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

NCT ID: NCT05785377

Last Updated: 2024-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2027-03-01

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.

Conditions

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Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
The injectate used for TAPB will be prepared according to the group by an anesthesiologist who won't be involved in the data collection

Study Groups

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Bupivacaine group (Group-B)

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

Group Type PLACEBO_COMPARATOR

Bupivacaine

Intervention Type DRUG

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

Bupivacaine-Neostigmine group (Group-BN)

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

Group Type ACTIVE_COMPARATOR

Bupivacaine-Neostigmine

Intervention Type DRUG

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

Interventions

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Bupivacaine-Neostigmine

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

Intervention Type DRUG

Bupivacaine

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

Intervention Type DRUG

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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maha abou-zeid

Assistant Professor of Anesthesia and Surgical Intensive Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mansoura University-Emergency hospital-ICU

El Mansoura, Mansoura, Egypt

Site Status

Countries

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Egypt

Central Contacts

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Maha AboZeid, MD

Role: CONTACT

02-01019216192

Other Identifiers

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TAP-neostigmine

Identifier Type: -

Identifier Source: org_study_id

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