NCT01880775

Brief Summary

In this prospective randomized study the investigators aimed to investigate difference of the duration of spinal anesthesia, discharge times and efficacy between low dose heavy Prilocaine-Fentanyl and heavy Bupivacaine-Fentanyl in outpatient minor anal surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2012

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

March 12, 2012

Completed
20 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

June 19, 2013

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

June 3, 2014

Status Verified

March 1, 2012

Enrollment Period

1.2 years

First QC Date

March 12, 2012

Last Update Submit

June 2, 2014

Conditions

HemorrhoidPeri Anal Fistula

Outcome Measures

Primary Outcomes (1)

  • Sensory block regression at S3 (time, minute)

    spinal anesthesia

    postoperative 30. minute

Secondary Outcomes (1)

  • discharge time (minute)

    postoperative 2 hour

Other Outcomes (5)

  • Maximum block height

    Intraoperative 30 minutes

  • Motor block

    Intraoperative 30 minutes and postoperative first hour

  • Regression of motor block

    Postoperative second hour

  • +2 more other outcomes

Study Arms (2)

prilocaine heavy 2%& fentanyl

EXPERIMENTAL

prilocaine heavy 2% 30 mg and fentanyl 20 micgr ampoule intrathecal

Drug: Prilocaine

bupivacaine heavy 0.5% & fentanyl

ACTIVE COMPARATOR

bupivacaine heavy 0.5% 7.5 mg and fentanyl 20 micg ampoule intrathecal

Drug: Bupivacaine

Interventions

PrilocaineDRUG

experimental

Also known as: prilothecal, citanest
prilocaine heavy 2%& fentanyl
BupivacaineDRUG

marcaine heavy 0.5% 7.5 mg intrathecal

Also known as: marcaine heavy 0.5%
bupivacaine heavy 0.5% & fentanyl

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA status I-III

You may not qualify if:

  • Patients with contraindications for spinal anesthesia,
  • hypersensitivity to study drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diskapi Yildirim Beyazit Training and Research Hospital

Ankara, 06110, Turkey (Türkiye)

Location

Related Publications (3)

  • Camponovo C, Fanelli A, Ghisi D, Cristina D, Fanelli G. A prospective, double-blinded, randomized, clinical trial comparing the efficacy of 40 mg and 60 mg hyperbaric 2% prilocaine versus 60 mg plain 2% prilocaine for intrathecal anesthesia in ambulatory surgery. Anesth Analg. 2010 Aug;111(2):568-72. doi: 10.1213/ANE.0b013e3181e30bb8. Epub 2010 Jun 7.

    PMID: 20529983BACKGROUND

  • Black AS, Newcombe GN, Plummer JL, McLeod DH, Martin DK. Spinal anaesthesia for ambulatory arthroscopic surgery of the knee: a comparison of low-dose prilocaine and fentanyl with bupivacaine and fentanyl. Br J Anaesth. 2011 Feb;106(2):183-8. doi: 10.1093/bja/aeq272. Epub 2010 Oct 14.

    PMID: 20947591BACKGROUND

  • Ostgaard G, Hallaraker O, Ulveseth OK, Flaatten H. A randomised study of lidocaine and prilocaine for spinal anaesthesia. Acta Anaesthesiol Scand. 2000 Apr;44(4):436-40. doi: 10.1034/j.1399-6576.2000.440413.x.

    PMID: 10757577BACKGROUND

MeSH Terms

Conditions

Hemorrhoids

Interventions

PrilocaineBupivacaine

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Taylan Akkaya, Assoc Prof.

    Ministry of Health

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor Trainee in Anesthesiology and Reanimation

Study Record Dates

First Submitted

March 12, 2012

First Posted

June 19, 2013

Study Start

April 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

June 3, 2014

Record last verified: 2012-03

Locations

TU(1)