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

NCT06568289 | Recruiting

• 1 other identifier: FMASUMS167/2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Lignocaine; Bupivacaine; Postpartum Perineal Pain; Vaginal Delivery; Episiotomy; Primigravidae

Outcome Measures

Primary Outcomes (1)

• Degree of pain

  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. Postoperative analgesic effect will be assessed using numeric version of the visual analogue scale (VAS) after delivery and local anesthetic infiltration (immediately after delivery, after 2 hours, after 4 hours, and after 6 hours).

  6 hours postoperatively

Secondary Outcomes (4)

• The time till first analgesic requirement

  6 hours postoperatively

• Total analgesics consumption

  12 hours postoperatively

• Incidence of compilation

  6 hours postoperatively

• Time of post-operative ambulation

  12 hours postoperatively

Study Arms (2)

Lignocaine group

EXPERIMENTAL

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.

Drug: Lignocaine

Bupivacaine group

EXPERIMENTAL

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.

Drug: Bupivacaine

Interventions

Lignocaine DRUG

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.

Lignocaine group

Bupivacaine DRUG

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.

Bupivacaine group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Primigravidae women with the full term undergoing vaginal delivery with episiotomy.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Lidocaine; Bupivacaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Mostafa M El Bukhari, MBBCH

CONTACT

00201002609476; mostafaserry15@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Captain Doctor, Resident of Obstetrics and Gynecology-The Police academy hospitals

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 23, 2024
• Study Start: March 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)