Comparing Lignocaine and Bupivacaine for Pain Relief After Vaginal Delivery with Episiotomy
Lignocaine vs Bupivacaine Infiltration for Postpartum Perineal Pain After Vaginal Delivery With Episiotomy in Primigravidae: A Prospective Randomized, Double-Blind, Clinical Trial
This study is testing whether lignocaine or bupivacaine works better for relieving pain after vaginal delivery with an episiotomy in first-time mothers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06568289 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness and safety of lignocaine versus bupivacaine infiltration for managing postpartum perineal pain in first-time mothers who undergo vaginal delivery with episiotomy. Episiotomy, while beneficial for childbirth, can lead to significant pain and complications. Bupivacaine is a long-acting anesthetic preferred for its selective effect on sensory nerves, while lignocaine is a rapid-onset anesthetic with a shorter duration. The trial aims to determine which anesthetic provides better pain relief and safety for patients.
Who should consider this trial
Good fit: Ideal candidates are first-time mothers (primigravidae) who are undergoing vaginal delivery with episiotomy.
Not a fit: Patients with a history of drug allergies to the study medications or those receiving epidural or spinal anesthesia will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for postpartum women, enhancing their recovery and quality of life.
How similar studies have performed: Previous studies have shown varying success with local anesthetics for postpartum pain management, but this specific comparison of lignocaine and bupivacaine is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cairo
- Ain Shams University — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Mostafa M El Bukhari, MBBCH
- Email: mostafaserry15@gmail.com
- Phone: 00201002609476
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.