Factors Associated With Failed Spinal Anesthesia for Cesarean Delivery

NCT04685980 | Completed DMC

• 2 other identifiers: 290/2563 (EC1)445/2020
• Study Type: observational
• Target: 440
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to reveal the factor associated with failed spinal anaesthesia in cesarean delivery. We conduct the retrospective case-control study to elucidate the involving factors.

Conditions

Anesthesia; Adverse Effect; Cesarean Section Complications

Keywords

Spinal anaesthesia; cesarean section

Outcome Measures

Primary Outcomes (4)

• Age

  Factors involving failed spinal anaesthesia for cesarean delivery: patient age

  At starting operation

• Body mass index

  Factors involving failed spinal anaesthesia for cesarean delivery: patient body mass index (BMI) : weight and height will be combined to report BMI in kg/m\^2

  At starting operation

• Anaesthesiologist performing spinal anaesthesia

  Factors involving failed spinal anaesthesia for cesarean delivery: Anaesthesiologist performing spinal anaesthesia (resident or consultant)

  At starting anaesthesia

• Time starting of operation

  Factors involving failed spinal anaesthesia for cesarean delivery: at which time cesarean delivery starting to performed eg. in office hour or out of office hour

  At starting operation

Secondary Outcomes (1)

• Incidence of failed spinal anaesthesia for cesarean delivery

  At starting operation

Study Arms (2)

Failed spinal anaesthesia group

Failed spinal anaesthesia: failure of anaesthetic level of blockade both sensory and motor blockage, and consequently receive general anaesthesia

Procedure: spinal anaesthesia with local anaesthetic and intrathecal morphine

Control Group

Patient receiving spinal anaesthesia and successfully finish the cesarean section

Procedure: spinal anaesthesia with local anaesthetic and intrathecal morphine

Interventions

spinal anaesthesia with local anaesthetic and intrathecal morphine PROCEDURE

Patients undergoing cesarean delivery and received spinal anaesthesia with local anaesthetic and intrathecal morphine

Control Group; Failed spinal anaesthesia group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women who gestational age \> 24 weeks and patient age more than or equal to 18 years, undergoing cesarean delivery and received spinal anaesthesia.

You may qualify if:

• Age \>,= 18 years
• Undergoing cesarean delivery
• Failed spinal anaesthesia and received general anaesthesia with endotracheal tube

You may not qualify if:

• Gestational age \< 24 weeks
• Received combined spinal-epidural anaesthesia
• Received peripheral nerve blockade

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Anesthesiology department, Siriraj hospital, Mahidol University

Bangkok, 10700, Thailand

Location

Related Publications (1)

• Punchuklang W, Nivatpumin P, Jintadawong T. Total failure of spinal anesthesia for cesarean delivery, associated factors, and outcomes: A retrospective case-control study. Medicine (Baltimore). 2022 Jul 8;101(27):e29813. doi: 10.1097/MD.0000000000029813.

  PMID: 35801788 RESULT

MeSH Terms

Interventions

Anesthesia, Spinal; Anesthesia, Local

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Patchareya Nivatpumin, M.D.

  Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, THAILAND

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 28, 2020
• Study Start: December 25, 2020
• Primary Completion: February 15, 2021
• Study Completion: August 31, 2021
• Last Updated: April 11, 2023

Record last verified: 2023-04

Locations

TH (1)