Postoperative Pain Results According to Pressure to Form Pneumoperitoneum

NCT ID: NCT04398810

Last Updated: 2020-05-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-02
• Study Completion Date: 2021-12-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

the low-pressure pneumoperitoneum during surgery

A. Inclusion criteria Patients who underwent elective gallbladder surgery

• Cholelithiasis
• Chronic cholecystitis
• Gallbladder polyps
• Gallbladder adenoma
• Porcelain gallbladder

The experimental group controls the CO2 flow that is injected into the abdominal cavity during surgery and maintains the pressure in the abdominal cavity at a low level of 5 mmHg to perform the surgery.

Group Type: EXPERIMENTAL

robotic single port cholecystectomy

Intervention Type: PROCEDURE

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

the standard-pressure pneumoperitoneum during surgery

A. Inclusion criteria Patients who underwent elective gallbladder surgery

• Cholelithiasis
• Chronic cholecystitis
• Gallbladder polyps
• Gallbladder adenoma
• Porcelain gallbladder

In the case of the control group, surgery is performed while maintaining the pressure in the abdominal cavity at 12 mmHg as generally performed during surgery.

Group Type: EXPERIMENTAL

robotic single port cholecystectomy

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

Patients who underwent elective gallbladder surgery

• Cholelithiasis
• Chronic cholecystitis
• Gallbladder polyps
• Gallbladder adenoma
• Porcelain gallbladder

Exclusion Criteria

1. Acute cholecystitis patient group

• Necrotic gallbladder
• Collapsed gallbladder
• Gallbladder pustosis
• Gallbladder emphysema
• Hemorrhagic gallbladder
• Perforated gallbladder

2. cholecystitis with a gallbladder thickness of 4 mm or more on CT or ultrasound

3. cholecystitis with adhesions to surrounding organs due to inflammation of the gallbladder

4. Patient group performing surgery concurrently due to other organ diseases

5. Immunosuppressive patient group

• Transplant patient group: Liver transplant patient group (PSLT), Kidney transplant patient group (PSKT)
• AIDS patients group

6. Patient group with history of open abdominal surgery

7. Transplant group during open surgery

8. Patients under 19 years of age.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul St. Mary's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Taeho Hong

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Won jong Kim, MD

Role: STUDY_DIRECTOR

The Catholic University of Korea

Locations

Department of HBP Surgery, Seoul St. Mary's hospital

Seoul, Seocho-gu, Banopo-dong, South Korea

Countries

South Korea

Central Contacts

Tae ho Hong, MD. PhD

Role: CONTACT

gshth@catholic.ac.kr

+82-10-5206-5266

Sung eun Park, MD

Role: CONTACT

carin337@naver.com

+82-10-5775-9351

Facility Contacts

Taeho Hong, MD, PhD

Role: primary

gshth@catholic.ac.kr

+82-2-2258-6108

Other Identifiers

Seoul-09

Identifier Type: -

Identifier Source: org_study_id