Neostigmine Versus Dexamethasone as Adjuvants to Lidocaine During Intravenous Local Anesthesia

NCT03021772 | Completed Phase 2 DMC

• 1 other identifier: Bier Block
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Intravenous regional anesthesia (IVRA) is described firstly in 1908 by August Bier. It is simple, safe, reliable, less cost, efficient method in forearm surgery. The advantage of this method has fast return of motor and sensory function which enables patients for earlier discharge. However, this method has disadvantages such as tourniquet pain, insufficient muscle relaxation and postoperative analgesia. Lidocaine inhibits action potential propagation within neuronal tissue by binding to receptors in Na+ channels located on the nerve cell membrane. Lidocaine IVRA is safe and effective and is associated with a rapid onset (4.5 minutes) of anesthesia after injection and termination of analgesia (5.8 ± 0.5 minutes) once the tourniquet is deflated. Neostigmine is a typical cholinesterase inhibitor. It increases the level of acetylcholine (Ach) and indirectly stimulates both nicotinic and muscarinic receptors. In anesthesia, neostigmine is a drug that has been used for reversal of residual neuromuscular block. Administration of neostigmine by intrathecal and epidural routes has been found to cause analgesia by inhibition of the breakdown of Ach in the spinal cord. Dexamethasone is commonly used in anesthesia to prevent postoperative nausea and vomiting (PONV). Two recent meta-analyses have documented that dexamethasone also reduced postoperative pain and opioid requirement. Intravenous dexamethasone has also been shown to improve postoperative pain control in patients receiving spinal or epidural morphine. Hong et al reported that intravenous dexamethasone in combination with a caudal block with ropivacaine prolonged the duration of postoperative analgesia without adverse effects in children undergoing orchidopexy. So the investigators expect that addition of dexamethasone or neostigmine will affect duration and postoperative analgesia in bier block.

Conditions

Adjuvants, Anesthesia

Keywords

Neostigmine; Dexamethasone; Intravenous Local Anesthesia

Outcome Measures

Primary Outcomes (1)

• Pain assessed on VAS

  perfalgan will be given when visual analogue score ≥ 4

  24 hours

Secondary Outcomes (3)

• Sensory level

  2 hours

• Motor level

  2 hours

• Number of patients with any complications

  24 hours

Study Arms (2)

Group N

ACTIVE COMPARATOR

30 patients will receive intravenous 3mg/kg lidocaine 2 % (diluted with normal saline to 40 ml) + 0.5 mg neostigmine for Bier block.

Drug: Neostigmine

Group D

ACTIVE COMPARATOR

30 patients will receive intravenous 3mg/kg lidocaine 2 % (diluted with normal saline to 40 ml) + 8 mg dexamethasone for Bier block.

Drug: Dexamethasone

Interventions

Neostigmine DRUG

Patients will receive intravenous 3mg/kg lidocaine 2 % (diluted with normal saline to 40 ml) + 0.5 mg neostigmine for Bier block.

Group N

Dexamethasone DRUG

Patients will receive intravenous 3mg/kg lidocaine 2 % (diluted with normal saline to 40 ml) + 8 mg dexamethasone for Bier block.

Group D

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age from 20 - 60 years.
• ASA grade I - II.
• Surgical time does not exceed 90 minutes.

You may not qualify if:

• Patient refusal.
• Any contraindication of regional anesthesia block (e.g. Coagulopathy, infection at the needle insertion site or vascular insufficiency).
• A personal history of seizures, peripheral neurologic diseases, cardiac arrhythmias, sickle cell anemia, liver dis¬ease, renal dysfunction and cardiac conduction abnormalities.
• Patients with allergy to amide local anesthetics or medication included in the study.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university hospital

Asyut, 71515, Egypt

Location

MeSH Terms

Interventions

Neostigmine; Dexamethasone

Intervention Hierarchy (Ancestors)

Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• HAMDY A. YOUSSEF, MD

  Assiut University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia and Intensive Care

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 16, 2017
• Study Start: January 1, 2017
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: January 23, 2019

Record last verified: 2019-01

Locations

EG (1)