Clinical trial

Postoperative Analgesic Effect of Morphine Added to Ropivacaine for Fascia Iliaca Compartment Block Following Femoral Fracture Surgeries

Name

IRC/0832/016

Description

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

Trial arms

Trial start

2017-04-01

Estimated PCD

2017-12-31

Trial end

2017-12-31

Status

Completed

Phase

Early phase I

Treatment

Ropivacaine, Morphine

Morphine added to ropivacaine for fascia iliaca compartment block

Arms:

Ropivacaine and morphine group

Ropivacaine, Saline

Normal saline added to ropivacaine for fascia iliaca compartment block

Arms:

Ropivacaine group

Size

Primary endpoint

Duration of Analgesia

24 hours

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 70, 'type': 'ACTUAL'}}

Updated at

2023-03-24

1 organization

1 product

1 indication

Organization

B.P. Koirala Institute of Health Sciences

Product

Ropivacaine

Indication

Postoperative Pain