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Morphine Added to Ropivacaine for FICB for Postoperative Analgesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03875274
Recruitment Status : Completed
First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Pankaj Baral, B.P. Koirala Institute of Health Sciences

Study Description
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Brief Summary:
prospective, randomized double blinded study to investigate the effects of morphine as an adjuvant to ropivacaine on FICB

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Ropivacaine, Morphine Drug: Ropivacaine, Saline Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Postoperative Analgesic Effect of Morphine Added to Ropivacaine for Fascia Iliaca Compartment Block Following Femoral Fracture Surgeries
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Ropivacaine group
Ropivacaine 0.375% 20 ml + Normal saline 2 ml via FICB
 Drug: Ropivacaine, Saline
Normal saline added to ropivacaine for fascia iliaca compartment block
Experimental: Ropivacaine and morphine group
Ropivacaine 0.375% 20 ml + Morphine 2 ml via FICB
 Drug: Ropivacaine, Morphine
Morphine added to ropivacaine for fascia iliaca compartment block


Outcome Measures
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Primary Outcome Measures :
  1. Duration of analgesia [ Time Frame: 24 hours ]
    The period in minutes when the patient is free of pain

  2. Requirement of postoperative opioids [ Time Frame: 24 hours ]
    milligram of tramadol


Secondary Outcome Measures :
  1. Numeric Rating Scale [ Time Frame: 0 hour, 4 hour, 8 hour, 12 hour, 24 hour ]
  2. Ramsay Sedation Score [ Time Frame: 0 hour, 4 hour, 8 hour, 12 hour, 24 hour ]
  3. Hemodynamics [ Time Frame: 0 hour, 4 hour, 8 hour, 12 hour, 24 hour ]
    Heart rate, blood pressure


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients undergoing elective femur surgery under spinal anaesthesia

    • Age group (18-65 years)
    • ASA physical status I and II

Exclusion Criteria:

  • • Not willing to participate in the study

    • Other painful co-morbidities (neuropathies)
    • Allergy or any contraindication to study medication
    • Psychiatric disorder
    • Coagulopathy
    • Infection at the site of the block
    • Use of other modes of anaesthesia or analgesia besides spinal anaesthesia.
Contacts and Locations
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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): NCT03875274


Locations
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Nepal
BPKIHS
Dharān Bāzār, Sunsari, Nepal, 977
Sponsors and Collaborators
B.P. Koirala Institute of Health Sciences
More Information
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Responsible Party: Pankaj Baral, Junior Resident, B.P. Koirala Institute of Health Sciences
ClinicalTrials.gov Identifier: NCT03875274    
Other Study ID Numbers: IRC/0832/016
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Morphine
Ropivacaine
Analgesics, Opioid
 Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local
Anesthetics