Morphine Added to Ropivacaine for FICB for Postoperative Analgesia

NCT ID: NCT03875274

Last Updated: 2023-03-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2017-12-31

Brief Summary

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prospective, randomized double blinded study to investigate the effects of morphine as an adjuvant to ropivacaine on FICB

Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Ropivacaine group

Ropivacaine 0.375% 20 ml + Normal saline 2 ml via FICB

Group Type PLACEBO_COMPARATOR

Ropivacaine, Saline

Intervention Type DRUG

Normal saline added to ropivacaine for fascia iliaca compartment block

Ropivacaine and morphine group

Ropivacaine 0.375% 20 ml + Morphine 2 ml via FICB

Group Type EXPERIMENTAL

Ropivacaine, Morphine

Intervention Type DRUG

Morphine added to ropivacaine for fascia iliaca compartment block

Interventions

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Ropivacaine, Morphine

Morphine added to ropivacaine for fascia iliaca compartment block

Intervention Type DRUG

Ropivacaine, Saline

Normal saline added to ropivacaine for fascia iliaca compartment block

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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B.P. Koirala Institute of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Pankaj Baral

Junior Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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BPKIHS

Dharān, Sunsari, Nepal

Site Status

Countries

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Nepal

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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IRC/0832/016

Identifier Type: -

Identifier Source: org_study_id

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