Neostigmine as an Adjuvant in Tranversus Abdominis Plane (TAP) Block in Cesarean Section Under Spinal Anesthesia

ConditionAnalgesia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age19-40
SponsorMansoura University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bupivacaine-Neostigmine

    Drug

    20 mL bupivacaine 0.25% plus 1 mL Neostigmine (500 mcg)

  • Bupivacaine

    Drug

    20 mL bupivacaine 0.25% plus 1 mL normal saline 0.9%

Treatment groups

58 Participants
are divided into 2 treatment groups
Group A: Bupivacaine group (Group-B)Placebo comparator 1 intervention
Group B: Bupivacaine-Neostigmine group (Group-BN)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

The time of the first postoperative analgesic requirement

during the first 24 postoperative hours

Time frame
during the first 24 postoperative hours

Secondary outcomes

1

Total amount of the postoperative analgesic drugs (ketolac, paracetamol and fentanyl) consumed in the

mg

Time frame
during the first 24 postoperative hours
2

The visual analog scale (VAS) scores during rest

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

Time frame
during the first 24 postoperative hours
3

The visual analog scale (VAS) scores during movement

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

Time frame
during the first 24 postoperative hours
4

Mean arterial blood pressure (MBP)

mmHg

Time frame
basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Mansoura University-Emergency hospital-ICU Status unavailable 35511, El Mansoura, MansouraEgyptEgypt

Sponsors and contacts

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