Episiotomy , Perineal PainNCT07883473
Pudendal Nerve Block for Pain Relief During Episiotomy Repair
A study testing Pudendal Nerve Block, Conventional Local Perineal Infiltration and Lignocaine Hydrochloride (Lidocaine Hydrochloride) 2% injection in people with Episiotomy , Perineal Pain, run by Shaheed Zulfiqar Ali Bhutto Medical University at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Episiotomy , Perineal Pain
- What is being tested?
- Pudendal Nerve Block, Conventional Local Perineal Infiltration and Lignocaine Hydrochloride (Lidocaine Hydrochloride) 2% injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 31 Oct 2026to 15 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18 years or older
- Singleton pregnancy
- Vaginal delivery at MCH PIMS
- Requirement for mediolateral episiotomy
- Clinically uncomplicated episiotomy requiring routine repair
- Ability to understand the study information and provide written informed consent
Who cannot join
- Allergy or contraindication to the proposed local anesthetic
- Known coagulation disorder or significant bleeding tendency
- Local infection at the proposed injection site
- Associated third- or fourth-degree perineal tear
- Extensive vaginal or cervical laceration requiring additional anesthesia
- Major postpartum hemorrhage or another major postpartum complication requiring urgent management
Show all 9Show fewer
- Chronic pelvic or perineal pain, or regular use of analgesic medication before delivery
- Inability to understand the pain assessment scale or provide informed consent
- Failed pudendal nerve block despite appropriate technique
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zeenat Usman/Medical officier, MS obstetrics and gyanecology contact
Sobia Luqman/Assisstant Professor, FCPS obstetrics and gyane contact
Pakistan1 site
Department of Maternal and Child Health (MCH), Pakistan Institute of Medical Sciences (PIMS)
Islamabad, ICT, 04485
Zeenat Usman, MS obstetrics and Gyanecology, +923315333910, usmanbut2@gmail.com
Sobia Luqman, FCPS obstetrics and gyanecolog, +923348626904, sobialuqman8@gmail.com
About this study
Official title: Pudendal Nerve Block for Pain Relief During Episiotomy Repair: A Randomized Controlled Trial
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.
Read more
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.
Read the detailed description
Episiotomy is a surgical incision of the perineum performed during vaginal delivery and may be associated with pain during repair and in the early postpartum period. Conventional local perineal infiltration is commonly used to provide anesthesia during episiotomy repair; however, adequate pain relief may not always be achieved.
The pudendal nerve supplies sensory innervation to the vulva, lower vagina, perineum, and anus. Pudendal nerve block is a regional anesthetic technique that may provide effective analgesia during episiotomy repair. This study will evaluate the effectiveness of pudendal nerve block compared with conventional local perineal infiltration in women undergoing mediolateral episiotomy at the Department of Maternal and Child Health, Pakistan Institute of Medical Sciences (MCH PIMS), Islamabad.
Eligible women aged 18 years or older who undergo vaginal delivery with mediolateral episiotomy will be recruited after eligibility assessment and informed consent. Participants will be randomly allocated to one of two groups. The intervention group will receive bilateral pudendal nerve block using 2% lidocaine, in addition to routine episiotomy repair and standard postpartum analgesia. The control group will receive conventional local perineal infiltration according to the institutional protocol. Both groups will receive routine episiotomy repair and standard postpartum analgesia.
Pain intensity will be assessed using a 100-mm Visual Analogue Scale during episiotomy repair and at 1, 3, and 6 hours postpartum. Additional assessments will include the need for rescue analgesia, pain during sitting and walking, patient-reported comfort and satisfaction, duration of repair, requirement for additional local anesthetic, and the success or failure of the nerve block. Adverse events and complications associated with the procedures will also be documented.
The study aims to determine whether pudendal nerve block improves pain relief during episiotomy repair and early postpartum comfort compared with conventional local perineal infiltration. The findings may contribute to the local evidence base for pain management during episiotomy repair.
- Conditions
- Episiotomy , Perineal Pain
- Being tested
- Pudendal Nerve Block, Conventional Local Perineal Infiltration, Lignocaine Hydrochloride (Lidocaine Hydrochloride) 2% injection
- Keywords
- Pudendal nerve block Local anesthetic infiltration Postpartum pain Visual Analogue Scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pudendal Nerve BlockProcedure or surgery
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 Perineal InfiltrationProcedure or surgery
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.
Lignocaine Hydrochloride (Lidocaine Hydrochloride) 2% injectionDrug
Local anesthetic administered for bilateral pudendal nerve block at a dose of 2 mL, as specified in the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Pudendal Nerve Block Group | Experimental | 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. Receives: Procedure: Pudendal Nerve Block; Drug: Lignocaine Hydrochloride (Lidocaine Hydrochloride) 2% injection |
| Conventional Local Infiltration Group | Active comparator | 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. Receives: Procedure: Conventional Local Perineal Infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During episiotomy repair
Secondary outcomes (3)
Postpartum pain intensity
pain intensity measured using a 100-mm Visual Analogue Scale (VAS), where 0 represents no pain and 100 represents the worst imaginable pain.
Measured: 1, 3, and 6 hours postpartum
Requirement for rescue analgesia
Proportion of participants requiring additional analgesic medication for inadequate episiotomy-related pain relief.
Measured: First 6 hours postpartum
Patient satisfaction with pain management
Patient satisfaction with pain management assessed using a 5-point Likert scale, ranging from very dissatisfied to very satisfied.
Measured: 1-6 hours postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start31 Oct 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Episiotomy , Perineal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study uses a randomized, parallel-group design. Eligible women undergoing vaginal delivery with mediolateral episiotomy will be randomly allocated in a 1:1 ratio to one of two groups. The intervention group will receive bilateral pudendal nerve block in addition to routine episiotomy repair and standard postpartum analgesia. The control group will receive conventional local perineal infiltration with routine repair and standard postpartum analgesia. Participants will remain in their assigned groups throughout the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeenat Usman, Shaheed Zulfiqar Ali Bhutto Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07883473
- Sponsor's protocol ID
- F.1-1/2015/ERB/SZABMU/1634
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 18633043
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pudendal Nerve Block for Pain Relief During Episiotomy Repair: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07883473
- Acronym / sponsor ID
- F.1-1/2015/ERB/SZABMU/1634
- Conditions
- Episiotomy , Perineal Pain
- Keywords
- Pudendal nerve block Local anesthetic infiltration Postpartum pain Visual Analogue Scale
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical UniversityUniversity, hospital or other
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Episiotomy is a surgical incision of the perineum performed during vaginal delivery and may be associated with pain during repair and in the early postpartum period. Conventional local perineal infiltration is commonly used to provide anesthesia during episiotomy repair; however, adequate pain relief may not always be achieved.
The pudendal nerve supplies sensory innervation to the vulva, lower vagina, perineum, and anus. Pudendal nerve block is a regional anesthetic technique that may provide effective analgesia during episiotomy repair. This study will evaluate the effectiveness of pudendal nerve block compared with conventional local perineal infiltration in women undergoing mediolateral episiotomy at the Department of Maternal and Child Health, Pakistan Institute of Medical Sciences (MCH PIMS), Islamabad.
Eligible women aged 18 years or older who undergo vaginal delivery with mediolateral episiotomy will be recruited after eligibility assessment and informed consent. Participants will be randomly allocated to one of two groups. The intervention group will receive bilateral pudendal nerve block using 2% lidocaine, in addition to routine episiotomy repair and standard postpartum analgesia. The control group will receive conventional local perineal infiltration according to the institutional protocol. Both groups will receive routine episiotomy repair and standard postpartum analgesia.
Pain intensity will be assessed using a 100-mm Visual Analogue Scale during episiotomy repair and at 1, 3, and 6 hours postpartum. Additional assessments will include the need for rescue analgesia, pain during sitting and walking, patient-reported comfort and satisfaction, duration of repair, requirement for additional local anesthetic, and the success or failure of the nerve block. Adverse events and complications associated with the procedures will also be documented.
The study aims to determine whether pudendal nerve block improves pain relief during episiotomy repair and early postpartum comfort compared with conventional local perineal infiltration. The findings may contribute to the local evidence base for pain management during episiotomy repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study uses a randomized, parallel-group design. Eligible women undergoing vaginal delivery with mediolateral episiotomy will be randomly allocated in a 1:1 ratio to one of two groups. The intervention group will receive bilateral pudendal nerve block in addition to routine episiotomy repair and standard postpartum analgesia. The control group will receive conventional local perineal infiltration with routine repair and standard postpartum analgesia. Participants will remain in their assigned groups throughout the study.
| Arm | Type | Receives |
|---|---|---|
| Pudendal Nerve Block Group | Experimental | Procedure: Pudendal Nerve Block, Drug: Lignocaine Hydrochloride (Lidocaine Hydrochloride) 2% injectionParticipants 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. |
| Conventional Local Infiltration Group | Active comparator | Procedure: Conventional Local Perineal InfiltrationParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women aged 18 years or older
- Singleton pregnancy
- Vaginal delivery at MCH PIMS
- Requirement for mediolateral episiotomy
- Clinically uncomplicated episiotomy requiring routine repair
Key exclusion criteria (9 listed)
- Allergy or contraindication to the proposed local anesthetic
- Known coagulation disorder or significant bleeding tendency
- Local infection at the proposed injection site
- Associated third- or fourth-degree perineal tear
- Extensive vaginal or cervical laceration requiring additional anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pudendal Nerve BlockBilateral 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. | Procedure or surgery | Pudendal Nerve Block Group |
| Conventional Local Perineal InfiltrationConventional 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. | Procedure or surgery | Conventional Local Infiltration Group |
| Lignocaine Hydrochloride (Lidocaine Hydrochloride) 2% injectionLocal anesthetic administered for bilateral pudendal nerve block at a dose of 2 mL, as specified in the study protocol. | Drug | Pudendal Nerve Block Group |
Primary outcome
Pain intensity during episiotomy repair
Time frame: 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.
3 secondary outcomes
Postpartum pain intensity
Time frame: 1, 3, and 6 hours postpartum
Requirement for rescue analgesia
Time frame: First 6 hours postpartum
Patient satisfaction with pain management
Time frame: 1-6 hours postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Background: PubMed 18633043Aissaoui 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zeenat Usman/Medical officier, MS obstetrics and gyanecology contact
Sobia Luqman/Assisstant Professor, FCPS obstetrics and gyane contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pudendal Nerve Block, Conventional Local Perineal Infiltration and Lignocaine Hydrochloride (Lidocaine Hydrochloride) 2% injection in people with Episiotomy , Perineal Pain, run by Shaheed Zulfiqar Ali Bhutto Medical University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeenat Usman/Medical officier, MS obstetrics and gyanecology (+923315333910, usmanbut2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity during episiotomy repair (time frame: During episiotomy repair). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07883473, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.