Morphine Added to Ropivacaine for FICB for Postoperative Analgesia

NCT03875274 | Completed Phase 4 Results DMC

• 1 other identifier: IRC/0832/016
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Duration of Analgesia

  The period in minutes when the patient is free of pain

  24 hours

Study Arms (2)

Ropivacaine group

PLACEBO COMPARATOR

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

Drug: Ropivacaine, Saline

Ropivacaine and morphine group

EXPERIMENTAL

Ropivacaine 0.375% 20 ml + Morphine 2 ml via FICB

Drug: Ropivacaine, Morphine

Interventions

Ropivacaine, Morphine DRUG

Morphine added to ropivacaine for fascia iliaca compartment block

Ropivacaine and morphine group

Ropivacaine, Saline DRUG

Normal saline added to ropivacaine for fascia iliaca compartment block

Ropivacaine group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients undergoing elective femur surgery under spinal anaesthesia
• Age group (18-65 years)
• ASA physical status I and II

You may not qualify if:

• 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.

Sponsors & Collaborators

• B.P. Koirala Institute of Health Sciences: lead

Study Sites (1)

BPKIHS

Dharān, Sunsari, 977, Nepal

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine; Morphine; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Pankaj Baral
• Organization: BPKIHS

pankajbaral7@gmail.com

9856037077

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior Resident

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: March 14, 2019
• Study Start: April 1, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: March 24, 2023
• Results First Posted: March 24, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)