Comparison of Sprotte and Quincke spinal needles on the frequency of spinal anesthesia failure in patients undergoing cesarean delivery

The aim of this study is the comparison of Sprotte and Quincke spinal needles on the frequency of spinal anesthesia failure in patients undergoing cesarean delivery.

Clinical trial with community-based and pragmatic control group, with parallel groups, double blind, randomized.

In this prospective and randomized study ,100 healthy pregnant women between ages of 18to40 and singleton pregnancy undergoing elective cesarean delivery receive spinal anesthesia using non-cutting Sprotte (study group; n=50) or cutting Quincke (control group; n=50) needles during 6 months in the Al-Zahra Hospital. The frequency of “overall“ and “partial” failure of spinal block and and post operated side effects related to spinal anesthesia are recorded. anesthesiologist is responsible for anesthesia management, patient monitoring, and preparation of study solutions.And the thesis student who is blinded to the study group is responsible for collecting information and data of patients.

Inclusion criteria : Candidate for elective cesarean delivery, Aged 18-40 years, ASA Class I&II, Term and singleton pregnancy, Exclusion criteria : Contraindication to spinal anesthesia, Allergy to local anesthetics, History of psychiatric disease, History of systemic diseases (cardiovascular, hepatic, pulmonary, ...), Spinal cord stenosis and lumbar discopathy,

Intervention group: The patients of study group (n=50) using of Sprotte spinal needle G25( manufacturer: B brown) undergoing spinal anesthesia and the patients of control group (n=50) using of Quincke spinal needle G25 ( manufacturer: B brown)undergoing spinal anesthesia.

Frequency of “overall“ and “partial” failure of spinal block and postoperative side effects related to spinal anesthesia.

Patients wishing to participate in the study who meet the inclusion criteria will be selected as convenient sampling and then randomly assigned to two control and intervention groups using Randlist software.

In present study, patients, investigator, care provider, outcome assessor and data analyzer are blinded to participants study groups. The study team includes an anesthesiologists, who is responsible for data collection and outcome assessing, who is not in charge of anesthesia management, thus is not aware of interventions and study group. In addition, all study groups and subsequent interventions will be introduced to the patients and it will been mentioned in the written consent that patients will be blinded to the study groups and interventions .Patients are allocated into study and control groups, according to a two blocked randomization list that is prepared using online software at a 1:1 ratio. The list is coded (A or B) that is preprinted in sealed-envelope packets. Except for one of anesthetists, all of researchers are blinded to the type of spinal needle for every patient during the study

A portion of the data that represents the final outcome

starting 6 months after publication

All Physicians and residents of the department of Anesthesia

There will be no specific limitations to the utilization of the data.

Dr .Simin Atashkhoei Al-Zahra Hospital South Artesh Street, Al-Zahra Hospital, Tabriz East Azarbaijan Islamic Republic of Iran Phone+98 41 1553 9161 Fax+98 41 1556 6449 siminatashkhoii@yahoo.com

Be approved by the Research Vice-President at first