Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT03264586 |
| Other study ID # |
9 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 4
|
| First received |
August 25, 2017 |
| Last updated |
August 25, 2017 |
| Start date |
August 2017 |
| Est. completion date |
March 2018 |
Study information
| Verified date |
August 2017 |
| Source |
Cairo University |
| Contact |
Ahmed Maged, MD |
| Phone |
01005227404 |
| Email |
prof.ahmedmaged[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
1. Group A: "EMLA group"
- 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.
2. 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
