Subarachnoid or Infiltration for Hemorrhoidectomy

Comparative Study of the Analgesic Effect of Subarachnoid or Infiltration for Hemorrhoidectomy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01927874

Enrollment

Registered

2013-08-23

Start date

2013-01-31

Completion date

2015-11-30

Last updated

2016-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemorrhoid

Keywords

infiltration, hemorrhoidectomy, Postoperative pain

Brief summary

There will be compared the postoperative analgesic effect of infiltration or spinal block for hemorrhoidectomy

Detailed description

This is a prospective, randomized study, including 40 patients between 18 and 60 years, of both genders, ASA 1 or 2. Patients in group 1 (n = 20) will be submitted to spinal block and group 2 (n = 20) to infiltration. The spinal block will be performed with 10 mg of 0.5% bupivacaine. The infiltration will be performed with 10 ml of 0.5% bupivacaine with epinephrine on each side. Will be evaluated: intensity of pain on a numerical scale from 0 to 10 every 15 minutes, relaxation of the sphincter muscles, intensity of pain after the operation every 30 minutes until reached the criteria for discharge, muscle strength of the lower limbs every 30 minutes, BP, HR, SO2, FR, other items that determine the conditions of discharge (urine output, nausea and vomiting), time to hospital discharge, and duration of analgesia. Adverse effects and complications will be noted.

Interventions

PROCEDUREInfiltration

injection of local anesthetic, associated with general anesthesia

PROCEDURESpinal block

injection of anesthetic

DRUGBupivacaine

10ml 0.5% bupivacaine.

DRUG10 mg of hyperbaric 0.5% bupivacaine

Spinal punction and injection of local anesthetic

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Will be included 50 patients, ASA physical status 1 or 2 undergoing hemorrhoidectomy after approval by the Ethics Committee and signed Consent Form

Exclusion criteria

* There will be excluded patients with associated diseases (fistula, fissure), infection at the puncture site, using anticoagulants or analgesics (up to 2 weeks before the procedure) and pregnant.

Design outcomes

Primary

Measure	Time frame	Description
Pain intensity	24 hours	Numerical score

Secondary

Measure	Time frame
Time to discharge	24 hours

Other

Measure	Time frame
Duration of motor blockade	24 hours

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026