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Included women were divided randomly into two groups:
Group A: (n=100): women were subjected to application of EMLA® cream "Lidocaine-prilocaine cream (EMLAcream; Astra Zeneca, Basiglio, Italy is an entectic mixture of 2.5% lidocaine and 2.5% prilocaine)"for pain relief during episiotomy repair.
Group B: (n=100): women were subjected to application of local injection of 10 ml of 1% mepivacaine for pain relief during episiotomy repair.
During the second stage of labor, women were placed in the lithotomy position. 10- Patients who were enrolled in the study were guaranteed to obtain additional anesthesia during episiotomy repair whenever pain exceeded the tolerability threshold.
11- Volunteers were assigned randomly to have either local injection of 10 ml of 1% mepivacaine or application of 5gm-dose® EMLA cream"Lidocaine- prilocaine cream(EMLA cream; Astra Zeneca, Basiglio, Italy is an entectic mixture of 2.5% lidocaine and 2.5% prilocaine)" for pain relief during episiotomy repair.
Group A: "EMLA group"
Group B: "mepivacaine infiltration group".
In the mepivacaine group, 10 ml of 1% mepivacaine solution was injected slowly when the fetal head was crowned with frequent aspiration to avoid intravascular injection.
In the mepivacaine group, if an episiotomy was indicated, it was performed after infiltration of perineal tissue with 10 ml of 1% mepivacaine solution.
The suture procedure was delayed 10 minutes after the injection of the aneathetic
All episiotomies were performed at the top of contraction as mediolateral episiotomies.
12- Episiotomy repair
In all cases episiotomies was repaired with a loose, continous, non locking suture to close the vaginal mucosa and the muscular layer of the perineum using vicryl Number zero (0).
The suture begins about 0.5 cms above the apex of the vaginal wound The suture are evenly placed to allow for approximation of the edges of the wound without causing tension or wrinkling or over lapping.
At the end of the vaginal mucosal repair care is taken to align the edges of the episiotomy wound to restore the appearance of the hymenal ring, the fourchette and the beginning of the perineal skin.
At the point where perineal skin begins; the suture is then passed beneath the vaginal mucosa, and repair of perineal muscle begins. The deep layer of muscles is closed first, ensuring no dead space one left behind, and ensuring no bleeding points are ignored.
The skin was closed with the same continuous suture to approximate the subcutinuous tissue.
The wound is cleared with antiseptic solution and covered by addressing. 14- Before leaving the delivery suite (approximately 2 hours after delivery) each patient was asked to record the severity of pain that she had experienced during perineal repair in a 10-cm visual analog scale, where 0 cm means no pain and 10 cm means unbearable pain.
The patient was asked to mark the point that best indicated the perception of her pain on the visual analog scale
Finally, women were asked to express their overall satisfaction with the anesthesia method during perineal repair with "yes" or "no" answers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine-prilocaine cream | Active Comparator | Women who were assigned randomly to receive EMLA cream had a 5gm dose of cream applied to the intact surface of the perineum and area covered with an occlusive dressing to facilitate pemetration thrug stratum corneum
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|
| mepivacaine infiltration group | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine-prilocaine cream | Drug | 5gm dose of cream applied to the intact surface of the perineum and area covered with an occlusive dressing to facilitate penetration - EMLA cream was applied, 1 hour before the expected time of birth. |
| Measure | Description | Time Frame |
|---|---|---|
| pain | The patient was asked to mark the point that best indicated the perception of her pain on the visual analog scale | 24 hours after delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed Maged, MD | Contact | 01005227404 | prof.ahmedmaged@gmail.com | |
| Ahmed Abd ElHak, MD | Contact | ah.abdelhak73@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed Maged, MD | kasr Alainy medical school | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasr Alainy medical school | Cairo | 12151 | Egypt |
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| mepivacaine infiltration group | Drug | 10 ml of 1% mepivacaine solution was injected slowly when the fetal head was crowned with frequent aspiration to avoid intravascular injection.
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| mediolateral episiotomy | Procedure | Episiotomy repair a loose, continous, non locking suture to close the vaginal mucosa and the muscular layer of the perineum using vicryl Number zero (0).
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| ID | Term |
|---|---|
| D000077442 | Lidocaine, Prilocaine Drug Combination |
| D008619 | Mepivacaine |
| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D011318 | Prilocaine |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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