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Sponsor study identifier
interventional
80
1 country
1
Study Start
October 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
January 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Episiotomy is a surgical cut made in the perineum, the area between the vagina and anus, during vaginal childbirth. Repairing an episiotomy can cause pain, and adequate pain relief is important for maternal comfort during and after delivery. This study will compare two methods of providing anesthesia during episiotomy repair in women undergoing vaginal delivery with a mediolateral episiotomy at the Department of Maternal and Child Health (MCH), Pakistan Institute of Medical Sciences (PIMS), Islamabad, Pakistan. A total of 80 eligible women will be enrolled and randomly assigned in equal numbers to two groups. The intervention group will receive a bilateral pudendal nerve block in addition to routine episiotomy repair and standard postpartum pain relief. The control group will receive conventional local anesthetic infiltration around the episiotomy area, along with routine repair and standard postpartum pain relief. Pain will be assessed using a 100-mm Visual Analogue Scale (VAS), on which 0 represents no pain and 100 represents the worst imaginable pain. Pain will be assessed during episiotomy repair and at 1, 3, and 6 hours after delivery. The study will also compare the need for additional pain medication, pain during sitting and walking, patient comfort and satisfaction, the duration of episiotomy repair, the need for additional local anesthetic, and complications associated with the procedures. The aim is to determine whether pudendal nerve block provides better pain relief during episiotomy repair and improves early postpartum comfort compared with conventional local anesthetic infiltration.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 13, 2026
Actual (reported)October 20, 2026
Actual (reported)October 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
February 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Pain intensity during episiotomy repair
Pain intensity will be measured using a 100-mm Visual Analogue Scale (VAS), where 0 represents no pain and 100 mm represents the worst imaginable pain. Pain will be assessed at predefined stages during episiotomy repair, including after anesthesia administration, at commencement of repair, during repair, and at completion of repair.
During episiotomy repair
Postpartum pain intensity
1, 3, and 6 hours postpartum
Requirement for rescue analgesia
First 6 hours postpartum
Patient satisfaction with pain management
1-6 hours postpartum
Participants will receive bilateral pudendal nerve block using 2% lidocaine, 2 mL, as specified in the study protocol. The procedure will be performed by an appropriately trained obstetrician or anesthetist using a standardized technique. Routine episiotomy repair and standard postpartum analgesia will also be provided.
Participants will receive conventional local perineal infiltration anesthesia according to the standard MCH PIMS episiotomy-repair protocol. Routine episiotomy repair and standard postpartum analgesia will be provided.
Bilateral pudendal nerve block performed using the standardized technique specified in the study protocol, with the local anesthetic described in the protocol (2% lidocaine, 2 mL). The procedure will be performed by an appropriately trained obstetrician or anesthetist, in addition to routine episiotomy repair and standard postpartum analgesia.
Conventional local anesthetic infiltration around the episiotomy site according to the standard MCH PIMS episiotomy-repair protocol. Routine episiotomy repair and standard postpartum analgesia will also be provided.
Department of Maternal and Child Health (MCH), Pakistan Institute of Medical Sciences (PIMS)
Islamabad, ICT, 04485, Pakistan
Aissaoui Y, Bruyere R, Mustapha H, Bry D, Kamili ND, Miller C. A randomized controlled trial of pudendal nerve block for pain relief after episiotomy. Anesth Analg. 2008 Aug;107(2):625-9. doi: 10.1213/ane.0b013e31817ee48f.
First Submitted
October 13, 2026
First Posted
Local anesthetic administered for bilateral pudendal nerve block at a dose of 2 mL, as specified in the study protocol.
Contact the study team to confirm eligibility.
October 20, 2026
Study Start
October 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
January 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 27, 2026
Record last verified: 2026-10
De-identified individual participant data collected during this study will not be shared with researchers outside the study team. Study data will be used for the planned analyses and reporting of study findings.
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Source: ClinicalTrials.gov.
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