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Morphine Added to Ropivacaine for FICB for Postoperative Analgesia

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
Nepal
Study Type
Interventional
Intervention
Ropivacaine, Morphine
Ropivacaine, Saline
Sponsored by
B.P. Koirala Institute of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • BPKIHS

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Ropivacaine group

Ropivacaine and morphine group

Arm Description

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

Ropivacaine 0.375% 20 ml + Morphine 2 ml via FICB

Outcomes

Primary Outcome Measures

Duration of Analgesia
The period in minutes when the patient is free of pain

Secondary Outcome Measures

Full Information

First Posted
February 1, 2019
Last Updated
June 14, 2022
Sponsor
B.P. Koirala Institute of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03875274
Brief Title
Morphine Added to Ropivacaine for FICB for Postoperative Analgesia
Official Title
Postoperative Analgesic Effect of Morphine Added to Ropivacaine for Fascia Iliaca Compartment Block Following Femoral Fracture Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
B.P. Koirala Institute of Health Sciences

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ropivacaine group
Arm Type
Placebo Comparator
Arm Description
Ropivacaine 0.375% 20 ml + Normal saline 2 ml via FICB
Arm Title
Ropivacaine and morphine group
Arm Type
Experimental
Arm Description
Ropivacaine 0.375% 20 ml + Morphine 2 ml via FICB
Intervention Type
Drug
Intervention Name(s)
Ropivacaine, Morphine
Intervention Description
Morphine added to ropivacaine for fascia iliaca compartment block
Intervention Type
Drug
Intervention Name(s)
Ropivacaine, Saline
Intervention Description
Normal saline added to ropivacaine for fascia iliaca compartment block
Primary Outcome Measure Information:
Title
Duration of Analgesia
Description
The period in minutes when the patient is free of pain
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
BPKIHS
City
Dharān Bāzār
State/Province
Sunsari
ZIP/Postal Code
977
Country
Nepal

12. IPD Sharing Statement

Plan to Share IPD
No

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Morphine Added to Ropivacaine for FICB for Postoperative Analgesia

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