Urine Retention Rate Between Spinal and General Anesthesia for Anorectal Surgery

Completed

• Conditions: Anorectal Disorder
• Interventions: Procedure: Spinal anesthesia; Procedure: General anesthesia plus local infiltration

• Registration Number: NCT05571202
• Lead Sponsor: Taichung Veterans General Hospital

Brief Summary

Anorectal surgery includes pilonidal sinus, hemorrhoidectomy, anal fissure, and anal fistula operations. General and spinal anesthesia were common anesthetic methods in anorectal surgery. We designed this study to test the hypothesis that general anesthesia was superior than spinal anesthesia with respect to urine retention rate, pain score, recovery time, and side effects.

Detailed Description

Anorectal surgery includes pilonidal sinus, hemorrhoidectomy, anal fissure, and anal fistula operations. Deep level of anesthesia is required for these surgeries. Excellent operation conditions and rapid recovery is anticipated for optimal anesthesia. Various surgical and anesthetic techniques, including spinal anesthesia, general anesthesia and local infiltration have been used to increase the level of patients' perioperative analgesia and decrease the length of stay in the hospital. Among them, general and spinal anesthesia were common anesthetic methods in anorectal surgery. We designed this study to test the hypothesis that general anesthesia was superior than spinal anesthesia with respect to urine retention rate, pain score, recovery time, and side effects.

Inclusion Criteria:

* \>20 years old patients

* ASA 1-2 patients

* Patients who will undergo anorectal surgery with including hemorrhoidectomy, fistulectomy, fistulotomy, fissurectomy and anoplasty.

Exclusion Criteria:

* Having known hypersensitivity to amide type local anesthetics

* Patients ASA \>=3

* Surgery methods: hemorrhoidopexy, Laser hemorrhoidoplasty

* Fournier gangrene patients

* Surgery due to previous complications.

Characteristic data

1. Age, Gender, ASA class,

2. Past history: medical history, surgical history

3. Previous anorectal history

4. Type of anorectal surgery, number of hemorrhoidectomy

5. Methods of anesthesia, posture during surgery

6. Postoperative recovery room record: vital sign, Post Anaesthetic Discharge Scoring System (0-10, \>9 can discharge)

7. Ward record: vital sign and urine retention need foley catherization

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2022-05-30
• Study Completion: 2022-09-30
• Study First Submitted: 2022-10-05
• Study First Submitted QC: 2022-10-05
• Study First Posted: 2022-10-07
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-27
• Last Update Posted: 2023-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1400

Inclusion Criteria

• >20 years old patients
• ASA 1-2 patients
• Patients who will undergo anorectal surgery with including hemorrhoidectomy, fistulectomy, fistulotomy, fissurectomy and anoplasty.

Exclusion Criteria

• Having known hypersensitivity to amide type local anesthetics
• Patients ASA >=3
• Surgery methods: hemorrhoidopexy, Laser hemorrhoidoplasty
• Fournier gangrene patients
• Surgery due to previous complications

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Anorectal surgery patient under spinal anesthesia	Spinal anesthesia	Anorectal surgery patient under spinal anesthesia alone
Anorectal surgery patient under general anesthesia plus local infiltration	General anesthesia plus local infiltration	Anorectal surgery patient under general anesthesia plus local infiltration

Primary Outcome Measures

Name	Time	Method
Urine retention rate	0-24 hours post operation.	urine retention events needs foley catheterization
Pain score	0-24 hours post operation.	Visual Analogue Scale (VAS)

Secondary Outcome Measures

Name	Time	Method
surgery complications	0-30 days post operative days.	surgery complications
anesthesia complications	0-30 days post operative days.	anesthesia complications rate

Trial Locations

Locations (1)

Taichung Verterans General Hospital; 🇨🇳 Taichung, Taiwan