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Adding sufentanyl to bupivacain in Transversus Abdominis Plane (TAP) block under ultrasound guide can reduce narcotic dosage, side effects and pain after cesarean delivery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sufentanyl group | Active Comparator | IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block |
|
| Control group | Placebo Comparator | In control group we add 1cc salin to 20cc bupivacain in TAP block |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sufentanyl | Drug | As intervention 1cc sufentanyl is added to bupivacain in case group for TAP block. As comparator 1cc normal saline is added to bupivacain in control group for Tap block. |
| Measure | Description | Time Frame |
|---|---|---|
| Narcotic Dosage | 24 h | |
| Narcotic Dosage | The total dosage of morphin consumed by the patients in sufentanil or control group. | over 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pain | 24h |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laleh Eslamian, MD | TUMS, Tehran University of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shariati hospital, TUMS | Tehran | 14114 | Iran |
Exclusions were based on exclusion criteria previously mentioned.
recruitment period: Jan 2012- Dec 2013 Shariati hospital, a tertiary center
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| ID | Title | Description |
|---|---|---|
| FG000 | Sufentanyl Group | IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block |
| FG001 | Control Group | In control group we add 1cc salin to 20cc bupivacain in TAP block |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
25 & 25
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| ID | Title | Description |
|---|---|---|
| BG000 | Sufentanyl Group | IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block |
| BG001 | Control Group | In control group we add 1cc salin to 20cc bupivacain in TAP block |
| 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 | Narcotic Dosage | Not Posted | 24 h | |||||||||||||
| Secondary | Pain | Not Posted | 24h | |||||||||||||
24h
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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 | Sufentanyl Group | IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea and vomiting | Gastrointestinal disorders | SNOMED CT | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| itching | Skin and subcutaneous tissue disorders | SNOMED CT | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Laleh Eslamian | Tehran University of Medical Sciences | 0098218490 | 2415 | leslamian@tums.ac.ir |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017409 | Sufentanil |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Narcotic Dosage |
The total dosage of morphin consumed by the patients in sufentanil or control group. |
| Posted |
| Mean |
| Standard Deviation |
| mgm,. |
| over 24 hours after surgery |
|
|
|
| 1 |
| 25 |
| 0 |
| 25 |
| EG001 | Control Group | In control group we add 1cc salin to 20cc bupivacain in TAP block | 3 | 25 | 1 | 25 |
| itching | Skin and subcutaneous tissue disorders | SNOMED CT | Non-systematic Assessment |
|
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