NCT05409820

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 80 (actual)
• Sponsor: Ankara City Hospital Bilkent · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	use of different spinal anesthesia techniques	Comparison of spinal anesthesia with 5 mg hypobaric bupivacaine and 5 mg hyperbaric bupivacaine in outpatients

Timeline

• Start date: 2022-02-01
• Primary completion: 2022-07-01
• Completion: 2022-08-01
• First posted: 2022-06-08
• Last updated: 2024-07-23

Locations

1 site across 1 country: Turkey (Türkiye)