Clinical trial NCT05409820: Comparative Analysis of Hypobaric Versus Hyperbaric Bupivacaine for Spinal Anesthesia in Day-Case Anorectal Surgery
Official title: Comparative Analysis of Hypobaric Versus Hyperbaric Bupivacaine for Spinal Anesthesia in Day-Case Anorectal Surgery: Efficacy, Safety, and Discharge Times
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anorectal Diseases
Hemorrhoids
Anal Polyp
Pilonidal Sinus
Anal Fissures
Keywords: Day-case Surgery
Spinal Anesthesia
Anorectal Surgery
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Both sexes undergoing anorectal surgery, 18-65 years old, ASA score 1-2 patients

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:

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.

Eligibility criteria: 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

Primary outcomes:
measure: Discharge Time
timeFrame: 1 day after surgery
Secondary outcomes:
measure: Modified Bromage Scale
timeFrame: 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
measure: Time Of First Analgesic Need
timeFrame: 1 day after surgery
measure: Urination Time
timeFrame: 1 day after surgery
measure: Mobilization Time
timeFrame: 1 day after surgery
measure: Postoperative Complication
timeFrame: 1 day after surgery
measure: Blood Pressure
timeFrame: 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
measure: Heart Rate
timeFrame: 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
measure: Spo2
timeFrame: 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
measure: Number of Participants with Sedation Need
timeFrame: intraoperative, during surgery
measure: The Highest Dermatome Reached By The Sensory Block
timeFrame: intraoperative
measure: S4 Dermatome Sensory Blockage Time
timeFrame: preoperative, intraoperative
measure: Time to Disappearance of Sensory Block
timeFrame: 1 day after surgery
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Semih Başkan
role: STUDY_DIRECTOR
References:
citation: Honca M, Dereli N, Kose EA, Honca T, Kutuk S, Unal SS, Horasanli E. Low-dose levobupivacaine plus fentanyl combination for spinal anesthesia in anorectal surgery. Braz J Anesthesiol. 2015 Nov-Dec;65(6):461-5. doi: 10.1016/j.bjane.2014.01.007. Epub 2014 Feb 20.
citation: Taspinar V, Sahin A, Donmez NF, Pala Y, Selcuk A, Ozcan M, Dikmen B. Low-dose ropivacaine or levobupivacaine walking spinal anesthesia in ambulatory inguinal herniorrhaphy. J Anesth. 2011 Apr;25(2):219-24. doi: 10.1007/s00540-010-1089-9. Epub 2011 Jan 12.