A Phase 4 interventional study of Lidocaine-prilocaine cream and mepivacaine infiltration group in Episiotomy Pain, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to female participants aged 19 Years to 39 Years. Per ClinicalTrials.gov, last updated 2017-08-29.
Sponsored by Cairo University · Phase 4, Interventional, and Prevention
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".
All episiotomies were performed at the top of contraction as mediolateral episiotomies.
12- Episiotomy repair
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 200 is above the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
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 * EMLA cream was applied, 1 hour before the expected time of birth. * With the assistance at birth, the residue of cream was removed to prevent contact with the fetus, because sodium hydroxide, which is a component of the cream, can cause fetal eye irritation. * No additional anesthetic was applied if episiotomy was necessary. * Before commancement of perineal repair any residual cream was wiped off.
Drug: Lidocaine-prilocaine cream · Procedure: mediolateral episiotomy
* 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
Drug: mepivacaine infiltration group · Procedure: mediolateral episiotomy
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.
Also known as: EMLA cream
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
Also known as: 1% mepivacaine
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). * At the end of the vaginal mucosal repair care is taken to align the edges of the episiotomy wound * 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 * The skin was closed with the same continuous suture to approximate the subcutinuous tissue.
pain
The patient was asked to mark the point that best indicated the perception of her pain on the visual analog scale
Time frame: 24 hours after delivery
Start is estimated for Aug 2017; primary completion for Mar 2018, 7 months later.
Of 280 non-industry phase 4 interventional studies under Pain, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 35. This study's planned 7 months is below that.
Counting every sponsor, half of 295 studies reached it within 18 months; a quarter within 8 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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