Clinical trial NCT05785377: Neostigmine as an Adjuvant in Tranversus Abdominis Plane (TAP) Block in Cesarean Section Under Spinal Anesthesia
Official title: Efficacy of Neostigmine as an Adjuvant to Bupivacaine in Ultrasound-guided Transversus Abdominis Plane Block as a Postoperative Analgesia After Caesarean Delivery.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Analgesia
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 58
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: according to the computer-generated random number codes that will be placed in sealed envelopes, the patients will be randomly allocated into two groups; Group-B and Group-BN according tho the local anesthetic injected in Ultrasound-guided bilateral Tranversus abdominis plane block
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: The time of the first postoperative analgesic requirement
timeFrame: during the first 24 postoperative hours
Secondary outcomes:
measure: Total amount of the postoperative analgesic drugs (ketolac, paracetamol and fentanyl) consumed in the
timeFrame: during the first 24 postoperative hours
measure: The visual analog scale (VAS) scores during rest
timeFrame: during the first 24 postoperative hours
measure: The visual analog scale (VAS) scores during movement
timeFrame: during the first 24 postoperative hours
measure: Mean arterial blood pressure (MBP)
timeFrame: basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours
measure: heart rate (HR)
timeFrame: basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours
measure: Patient satisfaction about the quality of postoperative analgesia
timeFrame: during the first 24 postoperative hours
measure: The side effects (nausea, vomiting, abdominal colic and lower limb weakness)
timeFrame: during the first 24 postoperative hours
measure: the time from intrathecal injection till regression of spinal anesthesia to L2 dermatome
timeFrame: during the first 24 postoperative hours
Other outcomes:
Locations:
city: El Mansoura
country: Egypt
facility: Mansoura University-Emergency hospital-ICU
state: Mansoura
Study officials:
References: