Lignocaine vs Bupivacaine Infiltration for Postpartum Perineal Pain After Vaginal Delivery With Episiotomy in Primigravidae

Not Applicable

Recruiting

• Conditions: Postpartum Perineal Pain; Episiotomy; Vaginal Delivery; Primigravidae; Bupivacaine; Lignocaine
• Interventions: Drug: Lignocaine; Drug: Bupivacaine

• Registration Number: NCT06568289
• Lead Sponsor: Ain Shams University

Brief Summary

In this study, we will compare the effect and safety of lignocaine versus bupivacaine infiltration for postpartum perineal pain after vaginal delivery with episiotomy in primigravidae.

Detailed Description

Episiotomy is the most common procedure used for dilatation of the vaginal opening for giving birth. Although episiotomy is associated with benefits for the mother, it may lead to short term and long-term disabilities, including postpartum perineal pain that is secondary to perineal tearing. The perineal pain experienced due to receiving an episiotomy is sev...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2024-03-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-21
• Study First Submitted QC: 2024-08-22
• Last Update Submitted: 2024-08-22
• Study First Posted: 2024-08-23
• Last Update Posted: 2024-08-23
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Primigravidae with the full term undergoing vaginal delivery with episiotomy.
• Pregnancies and singleton vertex cephalic fetuses.
• In the active phase of the first stage of labor.

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Exclusion Criteria

• Patients with history of drug allergies to study drugs as this will increase the risk of complications.
• Patients undergoing vaginal delivery under epidural or spinal anesthesia as they will affect post-operative pain and interfere with assessment of efficacy of local infiltration of the study drugs.
• Evidence of local infection at site of injection as this will interfere with the action of the study drug and will increase the risk of complications.
• Inability to cooperate as this will affect our assessment.
• Patient's refusal.
• Any intraoperative complications that will affect our outcome criteria (bleeding, organ injury) as they will affect patient's vital data and affect our assessment.
• Neurological comorbidities (chronic pain disorder, chronic systemic disease, neurological disorder, neuropathic pain) as they will need more analgesia.
• Drug abuse as they will be tolerant to the used analgesics.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lignocaine group	Lignocaine	A perineal infiltration of a 5-ml of the drug (100 mg of lignocaine) in the margins of the episiotomy. Careful aspiration before and during injection of the product should be performed to prevent intravascular injection. The entire contents will then be injected slowly at several points of infiltration. All planes will be infiltrated (vagina, muscle, and skin) before episiotomy repair.
Bupivacaine group	Bupivacaine	A perineal infiltration of a 5-ml of the study drug (20 mg of Bupivacaine) in the margins of the episiotomy. Careful aspiration before and during injection of the product should be performed to prevent intravascular injection. The entire contents will then be injected slowly at several points of infiltration. All planes will be infiltrated (vagina, muscle, and skin) before episiotomy repair.

Primary Outcome Measures

Name	Time	Method
Degree of pain	6 hours postoperatively	Degree of pain will be assessed using the visual analogue scale (VAS) is the scale that will be used to assess postoperative pain and its intensity. A respondent will select a whole number (0- 10 integers) that best reflects the intensity of her pain, 1-10 will be recorded.; ...

Secondary Outcome Measures

Name	Time	Method
Incidence of compilation	6 hours postoperatively	Incidence of compilation will be recorded such as as allergy, nausea, vomiting, fever, angioedema or respiratory distress.
Time of post-operative ambulation	12 hours postoperatively	Post-operative ambulation enhancement in the form of time of start of ambulation (in hours) starting from end of surgery- walking- climbing stairs will be recorded.
The time till first analgesic requirement	6 hours postoperatively	The time till first analgesic (non-steroidal anti-inflammatory drugs (NSAIDs) requirement which is defined as the time (immediately after delivery, after 2 hours, after 4 hours and after 6 hours) after delivery and local anesthetic infiltration. Rescue analgesia of morphine will be given as 3 mg bolus if the visual analogue scale \> 3 to be repeated after 30...
Total analgesics consumption	12 hours postoperatively	Total analgesics consumption over 12-hour period post-operative with mentioning the number and time of drugs given and the total dose of each drug post-operative (presented by hours post-operative).Rescue analgesia of morphine will be given as 3 mg bolus if the visual analogue scale \> 3 to be repeated after 30 min if pain persists until the visual analogue ...

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt