Comparative Study of the Analgesic Effect of Spinal Anesthesia or Infiltration Anesthesia for Hemorrhoidectomy

Phase 4

Completed

• Conditions: Postoperative Pain
• Interventions: Procedure: Local Infiltration; Procedure: Subarachnoidal block

• Registration Number: NCT02839538
• Lead Sponsor: Federal University of São Paulo

Brief Summary

Background and Objectives: Postoperative analgesia and early recovery are relevant for hospital discharge after hemorrhoidectomy. This study investigated the postoperative analgesic effect with local infiltration compared with spinal block.

Methods: This randomized study included 40 patients aged 18 to 60 years old. Local group (LG) received local infiltration under general anaesthesia; spinal group (SG) received a subarachnoid block. LG received general anaesthesia with propofol, atracurium and propofol infusion as well as a local infiltration of 20 ml 0.75% ropivacaine. SG received 2 ml of 0.5% hyperbaric bupivacaine. Analgesic supplementation was with 50µg of fentanyl for LG and 1% lidocaine for SG. There were assessed: postoperative pain intensity, sphincter relaxation, motor blockade of lower limbs, time to discharge, analgesic dose over 1 week and adverse effects.

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= 19 ) will be submitted to spinal block and group 2 (n=21) to local infiltration. The spinal block will be performed with 10 mg of 0.5% bupivacaine. The infiltration will be performed with 10 ml of 0.75% ropivacaine on each side.

Will be evaluated: intensity of pain on a numerical scale from 0 to 10 every 30 minutes, relaxation of the sphincter muscles, intensity of pain after the operation every 30 minutes until reached the criteria for discharge, motor blocked 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.

Study Timeline

• Study Start: 2014-12
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-07
• Study First Submitted: 2016-07-06
• Study First Submitted QC: 2016-07-18
• Last Update Submitted: 2016-07-18
• Study First Posted: 2016-07-21
• Last Update Posted: 2016-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Will be included 40 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
local Infiltration	Local Infiltration	Induction of General Anesthesia with Propofol(2mg/Kg) and Atracurium(0,5mg/Kg) . Pulmonary ventilation with laryngeal mask and Propofol infusion ( 100mcg/Kg/min.) After , Infiltration of 0.75% ropivacaine (10 ml) each side block injection of local anesthetic at perianal. If necessary, fentanyl endovenous injection (50 mcg).
Subarachnoidal block	Subarachnoidal block	Sedation with midazolam 2 mg. After , Spinal block with 10 mg of hyperbaric 0.5% bupivacaine. Injection of anesthetic at subarachnoidal space with Quincke needle 27G. If pain, local infiltration with lidocaine 1% (5 ml) in wound.

Primary Outcome Measures

Name	Time	Method
Pain intensity	24 hours	Numerical score

Secondary Outcome Measures

Name	Time	Method
Time to discharge	24 hours