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

NCT05409820 | Completed

• 1 other identifier: ACH-YALNİZ-001
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorectal Diseases; Hemorrhoids; Anal Polyp; Pilonidal Sinus; Anal Fissures

Keywords

Day-case Surgery; Spinal Anesthesia; Anorectal Surgery

Outcome Measures

Primary Outcomes (1)

• Discharge Time

  to determine the time at which patients are ready for discharge

  1 day after surgery

Secondary Outcomes (12)

• 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

• Mobilization Time

  1 day after surgery

• Postoperative Complication

  1 day after surgery

Interventions

use of different spinal anesthesia techniques PROCEDURE

Comparison of spinal anesthesia with 5 mg hypobaric bupivacaine and 5 mg hyperbaric bupivacaine in outpatients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 26614142 BACKGROUND

• 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.

  PMID: 21225292 BACKGROUND

MeSH Terms

Conditions

Rectal Diseases; Hemorrhoids; Pilonidal Sinus; Fissure in Ano

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Cysts; Neoplasms; Anus Diseases

Study Officials

• Semih Başkan

  Ankara City Hospital Bilkent

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: April 17, 2022
• First Posted: June 8, 2022
• Study Start: February 1, 2022
• Primary Completion: July 1, 2022
• Study Completion: August 1, 2022
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

TU (1)