Neostigmine Versus Dexamethasone as Adjuvants to Lidocaine During Intravenous Local Anesthesia

NCT03021772 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-01-23

No results posted yet for this study

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

Interventions

DRUG

Neostigmine

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

DRUG

Dexamethasone

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

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • HAMDY A. YOUSSEF, MD · Assiut University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2018-09-30
Completion
2018-09-30

Countries

  • Egypt

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03021772 on ClinicalTrials.gov