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

• Sponsor: Mansoura University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05785377
• Collaborator: (none)
• Enrollment: 58
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 15
• Patients Per Site Per Month: 3.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Analgesia	Drug: Bupivacaine-Neostigmine; Drug: Bupivacaine	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 58 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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 blockaccording 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 (Participant, Investigator)
• Masking Description: The injectate used for TAPB will be prepared according to the group by an anesthesiologist who won't be involved in the data collection
• Primary Purpose: Prevention
• Official Title: Efficacy of Neostigmine as an Adjuvant to Bupivacaine in Ultrasound-guided Transversus Abdominis Plane Block as a Postoperative Analgesia After Caesarean Delivery.
• Anticipated Study Start Date: Dec 1, 2023
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 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	Drug: Bupivacaine; 20 mL bupivacaine 0.25% plus 1 mL normal saline 0.9%
Active Comparator: 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	Drug: Bupivacaine-Neostigmine; 20 mL bupivacaine 0.25% plus 1 mL Neostigmine (500 mcg)

Outcome Measures

Primary Outcome Measures

1. The time of the first postoperative analgesic requirement [during the first 24 postoperative hours]

   during the first 24 postoperative hours

Secondary Outcome Measures

1. Total amount of the postoperative analgesic drugs (ketolac, paracetamol and fentanyl) consumed in the [during the first 24 postoperative hours]

   mg

2. 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

3. 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

4. Mean arterial blood pressure (MBP) [basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours]

   mmHg

5. heart rate (HR) [basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours]

   beat per minute

6. Patient satisfaction about the quality of postoperative analgesia [during the first 24 postoperative hours]

   poor = 1, fair = 2, good = 3, excellent = 4

7. The side effects (nausea, vomiting, abdominal colic and lower limb weakness) [during the first 24 postoperative hours]

   incidence

8. the time from intrathecal injection till regression of spinal anesthesia to L2 dermatome [during the first 24 postoperative hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura University-Emergency hospital-ICU	El Mansoura	Mansoura	Egypt	35511

Sponsors and Collaborators

• Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: maha abou-zeid, Assistant Professor of Anesthesia and Surgical Intensive Care, Mansoura University
• ClinicalTrials.gov Identifier: NCT05785377
• Other Study ID Numbers: TAP-neostigmine
• First Posted: Mar 27, 2023
• Last Update Posted: Mar 27, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Bupivacaine; Neostigmine

Study Results

No Results Posted as of Mar 27, 2023