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prospective, randomized double blinded study to investigate the effects of morphine as an adjuvant to ropivacaine on FICB
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine group | Placebo Comparator | Ropivacaine 0.375% 20 ml + Normal saline 2 ml via FICB |
|
| Ropivacaine and morphine group | Experimental | Ropivacaine 0.375% 20 ml + Morphine 2 ml via FICB |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine, Morphine | Drug | Morphine added to ropivacaine for fascia iliaca compartment block |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Analgesia | The period in minutes when the patient is free of pain | 24 hours |
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Inclusion Criteria:
All patients undergoing elective femur surgery under spinal anaesthesia
Exclusion Criteria:
• Not willing to participate in the study
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BPKIHS | Dharān | Sunsari | 977 | Nepal |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ropivacaine Group | Ropivacaine 0.375% 20 ml + Normal saline 2 ml via FICB Ropivacaine, Saline: Normal saline added to ropivacaine for fascia iliaca compartment block |
| FG001 | Ropivacaine and Morphine Group | Ropivacaine 0.375% 20 ml + Morphine 2 ml via FICB Ropivacaine, Morphine: Morphine added to ropivacaine for fascia iliaca compartment block |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ropivacaine Group | Ropivacaine 0.375% 20 ml + Normal saline 2 ml via FICB Ropivacaine, Saline: Normal saline added to ropivacaine for fascia iliaca compartment block |
| BG001 | Ropivacaine and Morphine Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Duration of Analgesia | The period in minutes when the patient is free of pain | Posted | Mean | Standard Deviation | minutes | 24 hours |
|
24 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ropivacaine Group | Ropivacaine 0.375% 20 ml + Normal saline 2 ml via FICB Ropivacaine, Saline: Normal saline added to ropivacaine for fascia iliaca compartment block |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Pankaj Baral | BPKIHS | 9856037077 | pankajbaral7@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 1, 2016 | Jun 14, 2022 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D009020 | Morphine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Ropivacaine, Saline | Drug | Normal saline added to ropivacaine for fascia iliaca compartment block |
|
Ropivacaine 0.375% 20 ml + Morphine 2 ml via FICB
Ropivacaine, Morphine: Morphine added to ropivacaine for fascia iliaca compartment block
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Ropivacaine and Morphine Group | Ropivacaine 0.375% 20 ml + Morphine 2 ml via FICB Ropivacaine, Morphine: Morphine added to ropivacaine for fascia iliaca compartment block | 0 | 35 | 0 | 35 | 0 | 35 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |