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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesic Effect of Morphine Added to Ropivacaine for Fascia Iliaca Compartment Block Following Femoral Fracture Surgeries
- ClinicalTrials.gov ID
- NCT03875274
- Acronym / sponsor ID
- IRC/0832/016
- Conditions
- Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- B.P. Koirala Institute of Health SciencesUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 14 Mar 2019 (actual)
- Results
- Posted 24 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
prospective, randomized double blinded study to investigate the effects of morphine as an adjuvant to ropivacaine on FICB
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine group | Placebo comparator | Drug: Ropivacaine, SalineRopivacaine 0.375% 20 ml + Normal saline 2 ml via FICB |
| Ropivacaine and morphine group | Experimental | Drug: Ropivacaine, MorphineRopivacaine 0.375% 20 ml + Morphine 2 ml via FICB |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients undergoing elective femur surgery under spinal anaesthesia
Key exclusion criteria (7 listed)
- • Not willing to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropivacaine, MorphineMorphine added to ropivacaine for fascia iliaca compartment block | Drug | Ropivacaine and morphine group |
| Ropivacaine, SalineNormal saline added to ropivacaine for fascia iliaca compartment block | Drug | Ropivacaine group |
Primary outcome
Duration of Analgesia
Time frame: 24 hours
The period in minutes when the patient is free of pain
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Analgesia (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.