NCT02839538

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_4 postoperative-pain

Timeline
Completed

Started Dec 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 21, 2016

Completed
Last Updated

July 21, 2016

Status Verified

July 1, 2016

Enrollment Period

11 months

First QC Date

July 6, 2016

Last Update Submit

July 18, 2016

Conditions

Postoperative Pain

Keywords

infiltrationhemorrhoidectomypostoperative pain

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    Numerical score

    24 hours

Secondary Outcomes (1)

  • Time to discharge

    24 hours

Other Outcomes (1)

  • Duration of motor blockade

    24 hours

Study Arms (2)

local Infiltration

ACTIVE COMPARATOR

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

Subarachnoidal block

OTHER

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

Interventions

Local InfiltrationPROCEDURE

Injection at perianal region with ropivacaine 0.75%(20ml)

Also known as: local anesthesia
local Infiltration
Subarachnoidal blockPROCEDURE

Injection at subarachnoidal space with bupivacaine 0.5% ( 2ml)

Also known as: spinal anesthesia
Subarachnoidal block

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Will be included 40 patients, ASA physical status 1 or 2 undergoing hemorrhoidectomy after approval by the Ethics Committee and signed Consent Form.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Borges LA, da Cunha Leal P, Rey Moura EC, Sakata RK. Randomized clinical study on the analgesic effect of local infiltration versus spinal block for hemorrhoidectomy. Sao Paulo Med J. 2017 May-Jun;135(3):247-252. doi: 10.1590/1516-3180.2017.0001260117. Epub 2017 May 29.

    PMID: 28562733DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, LocalAnesthesia, Spinal

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 6, 2016

First Posted

July 21, 2016

Study Start

December 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

July 21, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share