Post-operative Outcomes in the Pyloromyotomy Procedure Under Spinal Anesthesia

• Conditions: Postoperative Pain

• Registration Number: NCT02879292
• Lead Sponsor: Bnai Zion Medical Center

Brief Summary

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.

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 Timeline

• Status Verified: 2016-08
• Study First Submitted: 2016-08-18
• Study First Submitted QC: 2016-08-24
• Last Update Submitted: 2016-08-24
• Study First Posted: 2016-08-25
• Last Update Posted: 2016-08-25
• Study Start: 2016-12
• Primary Completion: 2016-12
• Study Completion: 2017-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 92

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative pain measure in numerical scale	till 24 hours after surgery

Secondary Outcome Measures

Name	Time	Method
Vomiting measure in numbers	till 24 hours after surgery