NCT02537860

Brief Summary

This prospective double-blinded clinical trial is intended to compare three nerve stimulator- guided paravertebral block injections versus five injections for elderly patients undergoing hernia repair regarding intraoperative hemodynamic stability and postoperative pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2015

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 25, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 2, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2017

Completed
Last Updated

January 3, 2018

Status Verified

January 1, 2018

Enrollment Period

2.1 years

First QC Date

August 25, 2015

Last Update Submit

January 2, 2018

Conditions

Inguinal Hernia Repair

Outcome Measures

Primary Outcomes (1)

  • Mean arterial pressure (MAP) for hemodynamic stability

    Patients will be monitored during the operation, an expected average of 90 minutes

Secondary Outcomes (1)

  • Pain assessed through the Verbal Numeric Rating Scale (VNRS).

    5 postoperative days

Study Arms (2)

Three PVB injections

EXPERIMENTAL

Patients will receive three PVB injections from T12 to L2 and placebo at T11 and L3

Other: Paravertebral block injections from T12 to L2Other: Placebo at T11 and L3Procedure: HerniorrhaphyDrug: Intravenous (IV) fentanylDrug: Bupivacaine

Five PVB injections

EXPERIMENTAL

Patients will receive five PVB injections between T11 and L3.

Other: Paravertebral block injections between T11 and L3Procedure: HerniorrhaphyDrug: Intravenous (IV) fentanylDrug: Bupivacaine

Interventions

Paravertebral block injections from T12 to L2OTHER

Three anesthetic injections are done

Three PVB injections
Placebo at T11 and L3OTHER

Two injections that contain saline are performed

Three PVB injections
Paravertebral block injections between T11 and L3OTHER

Five anesthetic injections are done

Five PVB injections
HerniorrhaphyPROCEDURE

Unilateral inguinal hernia repair

Five PVB injectionsThree PVB injections
Intravenous (IV) fentanylDRUG

Patients will be given 1 μg/kg intravenous (IV) fentanyl as premedication

Five PVB injectionsThree PVB injections
BupivacaineDRUG

Each patient will receive 75 mg bupivacaine during PVB

Five PVB injectionsThree PVB injections

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • patients admitted to undergo elective unilateral inguinal hernia repair
  • patients with ASA II, III or IV

You may not qualify if:

  • bilateral inguinal hernia
  • incarcerated hernia
  • emergency cases
  • known history of allergic reactions to local anesthesia
  • bleeding disorders
  • neurological disorders
  • infection at site of injection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Makassed General Hospital

Beirut, Lebanon

Location

Related Publications (1)

  • Naja Z, Kanawati S, Khatib ZE, Ziade F, Nasreddine R, Naja AS. Three versus five lumbar paravertebral injections for inguinal hernia repair in the elderly: a randomized double-blind clinical trial. J Anesth. 2019 Feb;33(1):50-57. doi: 10.1007/s00540-018-2582-9. Epub 2018 Nov 16.

    PMID: 30446826DERIVED

MeSH Terms

Interventions

inulin trinicotinate monomethochlorideHerniorrhaphyFentanylBupivacaine

Intervention Hierarchy (Ancestors)

Plastic Surgery ProceduresSurgical Procedures, OperativePiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Zoher Naja

    Chairperson of Anesthesia department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairperson of Anesthesia and Pain Management Department

Study Record Dates

First Submitted

August 25, 2015

First Posted

September 2, 2015

Study Start

December 1, 2015

Primary Completion

December 30, 2017

Study Completion

December 30, 2017

Last Updated

January 3, 2018

Record last verified: 2018-01

Locations

LE(1)