About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Lignocaine
DrugA 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
DrugA 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.
Treatment groups
Trial outcomes
Primary outcomes
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).
Secondary outcomes
The time till first analgesic requirement
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 min if pain persists until the visual analogue scale \< 4. VAS will be assessed after delivery, after 2 hours, after 4 hours, and after 6 hours.
Total analgesics consumption
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 scale \< 4. VAS will be assessed after delivery, after 2 hours, after 4 hours, and after 6 hours.
Incidence of compilation
Incidence of compilation will be recorded such as as allergy, nausea, vomiting, fever, angioedema or respiratory distress.
Time of post-operative ambulation
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.
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