Clinical trial NCT02879292: Post-operative Outcomes in the Pyloromyotomy Procedure Under Spinal Anesthesia
Official title: Post-operative Outcomes in the Pyloromyotomy Procedure Under Spinal Anesthesia: A Retrospective Study in 100 Cases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Pain
Keywords: Pyloric stenosis spinal anesthesia postoperative pain
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-08-25
Enrollment: 92
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative pain measure in numerical scale
timeFrame: till 24 hours after surgery
Secondary outcomes:
measure: Vomiting measure in numbers
timeFrame: till 24 hours after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Bnai Zion Medical Center
name: mira koch, M.A.
role: STUDY_CHAIR
References: