Quality of Recovery Under Low or Standard Pneumoperitoneum Pressure

NCT05040022 | Unknown Phase 4

• 1 other identifier: CAAE 49753621.1.0000.5373
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The use of low-pressure pneumoperitoneum seems to be able to reduce complications such as postoperative pain. However, the quality of evidence for most studies evaluating this relationship is considered low. The absence of concealment of pneumoperitoneum pressure and the lack of description of neuromuscular blockade characteristics are the main causes of bias. The purpose of this study will be to evaluate by means of a prospective, randomized and double-blinded trial, the quality of recovery (QoR-15) questionnaire of patients undergoing laparoscopic cholecystectomy under moderate neuromuscular blockade, using low pneumoperitoneum pressure or "standard" pressure. Eighty patients submitted to laparoscopic cholecystectomy and randomly distributed in two groups will be included: low pneumoperitoneum pressure (10 mmHg) or "standard" pressure (14 mmHg). The value of abdominal pressure will be kept hidden for all participants, except for the nurse responsible for the operating room. Moderate neuromuscular blockade will be maintained according to Train-of-four count (TOFc) = 3 for all cases.

Conditions

Quality of Recovery; Postoperative Pain; Postoperative Nausea and Vomiting; Neuromuscular Blockade

Outcome Measures

Primary Outcomes (1)

• Quality of recovery

  The quality of recovery will be assessed using the Qualtity of Recovery 15 questionnaire. Total scores range from 0 to 150. Higher scores mean a better outcome.

  From randomization up to 15 days

Secondary Outcomes (1)

• Postoperative pain

  From the PACU arriving up to 24 hours

Study Arms (2)

Group pneumoperitoneum pressure 10

ACTIVE COMPARATOR

Pneumoperitoneum pressure at 10 mmHg

Drug: Pneumoperitoneum pressure 10 mmHg

Group neumoperitoneum pressure 14

PLACEBO COMPARATOR

Pneumoperitoneum pressure at 10 mmHg

Drug: Pneumoperitoneum pressure 14 mmHg

Interventions

Pneumoperitoneum pressure 10 mmHg DRUG

The abdomen will be inflated with carbon dioxide to maintain the intra-abdominal pressure at 10 mmHg (group 10)

Group pneumoperitoneum pressure 10

Pneumoperitoneum pressure 14 mmHg DRUG

The abdomen will be inflated with carbon dioxide to maintain the intra-abdominal pressure at 14 mmHg (group 14).

Group neumoperitoneum pressure 14

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physical status I and II according to the American Society of Anesthesiologists (ASA)
• Undergoing elective laparoscopic cholecystectomy

You may not qualify if:

• refuse to participate
• Present inability to communicate due to altered level of consciousness or due to the presence of neurological or psychiatric illness
• Present contraindication to the use of any of the drugs employed in the study
• Present history of alcohol or drug addiction
• Body mass index (BMI) ≥ 35
• Presence of chronic pain or use of opioids.

Sponsors & Collaborators

• Pontificia Universidade Catolica de Sao Paulo: lead

Study Sites (1)

Eduardo T Moro

Araçoiaba da Serra, São Paulo, 18190-000, Brazil

Location

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting

Study Officials

• Eduardo Moro

  Faculdade de Ciências Médicas e da Saúde PUCSP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eduardo Moro

CONTACT

15997728015; edumoro85@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients will be randomized according to the sequence of random numbers generated by a computer using a specific program (www.random.org). For each patient, an opaque envelope containing the group to which the patient will be allocated will be prepared, sealed, and numbered sequentially.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Prospective, randomized and double-blinded

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: September 10, 2021
• Study Start: October 1, 2021
• Primary Completion: January 5, 2022
• Study Completion: January 15, 2022
• Last Updated: September 20, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: When summary data are published
• Access Criteria: The access will be related to the journal (open access or not)

Locations

BR (1)