Comparative Analysis of Hypobaric Versus Hyperbaric Bupivacaine for Spinal Anesthesia in Day-Case Anorectal Surgery: Efficacy, Safety, and Discharge Times
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ankara City Hospital Bilkent
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Discharge Time
Study Overview
Brief Summary
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
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:
Study Design
- Study Type
- Observational
- Observational Model
- Case Crossover
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Discharge Time
Time Frame: 1 day after surgery
to determine the time at which patients are ready for discharge
Secondary Outcomes
- Mobilization Time(1 day after surgery)
- Postoperative Complication(1 day after surgery)
- Number of Participants with Sedation Need(intraoperative, during surgery)
- Time to Disappearance of Sensory Block(1 day after surgery)
- Heart Rate(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)
- Modified Bromage Scale(5 minutes after spinal anesthesia End of the surgery (up to 1 hour) Postoperative 15 minutes Postoperative 30 minutes Postoperative 45 minutes Postoperative 60 minutes)
- Time Of First Analgesic Need(1 day after surgery)
- Urination Time(1 day after surgery)
- The Highest Dermatome Reached By The Sensory Block(intraoperative)
- Blood Pressure(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(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)
- S4 Dermatome Sensory Blockage Time(preoperative, intraoperative)
Investigators
semih başkan
principle investigator
Ankara City Hospital Bilkent