Postoperative PainPhase 4NCT03875274
Morphine Added to Ropivacaine for FICB for Postoperative Analgesia
A Phase 4 study testing Ropivacaine, Morphine and Ropivacaine, Saline in people with Postoperative Pain, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
Trial summary
prospective, randomized double blinded study to investigate the effects of morphine as an adjuvant to ropivacaine on FICB Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Ropivacaine, Morphine and Ropivacaine, Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteNepal
- Study dates
- 1 Apr 2017to 31 Dec 2017
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing elective femur surgery under spinal anaesthesia
- Age group (18-65 years)
- ASA physical status I and II
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Postoperative Pain
- Being tested
- Ropivacaine, Morphine, Ropivacaine, Saline
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine, MorphineDrug
Morphine added to ropivacaine for fascia iliaca compartment block
Ropivacaine, SalineDrug
Normal saline added to ropivacaine for fascia iliaca compartment block
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine group | Placebo comparator | Ropivacaine 0.375% 20 ml + Normal saline 2 ml via FICB Receives: Drug: Ropivacaine, Saline |
| Ropivacaine and morphine group | Experimental | Ropivacaine 0.375% 20 ml + Morphine 2 ml via FICB Receives: Drug: Ropivacaine, Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Analgesia
The period in minutes when the patient is free of pain
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start1 Apr 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- B.P. Koirala Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pankaj Baral, B.P. Koirala Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03875274
- Sponsor's protocol ID
- IRC/0832/016
- Status last verified
- Jun 2022
- First submitted
- 1 Feb 2019
- Last updated
- 24 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No