Neostigmine as an Adjuvant in Tranversus Abdominis Plane (TAP) Block in Cesarean Section Under Spinal Anesthesia
- Conditions
- Analgesia
- Interventions
- Drug: Bupivacaine-Neostigmine
- Registration Number
- NCT05785377
- Lead Sponsor
- Mansoura University
- Brief Summary
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 58
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bupivacaine group (Group-B) Bupivacaine After cession section, patients Will receive ultrasound (US)-guided bilateral TAP block with 20 mL bupivacaine 0.25% plus 1 mL of normal saline (Total volume of 21mL in each side Bupivacaine-Neostigmine group (Group-BN) Bupivacaine-Neostigmine After cession section, patients Will receive ultrasound (US)-guided bilateral TAP block with 20 mL bupivacaine 0.25% plus 1 mL of 500 mcg neostigmine (Total volume of 21mL in each side
- Primary Outcome Measures
Name Time Method The time of the first postoperative analgesic requirement during the first 24 postoperative hours during the first 24 postoperative hours
- Secondary Outcome Measures
Name Time Method Mean arterial blood pressure (MBP) basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours mmHg
The visual analog scale (VAS) scores during movement during the first 24 postoperative hours 11-point VAS (where 0 for no pain and 10 for the worst possible pain) at 0, 2, 4,6,12 and 24 hours postoperatively
Total amount of the postoperative analgesic drugs (ketolac, paracetamol and fentanyl) consumed in the during the first 24 postoperative hours mg
The visual analog scale (VAS) scores during rest during the first 24 postoperative hours 11-point VAS (where 0 for no pain and 10 for the worst possible pain) at 0, 2, 4,6,12 and 24 hours postoperatively
heart rate (HR) basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours beat per minute
the time from intrathecal injection till regression of spinal anesthesia to L2 dermatome during the first 24 postoperative hours The side effects (nausea, vomiting, abdominal colic and lower limb weakness) during the first 24 postoperative hours incidence
Patient satisfaction about the quality of postoperative analgesia during the first 24 postoperative hours poor = 1, fair = 2, good = 3, excellent = 4
Trial Locations
- Locations (1)
Mansoura University-Emergency hospital-ICU
🇪🇬El Mansoura, Mansoura, Egypt