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Paravertebral Block for Inguinal Hernia Repair in Elderly

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ClinicalTrials.gov Identifier: NCT02537860
Recruitment Status : Completed
First Posted : September 2, 2015
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
Zoher Naja, Makassed General Hospital

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.

Condition or disease Intervention/treatment Phase
Inguinal Hernia Repair Other: Paravertebral block injections from T12 to L2 Other: Placebo at T11 and L3 Other: Paravertebral block injections between T11 and L3 Procedure: Herniorrhaphy Drug: Intravenous (IV) fentanyl Drug: Bupivacaine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Paravertebral Block for Inguinal Hernia Repair in Elderly: Randomized Double-blinded Clinical Trial
Study Start Date : December 2015
Actual Primary Completion Date : December 30, 2017
Actual Study Completion Date : December 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Experimental: Three PVB injections
Patients will receive three PVB injections from T12 to L2 and placebo at T11 and L3
Other: Paravertebral block injections from T12 to L2
Three anesthetic injections are done

Other: Placebo at T11 and L3
Two injections that contain saline are performed

Procedure: Herniorrhaphy
Unilateral inguinal hernia repair

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

Drug: Bupivacaine
Each patient will receive 75 mg bupivacaine during PVB

Experimental: Five PVB injections
Patients will receive five PVB injections between T11 and L3.
Other: Paravertebral block injections between T11 and L3
Five anesthetic injections are done

Procedure: Herniorrhaphy
Unilateral inguinal hernia repair

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

Drug: Bupivacaine
Each patient will receive 75 mg bupivacaine during PVB




Primary Outcome Measures :
  1. Mean arterial pressure (MAP) for hemodynamic stability [ Time Frame: Patients will be monitored during the operation, an expected average of 90 minutes ]

Secondary Outcome Measures :
  1. Pain assessed through the Verbal Numeric Rating Scale (VNRS). [ Time Frame: 5 postoperative days ]


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02537860


Locations
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Lebanon
Makassed General Hospital
Beirut, Lebanon
Sponsors and Collaborators
Makassed General Hospital
Investigators
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Principal Investigator: Zoher Naja Chairperson of Anesthesia department
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Zoher Naja, Chairperson of Anesthesia and Pain Management Department, Makassed General Hospital
ClinicalTrials.gov Identifier: NCT02537860    
Other Study ID Numbers: 08252015
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal
Fentanyl
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General