LignocaineNCT06568289
Lignocaine vs Bupivacaine Infiltration for Postpartum Perineal Pain After Vaginal Delivery With Episiotomy in Primigravidae
A study testing Lignocaine and Bupivacaine in people with Lignocaine and Bupivacaine, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Lignocaine, Bupivacaine, Postpartum Perineal Pain
- What is being tested?
- Lignocaine and Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo
Mostafa M El Bukhari, MBBCH, 00201002609476, mostafaserry15@gmail.com
Mohamed T Mahmoud, MD
About this study
Official title: Lignocaine vs Bupivacaine Infiltration for Postpartum Perineal Pain After Vaginal Delivery With Episiotomy in Primigravidae: A Prospective Randomized, Double-Blind, Clinical 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.
Read the detailed description
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.
- Conditions
- Lignocaine, Bupivacaine, Postpartum Perineal Pain, Vaginal Delivery, Episiotomy, Primigravidae
- Being tested
- Lignocaine, Bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LignocaineDrug
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.
BupivacaineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 hours postoperatively
Secondary outcomes (4)
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.
Measured: 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.
Measured: 12 hours postoperatively
Incidence of compilation
Incidence of compilation will be recorded such as as allergy, nausea, vomiting, fever, angioedema or respiratory distress.
Measured: 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.
Measured: 12 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start1 Mar 2024
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LignocaineStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Serry, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06568289
- Sponsor's protocol ID
- FMASUMS167/2024
- Status last verified
- Aug 2024
- First submitted
- 21 Aug 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lignocaine vs Bupivacaine Infiltration for Postpartum Perineal Pain After Vaginal Delivery With Episiotomy in Primigravidae: A Prospective Randomized, Double-Blind, Clinical Trial
- ClinicalTrials.gov ID
- NCT06568289
- Acronym / sponsor ID
- FMASUMS167/2024
- Conditions
- Lignocaine, Bupivacaine, Postpartum Perineal Pain, Vaginal Delivery, Episiotomy, Primigravidae
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 23 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lignocaine group | Experimental | Drug: LignocaineA 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 | Drug: BupivacaineA 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LignocaineA 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 group |
| BupivacaineA 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 group |
Primary outcome
Degree of pain
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).
4 secondary outcomes
The time till first analgesic requirement
Time frame: 6 hours postoperatively
Total analgesics consumption
Time frame: 12 hours postoperatively
Incidence of compilation
Time frame: 6 hours postoperatively
Time of post-operative ambulation
Time frame: 12 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lignocaine and Bupivacaine in people with Lignocaine and Bupivacaine, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mostafa M El Bukhari, MBBCH (00201002609476, mostafaserry15@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of pain (time frame: 6 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.