Respiratory Rate After Cesarean Delivery

NCT04250233 | Completed

• 1 other identifier: TASMC-2020-CFW-608-19-CTIL
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The study proposal summarizes aspects related to respiratory rate in women who undergo spinal anesthesia for cesarean delivery who receive or do not receive neuraxial opioids

Conditions

Cesarean Delivery; Neuraxial Opioids

Outcome Measures

Primary Outcomes (1)

• Respiratory rate ≤8

  Our primary study aim is to report the number of women with RR≤8 at any time point after the cesarean delivery using the continuous respiratory monitoring device.

  up to 24 hours

Secondary Outcomes (11)

• respiratory rate per min

  up to 24 hours

• oxygen saturation

  up to 24 hours

• heart rate

  up to 24 hours

• apnea

  up to 24 hours

• side effects

  up to 24 hours

Study Arms (2)

Standard neuraxial opioids

Standard neuraxial anesthesia for cesarean delivery (heavy bupivacaine 10 mg; fentanyl 10-25 mic; and low dose intrathecal morphine

Device: Respiratory Monitor

Non standard neuraxial opioids

Non standard low-dose morphine group (with heavy bupivacaine 10 mg; fentanyl 10-25 mic) Women are offered - if they prefer not to receive low dose morphine, the option of either ultra-low dose morphine or no morphine - instead they can receive postoperative bilateral quadratus lumborum block (QLB), TAP or erector spinus block.

Device: Respiratory Monitor

Interventions

Respiratory Monitor DEVICE

All women receive a respiratory rate monitor after cesarean delivery. We anticipate that at least 30 women will receive standard dose neuraxial block, and aim to have a cohort of 20-30 women who receive non-standard dose (Group 20 in order to compare respiratory rates.

Non standard neuraxial opioids; Standard neuraxial opioids

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: female pregnant
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women undergoing elective cesarean delivery under spinal anesthesia

You may qualify if:

• American Society of Anesthesiologists physical status class II or III
• age between 18 and 50
• gestational age greater than 37 completed weeks
• singleton pregnancy. In contrast to previous studies
• we do not plan to exclude obese women and those with suspected sleep apnea.

You may not qualify if:

• Contraindication for epidural analgesia (bleeding diathesis, neuropathy, severe scoliosis, previous spine surgery, local anesthetic allergy)
• narcotic administration in the previous 2 hours
• inability to adequately understand the consent form
• moderate-severe asthma, inability to receive morphine
• sensitivity to sticker
• skin conditions.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead
• Stanford University: collaborator

Study Sites (1)

Tel AViv Sourasky Medical Center

Tel Aviv, Israel

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: January 31, 2020
• Study Start: August 11, 2021
• Primary Completion: March 26, 2023
• Study Completion: March 26, 2023
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)