NCT01927874

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

August 23, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
8 months until next milestone

First Posted

Study publicly available on registry

August 23, 2013

Completed
2.2 years 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
Last Updated

February 3, 2016

Status Verified

February 1, 2016

Enrollment Period

2.8 years

First QC Date

August 23, 2012

Last Update Submit

February 2, 2016

Conditions

Hemorrhoid

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)

Infiltration, analgesic effect

ACTIVE COMPARATOR

10ml 0.5% bupivacaine each side Block Injection of local anesthetic at pudendal nerve

Procedure: InfiltrationDrug: Bupivacaine

Spinal block

ACTIVE COMPARATOR

10 mg of hyperbaric 0.5% bupivacaine Injection of anesthetic at subarachnoidal space

Procedure: Spinal blockDrug: 10 mg of hyperbaric 0.5% bupivacaine

Interventions

InfiltrationPROCEDURE

injection of local anesthetic, associated with general anesthesia

Also known as: Local Infiltration
Infiltration, analgesic effect
Spinal blockPROCEDURE

injection of anesthetic

Also known as: subarachnoidal block
Spinal block
BupivacaineDRUG

10ml 0.5% bupivacaine.

Also known as: Local infiltration
Infiltration, analgesic effect
10 mg of hyperbaric 0.5% bupivacaineDRUG

Spinal punction and injection of local anesthetic

Also known as: spinal anesthesia
Spinal block

Eligibility Criteria

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

You may qualify if:

  • Will be included 50 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

Study Sites (1)

Universidade Federal de São Paulo

São Paulo, São Paulo, 04044020, Brazil

Location

MeSH Terms

Conditions

HemorrhoidsPain, Postoperative

Interventions

Anesthesia, LocalAnesthesia, SpinalBupivacaine

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Rioko K Sakata, PhD

    Universidade Federal de São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

August 23, 2012

First Posted

August 23, 2013

Study Start

January 1, 2013

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

February 3, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)