Comparison of Two Different Anesthesia Techniques in Outpatient Surgery

Study Overview
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Brief Summary
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Spinal anesthesia for anorectal surgery ( fistulotomy, fissure repair, pilonidal sinus excision,hemorrhoidectomy..) is a popular and widely used method characterized by rapid onset, delivery, easy mobilization and short hospital history. In order to minimize complications after spinal anesthesia, the use of lower-dose local anesthesia with the saddle block method has recently become widespread. Bupivacaine is often used for this method. Bupivacaine can be used hypobaric or hyperbaric in spinal anesthesia. Early mobilization and early discharge are important and necessary in an anorectal disease group that has such a high incidence and does not require rapid surgery and postoperative follow-up and hospitalization.Outpatient surgery is a very suitable surgical procedure for anorectal surgeries. In the light of all this information, the aim of this study is to evaluate and observe the hemodynamic data, bromage scores, mobilization and discharge of patients who underwent spinal anesthesia with two different techniques.

Detailed Description
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In this study, it is aimed to reduce long hospital stays and postoperative complications by comparing the postoperative mobilization, urination and discharge times of the patients after spinal anesthesia using 5mg hypobaric and 5 mg hyperbaric bupivacaine in patients who will undergo outpatient anorectal surgery. After the approval of the ethics committee in the operating room of the Ankara City Hospital, 68 patients who will undergo day surgery due to anorectal disease will be included in the study. This study was planned as observational. Both genders, American society of anesthesiology(ASA) score 1-2, 68 patients between the ages of 18-65 will be included in the study. The patients will be evaluated in 2 groups of 34 people. Patients with routine preoperative preparation, ECG, Spo2( oxygen saturation) and non-invasive blood pressure monitoring in the operating room and throughout the study will be included. Written informed consent will be obtained from patients. ECG, Spo2 and noninvasive blood pressure monitoring of the patients who are taken back to the hospitalization service for postoperative follow-up after the operation will continue. Patients will be followed up with: half-hourly intervals, first analgesic requirement, urination, mobilization times. If there are no complications, the patients will be discharged. The next day, patients will be called and questioned in terms of spinal anesthesia-related complications (headache, low back pain, urinary dysfunction…) and their anesthetic satisfaction will be noted. A total of minimum 68 (n1=34, n2=34) patients with effect size d=0.80, α=0.05 were found to be sufficient for 90% power in the sample size calculation. Parameters to look at: Operation time Intraoperative and postoperative vital monitoring need for sedation Time of sensory block to reach s4 dermatome The highest dermatome reached by sensory block Loss time of sensory block Modified bromage scale (5 minutes after spinal cord, end of operation, 1 postoperative 15 minutes, time to zero value) Time to first postoperative analgesic requirement Postoperative urination time Postoperative mobilization time Presence of complications related to spinal anesthesia patient satisfaction.

Official Title
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Comparison of Two Different Spinal Anesthesia Techniques in Outpatient Anorectal Surgery

Conditions
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Spinal Anesthesia Techniques

Intervention / Treatment
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* Procedure: use of different spinal anesthesia techniques


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both sexes undergoing anorectal surgery, 18-65 years old, ASA score 1-2 patients Exclusion Criteria: be under the age of 18 be over 65 ASA score of 3 and greater than 3 patients with fever those who are pregnant Patients with kidney failure Patients with hepatic insufficiency Patients with heart failure Patients with upper respiratory tract symptoms Patients with coagulation disorders Patients with infection in the lumbar region Patients with BMI <18 and BMI >40 Patients with uncontrolled hypertension, diabetes, pheochromocytoma and thyroid dysfunction Those who do not have the ability to read, write or understand the consent form Patients who do not want to sign the consent form Patients deemed unsuitable by the investigator

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: use of different spinal anesthesia techniques|Comparison of spinal anesthesia with 5 mg hypobaric bupivacaine and 5 mg hyperbaric bupivacaine in outpatients|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discharge Time | to determine the time at which patients are ready for discharge | 1 day after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Bromage Scale | to determine the amount of motor function | ıt is to be registered in 5th minutes after spinal anesthesia, end of the surgery, postop 15.minutes, postop 30.minutes, postop 45.minutes, postop 60.minutes and 1 day after surgery | 
| Time Of First Analgesic Need | to measure when the pain started | 1 day after surgery | 
| Urination Time | to determine the presence of urinary dysfunction | 1 day after surgery | 
| Mobilization Time | with a modified bromage scale of zero and able to walk unaided | 1 day after surgery | 
| Postoperative Complication | presence of headache, urinary dysfunction, postoperative nausea and vomiting | 1 day after surgery | 
| Blood Pressure | systolic, diastolic and mean arterial pressure,to determine the hemodynamic effects of spinal anesthesia | it is registered in entry, intraop 5.minutes,10.minutes,15.minutes, 20.minutes, 25.minutes, 30.minutes, 35.minutes, 40.minutes, 45.minutes, 50.minutes, 55.minutes,60. minutes ,postoperative 1st hour ,postoperative 2nd hour,postoperative 3rd hour | 
| Heart Rate | to determine the hemodynamic effects of spinal anesthesia | it is registered in entry, intraop 5.minutes,10.minutes,15.minutes, 20.minutes, 25.minutes, 30.minutes, 35.minutes, 40.minutes, 45.minutes, 50.minutes, 55.minutes,60. minutes ,postoperative 1st hour ,postoperative 2nd hour,postoperative 3rd hour | 
| Spo2 | to determine the hemodynamic effects of spinal anesthesia | it is registered in entry, intraop 5.minutes,10.minutes,15.minutes, 20.minutes, 25.minutes, 30.minutes, 35.minutes, 40.minutes, 45.minutes, 50.minutes, 55.minutes,60. minutes ,postoperative 1st hour ,postoperative 2nd hour,postoperative 3rd hour | 
| Number of Participants with Sedation Need | to determine whether sufficient sensory block has occurred | intraoperative, during surgery | 
| The Highest Dermatome Reached By The Sensory Block | to determine whether sufficient sensory block has occurred | intraoperative | 
| S4 Dermatome Sensory Blockage Time | to determine the time it takes for adequate sensory block to occur for surgery | preoperative, intraoperative | 
| Time to Disappearance of Sensory Block | to calculate the duration of the effect of spinal anesthesia | 1 day after surgery |