Preoperative Maximum Inspiratory Pressure and Outcomes After Interscalene Block in Obese Patients

NCT ID: NCT06549244

Last Updated: 2024-08-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2024-01-10

Brief Summary

The study aims to explore if Maximum Inspiratory Pressure can predict postoperative breathlessness in obese patients receiving interscalene blocks for shoulder surgery.

The main question is: does baseline Maximum Inspiratory Pressure have any association with postoperative breathlessness after interscalene blocks in class 2 or higher obese patients (BMI>35).

Preoperative and postoperative lung volumes, pressures, breathlessness score and respiratory outcomes will be measured on participants already receiving shoulder surgery with interscalene blocks.

Conditions

Dyspnea After Interscalene Nerve Block

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Block, Non-obese

Non-obese, Body Mass Index (BMI)\<30, receiving interscalene block and general anesthesia for shoulder surgery

Maximum Inspiratory Pressure monitoring

Intervention Type: DIAGNOSTIC_TEST

Lung volumes, pressures and breathlessness scores to be measured in pre and post operative phase of care on the same day

Block, Obese

Class 2 or higher Obese, BMI\>35, receiving interscalene block and general anesthesia for shoulder surgery

Maximum Inspiratory Pressure monitoring

Intervention Type: DIAGNOSTIC_TEST

Lung volumes, pressures and breathlessness scores to be measured in pre and post operative phase of care on the same day

Control

control group, included non-shoulder surgery patients receiving general anesthesia only

Maximum Inspiratory Pressure monitoring

Intervention Type: DIAGNOSTIC_TEST

Lung volumes, pressures and breathlessness scores to be measured in pre and post operative phase of care on the same day

Interventions

Maximum Inspiratory Pressure monitoring

Lung volumes, pressures and breathlessness scores to be measured in pre and post operative phase of care on the same day

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Spirometry measurements, Modified Borg breathlessness questionnaire

Eligibility Criteria

Inclusion Criteria

• Adults >18 years of age receiving shoulder surgery with preoperative interscalene block and general anesthesia;
• Speak English;

Group 3

· Adults >18 years of age receiving cystoscopy or lower extremity procedures receiving general endotracheal anesthesia

Exclusion Criteria

• Less than 18 years of age;
• currently pregnant;
• currently incarcerated;
• those with significant neuromuscular disease, tracheo-bronchial structural abnormalities, severe respiratory or severe cardiovascular comorbidity;
• those undergoing intra-abdominal or intrathoracic surgeries due to the potential to independently effect breathing

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Monika Nanda

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Locations

University of North Carolina

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

23-0924

Identifier Type: -

Identifier Source: org_study_id