Urine Retention Rate Between Spinal and General Anesthesia for Anorectal Surgery

Anorectal Disorder Clinical Trial

Official title:

Pain Score and Urine Retention Rate Between Spinal and General Anesthesia for Anorectal Surgery, Retrospective Observation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05571202
• Other study ID #: CG22204A
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: September 30, 2022

Study information

• Verified date: January 2023
• Source: Taichung Veterans General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1400
• Est. completion date: September 30, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anorectal Disorder
• Rectal Diseases

Intervention

Procedure:
• General anesthesia plus local infiltration
The eligible patients underwent anorectal surgery under general anesthesia (GE, GM, IVG) plus locally injected analgesics.
• Spinal anesthesia
The eligible patients underwent anorectal surgery under spinal anesthesia alone.

Locations

Country	Name	City	State
Taiwan	Taichung Verterans General Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine retention rate	urine retention events needs foley catheterization	0-24 hours post operation.
Primary	Pain score	Visual Analogue Scale (VAS)	0-24 hours post operation.
Secondary	surgery complications	surgery complications	0-30 days post operative days.
Secondary	anesthesia complications	anesthesia complications rate	0-30 days post operative days.