Clinical trial NCT06568289: Lignocaine vs Bupivacaine Infiltration for Postpartum Perineal Pain After Vaginal Delivery With Episiotomy in Primigravidae
Official title: Lignocaine vs Bupivacaine Infiltration for Postpartum Perineal Pain After Vaginal Delivery With Episiotomy in Primigravidae: A Prospective Randomized, Double-Blind, Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lignocaine
Bupivacaine
Postpartum Perineal Pain
Vaginal Delivery
Episiotomy
Primigravidae
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-08-23
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 severe during the first few days after delivery, and it can lead to limitations in movement and difficulties with urination and defecation.

Bupivacaine is a long-acting local anesthetic that effectively reduces postoperative pain. In practice, bupivacaine is used for infiltration anesthesia, nerve blocks, epidural, and caudal anesthesia. It has a more selective effect on sensory nerve fibers as compared to motor nerve fibers, therefore is preferred in obstetrics.

Lignocaine infiltration, with the presence or absence of epidural anesthesia, is the most frequently employed local anesthetic in ameliorating postpartum perineal pain. It is a rapid-onset amide local anesthetic with a short duration of action lasting up to two hours.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Degree of pain
timeFrame: 6 hours postoperatively
Secondary outcomes:
measure: The time till first analgesic requirement
timeFrame: 6 hours postoperatively
measure: Total analgesics consumption
timeFrame: 12 hours postoperatively
measure: Incidence of compilation
timeFrame: 6 hours postoperatively
measure: Time of post-operative ambulation
timeFrame: 12 hours postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References: