Ain Shams University
Cairo, Egypt
Location status: Recruiting
Location contact
Ahmed M Hassan, MD
SUB_INVESTIGATOR
Ahmed M Mansour, MD
SUB_INVESTIGATOR
Mohamed T Mahmoud, MD
SUB_INVESTIGATOR
Mostafa M El Bukhari, MBBCH
CONTACT
NCT Number: NCT06568289
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.
Interested in participating?
Request Info18 year–40 year
Female
Interventional
Not applicable
Cairo, Egypt
Location status: Recruiting
Ahmed M Hassan, MD
SUB_INVESTIGATOR
Ahmed M Mansour, MD
SUB_INVESTIGATOR
Mohamed T Mahmoud, MD
SUB_INVESTIGATOR
Mostafa M El Bukhari, MBBCH
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 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.
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).
Time frame: 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 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.
Time frame: 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 scale < 4. VAS will be assessed after delivery, after 2 hours, after 4 hours, and after 6 hours.
Time frame: 6 hours postoperatively
Incidence of compilation will be recorded such as as allergy, nausea, vomiting, fever, angioedema or respiratory distress.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Ain Shams University
Other
Lignocaine vs Bupivacaine Infiltration for Postpartum Perineal Pain After Vaginal Delivery With Episiotomy in Primigravidae: A Prospective Randomized, Double-Blind, Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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