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

Sponsor
Federal University of São Paulo (Other)
Overall Status
Completed
CT.gov ID
NCT02839538
Collaborator
(none)
40
Enrollment
2
Arms
11
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Local Infiltration
  • Procedure: Subarachnoidal block
 Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Comparative Randomised Study of the Analgesic Effect of Local Infiltration or Spinal Block for Haemorrhoidectomy
Study Start Date :
Dec 1, 2014
Actual Primary Completion Date :
Nov 1, 2015
Actual Study Completion Date :
Nov 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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).

Procedure: Local Infiltration
Injection at perianal region with ropivacaine 0.75%(20ml)
Other Names:
  • local anesthesia

    		•
    Other: 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.

    Procedure: Subarachnoidal block
    Injection at subarachnoidal space with bupivacaine 0.5% ( 2ml)
    Other Names:
  • spinal anesthesia

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain intensity [24 hours]

      Numerical score

    Secondary Outcome Measures

    1. Time to discharge [24 hours]

    Other Outcome Measures

    1. Duration of motor blockade [24 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Federal University of São Paulo

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Luis Antonio Borges, MD, Federal University of São Paulo
    ClinicalTrials.gov Identifier:
    NCT02839538
    Other Study ID Numbers:
    • CAAE: 37140514.9.000.5505
    First Posted:
    Jul 21, 2016
    Last Update Posted:
    Jul 21, 2016
    Last Verified:
    Jul 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Luis Antonio Borges, MD, Federal University of São Paulo
    infiltration
    hemorrhoidectomy
    postoperative pain
    Additional relevant MeSH terms:
    Pain, Postoperative
    Anesthetics

    Study Results

    No Results Posted as of Jul 21, 2016