Comparative Analysis of Hypobaric Versus Hyperbaric Bupivacaine for Spinal Anesthesia in Day-Case Anorectal Surgery

Comparative Analysis of Hypobaric Versus Hyperbaric Bupivacaine for Spinal Anesthesia in Day-Case Anorectal Surgery: Efficacy, Safety, and Discharge Times

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.

Study Overview

• Status: Completed
• Conditions: Hemorrhoids; Pilonidal Sinus; Anal Fissures; Anorectal Diseases; Anal Polyp
• Intervention / Treatment: Procedure: use of different spinal anesthesia 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.

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06800
    • Ankara City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Both sexes undergoing anorectal surgery, 18-65 years old, ASA score 1-2 patients

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Prospective

What is the study measuring?

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
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
Modified Bromage Scale	to determine the amount of motor function	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

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Study Director: Semih Başkan, Ankara Bilkent City Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): August 1, 2022

Study Registration Dates

• First Submitted: April 17, 2022
• First Submitted That Met QC Criteria: June 4, 2022
• First Posted (Actual): June 8, 2022

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 22, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Spinal Anesthesia; Day-case Surgery; Anorectal Surgery
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Neoplasms; Cysts; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Hemorrhoids; Rectal Diseases; Fissure in Ano; Pilonidal Sinus; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: ACH-YALNİZ-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No