Morphine Added to Ropivacaine for FICB for Postoperative Analgesia

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

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

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Ropivacaine, Saline; Drug: Ropivacaine, Morphine

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• Nepal
  • Sunsari
    • Dharān Bāzār, Sunsari, Nepal, 977
      • BPKIHS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Analgesia	The period in minutes when the patient is free of pain	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Rating Scale		0 hour, 4 hour, 8 hour, 12 hour, 24 hour
Ramsay Sedation Score		0 hour, 4 hour, 8 hour, 12 hour, 24 hour
Hemodynamics	Heart rate, blood pressure	0 hour, 4 hour, 8 hour, 12 hour, 24 hour

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: February 1, 2019
• First Submitted That Met QC Criteria: March 13, 2019
• First Posted (Actual): March 14, 2019

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Ropivacaine; Morphine
• Other Study ID Numbers: IRC/0832/016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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