral medications such as NSAIDS, administration of local anesthetics in wounds and abdominal cavity, low-pressure penumoperitoneum, humidification of intraperitoneal washing fluid, And active residual gas suction in the abdominal cavity had been found to relieve postoperative pain. Robotic cholecystectomy, similar to laparoscopic cholecystectomy, also formed pneumoperitoneum to secure the surgical space during operation. Based on the results published in various studies, it had known that the most effective method of pain relief for laparoscopic pain was to create low-pressure pneumoperitoneum. In this study, investigators attempted to prove the effectiveness of low pressure pneumoperioneum through a prospective randomized controlled trial between the experimental group with the low-pressure pneumoperitoneum and the control group with the standard-pressure pneumoperitoneum during robotic single-hole cholecystectomy.

Conditions

• Cholecystitis
• Postoperative Pain

Interventions

Type	Name	Description
PROCEDURE	robotic single port cholecystectomy	1. Local anesthetic administration during wound incision In the experimental group and the control group, a local anesthetic was administered to the wound surface when a glove port was installed on the navel at the start of surgery. (bupivacaine 0.5% 14ml subcutaneous injection) 2. Residual gas aspiration 3. Pulmonary recruitment maneuver In both the experimental group and the control group, before the operation was completed and the wound was closed, the patient was taken to the Trenedelenburg position, and then the pressure of 60 cm H2o in the abdomen was applied, and manual inflation was performed twice, 5 seconds at a time, and pulmonary recruitment was performed. 4. Warming of the washing solution in the abdominal cavity

Timeline

• Start date: 2020-06-02
• Primary completion: 2020-12-30
• Completion: 2021-12-30
• First posted: 2020-05-21
• Last updated: 2020-05-21

Locations

1 site across 1 country: South Korea