An observational study in Anorectal Diseases, Hemorrhoids and Anal Polyp, sponsored by Ankara City Hospital Bilkent. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-07-23.
Sponsored by Ankara City Hospital Bilkent · Observational
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.
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.
87 studies on the registry are indexed under Rectal Diseases; 14 are open to participants now.
This study's enrollment of 80 is below the median of 223 across 26 observational studies indexed under Rectal Diseases.
Browse Rectal Diseases studies →Ankara City Hospital Bilkent is the lead sponsor of 443 studies on the registry; 111 are open to participants now.
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Both sexes undergoing anorectal surgery, 18-65 years old, ASA score 1-2 patients
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Comparison of spinal anesthesia with 5 mg hypobaric bupivacaine and 5 mg hyperbaric bupivacaine in outpatients
Discharge Time
to determine the time at which patients are ready for discharge
Time frame: 1 day after surgery
Modified Bromage Scale
to determine the amount of motor function
Time frame: 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
to measure when the pain started
Time frame: 1 day after surgery
Urination Time
to determine the presence of urinary dysfunction
Time frame: 1 day after surgery
Mobilization Time
with a modified bromage scale of zero and able to walk unaided
Time frame: 1 day after surgery
Postoperative Complication
presence of headache, urinary dysfunction, postoperative nausea and vomiting
Time frame: 1 day after surgery
Blood Pressure
systolic, diastolic and mean arterial pressure,to determine the hemodynamic effects of spinal anesthesia
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: intraoperative, during surgery
The Highest Dermatome Reached By The Sensory Block
to determine whether sufficient sensory block has occurred
Time frame: intraoperative
S4 Dermatome Sensory Blockage Time
to determine the time it takes for adequate sensory block to occur for surgery
Time frame: preoperative, intraoperative
Time to Disappearance of Sensory Block
to calculate the duration of the effect of spinal anesthesia
Time frame: 1 day after surgery
Ran from Feb 2022 to primary completion in Jul 2022, 5 months.
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