Factors Associated With Failed Spinal Anesthesia for Cesarean Delivery

• Sponsor: Mahidol University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04685980
• Collaborator: (none)
• Enrollment: 440
• Location: 1
• Actual Duration (Months): 8.2
• Patients Per Site Per Month: 53.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia; Adverse Effect; Cesarean Section Complications	Procedure: spinal anaesthesia with local anaesthetic and intrathecal morphine

Detailed Description

Spinal anaesthesia is the anaesthetic technique of choice of patients undergoing cesarean delivery due to its rapid onset, good reliability and good efficacy. However, the inadequate or failed spinal anaesthesia can occur. The previous literatures revealed incidence of failed spinal anaesthesia was as high as 0.5-6%. Failure of spinal anaesthesia leads to numerous maternal and neonatal consequences. Those failed spinal anaesthesia patients required general anaesthesia with endotracheal tube which may cause several complications such as hypoxia, difficult intubation, failed intubation and pulmonary aspiration. Also, a recent network meta-analysis showed general anaesthesia decreasing neonatal Apgar score.

The factors that associated with failed spinal anaesthesia in cesarean delivery has been studied. The amount of local anaesthetic, needle type, patients' body mass index (obesity), and experiences of the anaesthetist performing spinal block influenced the failure of spinal anaesthesia. The details and factors of failed spinal anaesthesia in our hospital was scarce. It has not yet been published in the literature.

Therefore, 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 440 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Factors Associated With Failed Spinal Anesthesia for Cesarean Delivery, a Retrospective Case-control Study
• Actual Study Start Date: Dec 25, 2020
• Actual Primary Completion Date: Feb 15, 2021
• Actual Study Completion Date: Aug 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
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; Patients undergoing cesarean delivery and received 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; Patients undergoing cesarean delivery and received spinal anaesthesia with local anaesthetic and intrathecal morphine

Outcome Measures

Primary Outcome Measures

1. Age [At starting operation]

   Factors involving failed spinal anaesthesia for cesarean delivery: patient age

2. Body mass index [At starting operation]

   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

3. Anaesthesiologist performing spinal anaesthesia [At starting anaesthesia]

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

4. Time starting of operation [At starting 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

Secondary Outcome Measures

1. Incidence of failed spinal anaesthesia for cesarean delivery [At starting operation]

   Incidence of failed spinal anaesthesia for cesarean delivery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age >,= 18 years

• Undergoing cesarean delivery

• Failed spinal anaesthesia and received general anaesthesia with endotracheal tube

Exclusion Criteria:

• Gestational age < 24 weeks

• Received combined spinal-epidural anaesthesia

• Received peripheral nerve blockade

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anesthesiology department, Siriraj hospital, Mahidol University	Bangkok		Thailand	10700

Sponsors and Collaborators

• Mahidol University

Investigators

• Principal Investigator: Patchareya Nivatpumin, M.D., Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, THAILAND

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mahidol University
• ClinicalTrials.gov Identifier: NCT04685980
• Other Study ID Numbers: 290/2563 (EC1); 445/2020
• First Posted: Dec 28, 2020
• Last Update Posted: Sep 8, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mahidol University: Spinal anaesthesia; cesarean section
• Additional relevant MeSH terms: Morphine; Anesthetics; Anesthetics, Local

Study Results

No Results Posted as of Sep 8, 2021