Post-operative Outcomes in the Pyloromyotomy Procedure Under Spinal Anesthesia

Post-operative Outcomes in the Pyloromyotomy Procedure Under Spinal Anesthesia: A Retrospective Study in 100 Cases

Infantile hypertrophic pyloric stenosis (HPS) is one of the most common gastrointestinal medical emergencies.This retrospective study will review the files of all infants with HPS, who were treated by open pyloromyotomy under spinal anesthesia in the Bnai Zion Medical Center between the years 2006 to 2015.

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain
• Intervention / Treatment: Other: Spinal anesthesia

Detailed Description

Infantile hypertrophic pyloric stenosis (HPS) is one of the most common gastrointestinal medical emergencies that occur during the first 2 months of life.

Anesthetic induction and airway management of infants with HPS can be challenging because of the accumulation of significant volumes of gastric content, predisposing these patients to pulmonary aspiration during the induction of general anesthesia Despite the correction of systemic metabolic alkalosis, cerebrospinal fluid can remain alkalotic, and in this context hyperventilation and opioids may increase the risks of post-operative central apnea. All of the above anesthetics risks urged some anesthetists to alternatively use spinal anesthesia (SA) in infants undergoing pyloromyotomy.

This anesthetic technique proved to be both safe and efficient in infants undergoing pyloromyotomy, in addition to decreasing the mentioned risks associated with the other techniques.

This retrospective study will review the files of all infants with HPS, who were treated by open pyloromyotomy under SA in the Bnai Zion Medical Center between the years 2006 to 2015. It is designed to evaluate the postoperative full enteral feeding time, pain management and the incidence of post-operative apnea, the incidence of substantial vomiting episodes and other spinal anesthesia complications as secondary outcomes in infants undergoing pyloromyotomy under spinal anesthesia.

• Study Type: Observational
• Enrollment (Anticipated): 92

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All infants with Hypertrophic Pylorostenosis, who were treated by open pyloromyotomy under Spinal Anesthesia in the Bnai-Zion Medical Center between the years 2006 to 2015.

Description

Inclusion Criteria:

Infants with Hypertrophic Pylorostenosis, treated by open pyloromyotomy under Spinal Anesthesia

Exclusion Criteria:

Infants with Hypertrophic Pylorostenosis,treated by open pyloromyotomy under General Anesthesia

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Postoperative pain measure in numerical scale	till 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Vomiting measure in numbers	till 24 hours after surgery

Collaborators and Investigators

• Sponsor: Bnai Zion Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): February 1, 2017

Study Registration Dates

• First Submitted: August 18, 2016
• First Submitted That Met QC Criteria: August 24, 2016
• First Posted (Estimate): August 25, 2016

Study Record Updates

• Last Update Posted (Estimate): August 25, 2016
• Last Update Submitted That Met QC Criteria: August 24, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Pyloric stenosis spinal anesthesia postoperative pain
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: BnaiZionMC-16-LG-010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES