Neostigmine as an Adjuvant in Tranversus Abdominis Plane (TAP) Block in Cesarean Section Under Spinal Anesthesia
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bupivacaine-Neostigmine, Bupivacaine.
- Who it may be relevant to
- Registry conditions: Analgesia. Basic parameters: 19 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Neostigmine as an Adjuvant to Bupivacaine in Ultrasound-guided Transversus Abdominis Plane Block as a Postoperative Analgesia After Caesarean Delivery.
Overview
Cesarean birth is a common surgical procedure. After cesarean birth, postsurgical pain may delay recovery, interfere with maternal-newborn bonding, and reduce the breastfeeding if not adequately controlled. Postpartum analgesia has become a common concern. Many adjuvant drugs used for peripheral nerve blocks as( N-methyl-d-aspartate (NMDA) receptor antagonists , Magnesium , Ephedrine , Dexamesathone , Fentanyl , Midazolam and Neostigmine) The potential of neostigmine as an adjuvant in peripheral nerve block is through its action to increase acetylcholine at muscarinic junctions of peripheral nerves. 500 mcg neostigmine was used as adjuvant to local anesthetic in an axillary brachial plexus block leads to decreased pain and less use of analgesics in the first 24 hours postoperatively with no incidence of adverse effects.
Detailed description
This prospective double-blinded randomized controlled study will be done on parturients that are scheduled for elective cesarean delivery under spinal anesthesia to assess the efficacy of neostigmine as an adjuvant to isobaric bupivacaine inTranversus abdominis plane (TAPB) for postoperative analgesia in cesarean section under spinal anesthesia.
Interventions
- Drug Bupivacaine-Neostigmine
20 mL bupivacaine 0.25% plus 1 mL Neostigmine (500 mcg) - Drug Bupivacaine
20 mL bupivacaine 0.25% plus 1 mL normal saline 0.9%
Primary outcome measures
- The time of the first postoperative analgesic requirement [Time frame: during the first 24 postoperative hours]
Secondary outcome measures (8)
- Total amount of the postoperative analgesic drugs (ketolac, paracetamol and fentanyl) consumed in the [Time frame: during the first 24 postoperative hours]
- The visual analog scale (VAS) scores during rest [Time frame: during the first 24 postoperative hours]
- The visual analog scale (VAS) scores during movement [Time frame: during the first 24 postoperative hours]
- Mean arterial blood pressure (MBP) [Time frame: basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours]
- heart rate (HR) [Time frame: basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours]
- Patient satisfaction about the quality of postoperative analgesia [Time frame: during the first 24 postoperative hours]
- The side effects (nausea, vomiting, abdominal colic and lower limb weakness) [Time frame: during the first 24 postoperative hours]
- the time from intrathecal injection till regression of spinal anesthesia to L2 dermatome [Time frame: during the first 24 postoperative hours]
Eligibility criteria
Inclusion criteria
- Age from 19 to 40 years old
- American Society of Anesthesiologists (ASA) physical status II patients
- Singleton pregnancies with a gestational age of at least 37 weeks.
- Patients undergoing spinal anesthesia for cesarean delivery via a Pfannenstiel incision with exteriorization of the uterus.
Exclusion criteria
- Age < 19 or > 40 years.
- Height<150 cm, weight < 60 kg, body mass index (BMI) ≥40 kg/m2.
- Inability to comprehend or participate in the pain scoring system.
- Contraindications to spinal anesthesia (Coagulopathy, increased intracranial pressure, or local skin infection).
- Hypersensitivity to any drug used in the study.
- Any hypertensive disorders of pregnancy.
- Renal impairment or other contraindications to non-steroidal anti-infilamatory drugs (NSAIDS).
- Significant cardiovascular, renal or hepatic abnormalities.
- Patients with history of opioid intake, drug abusers or psychiatric patients
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Mansoura University-Emergency hospital-ICU — El Mansoura
Identifiers
NCT: NCT05785377 · TAP-neostigmine