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This randomized control trial aim to evaluate the effectiveness of local lidocaine spray application to the cervix on the reducing of pain score during the manual vacuum aspiration
This is a double blinded, placebo controlled study which compose of two arms. The treatment group is the local lidocaine spray application to the cervix with the intravenous opioid. The control group is the the intravenous opioid with the placebo (normal saline) before the manual vacuum aspiration. The outcome is to compare the visual analog pain score during and after procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10% lidocaine spray without adrenaline | Experimental | 4 puffs of 10% lidocaine spray without adrenaline apply on cervical os before manual vacuum aspiration |
|
| Placebo | Placebo Comparator | 4 puffs of normal saline apply on cervical os before manual vacuum aspiration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10 % lidocaine spray without adrenaline | Drug | Pateint with indication for manual vacuum aspiration aged between 20-60 years will received a standard injection of pethidine along with 1% lidocaine spray without adrenaline on cervical os to compare pain scores with placebo. Along with measuring side effects immediately and 30 minutes after receiving 1% lidocaine without adrenaline. |
| Measure | Description | Time Frame |
|---|---|---|
| pain score during manual vauum aspiration | The pain score using visual analog scale is used to assess the pain score during the manual vacuum aspiration during procedure (score 0-10), the 0 score is no pain and the 10 score is the maximum pain | during surgery |
| pain score after manual vauum aspiration | The pain score using visual analog scale is used to assess the pain score after the procedure (score 0-10) the 0 score is no pain and the 10 score is the maximum pain | at 30 minutes postoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| PATTARIKAN MANAYING | UdonThani Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UdonThani Hospital | Udon Thani | UdonThani | 41000 | Thailand |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 30, 2023 | Mar 20, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000073818 | Pain, Procedural |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
|
| Placebo | Other | 4 puffs of normal saline apply on cervical os before manual vacuum aspiration |
|
| D000588 |
| Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |