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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Primigravidae women with the full term undergoing vaginal delivery with episiotomy.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mostafa M El Bukhari, MBBCH | Contact | 00201002609476 | mostafaserry15@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University | Recruiting | Cairo | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
After the end of study for one year.
The data will be available upon a reasonable request from the corresponding author.
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|
| 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. |
|
| 6 hours postoperatively |
| 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. | 12 hours postoperatively |
| Incidence of compilation | Incidence of compilation will be recorded such as as allergy, nausea, vomiting, fever, angioedema or respiratory distress. | 6 hours postoperatively |
| 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. | 12 hours postoperatively |
| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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