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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Neostigmine as an Adjuvant to Bupivacaine in Ultrasound-guided Transversus Abdominis Plane Block as a Postoperative Analgesia After Caesarean Delivery.

Conditions
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Analgesia

Intervention / Treatment
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* Drug: Bupivacaine-Neostigmine
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Bupivacaine group (Group-B)<br>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 | Drug: Bupivacaine<br>* 20 mL bupivacaine 0.25% plus 1 mL normal saline 0.9%<br>|
| Active Comparator: Bupivacaine-Neostigmine group (Group-BN)<br>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 | Drug: Bupivacaine-Neostigmine<br>* 20 mL bupivacaine 0.25% plus 1 mL Neostigmine (500 mcg)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time of the first postoperative analgesic requirement | during the first 24 postoperative hours | during the first 24 postoperative hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total amount of the postoperative analgesic drugs (ketolac, paracetamol and fentanyl) consumed in the | mg | during the first 24 postoperative hours | 
| 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 | during the first 24 postoperative hours | 
| 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 | during the first 24 postoperative hours | 
| Mean arterial blood pressure (MBP) | mmHg | basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours | 
| heart rate (HR) | beat per minute | basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours | 
| Patient satisfaction about the quality of postoperative analgesia | poor = 1, fair = 2, good = 3, excellent = 4 | during the first 24 postoperative hours | 
| The side effects (nausea, vomiting, abdominal colic and lower limb weakness) | incidence | during the first 24 postoperative hours | 
| the time from intrathecal injection till regression of spinal anesthesia to L2 dermatome |  | during the first 24 postoperative hours |