Duloxetine for Succinylcholine-induced Postoperative Myalgia

NCT03037073 | Completed Phase 2 DMC

• 1 other identifier: Duloxetine POM
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

For \>60 years, succinylcholine is still being administered as a selective relaxant for rapid sequence intubation by anesthesiologists in many countries. It has been shown to possess unique features such as low cost, fast-acting, short half-life, safe metabolites, and causing excellent muscle relaxation for intubation. It has many side effects as well. Postoperative myalgia (POM), with an incidence rate of \~41%-92%, is one of the most common side effects of this drug and can take several days to cause significant discomfort in patients. However, its effect is felt more in the throat, neck, shoulder, and abdominal muscles and is common among patients with outpatient surgery. Due to its unknown real context of pathogenesis and in an effort to reduce the incidence and severity of succinylcholine-induced myalgia, various medications including nondepolarizing muscle relaxants, benzodiazepines, magnesium sulfate, opioids, gabapentin, and nonsteroidal anti-inflammatory drugs have been tested, with varying degrees of success. Duloxetine is an US Food and Drug Administration-approved analgesic used for various pain syndromes, including diabetic peripheral neuropathy and fibromyalgia. The underlying mechanism for duloxetine against these pain syndromes remains unclear, but it may involve three major central nervous system (CNS) targets: (1) serotonin transporter (Ki, 4.6 nM), (2) norepinephrine transporter (Ki, 16 nM), and (3) dopamine transporter (Ki, 370 nM). In the past, the antidepressant action was often thought to be the primary mechanism for its analgesic efficacy. This theory was addressed later by "Path Analysis," and the result showed that duloxetine affects pain directly rather than indirectly through mood improvement. In addition to these multiple CNS targets, duloxetine, like the antidepressant amitriptyline and the local anesthetic bupivacaine, blocks voltage-gated Na+ channels. Because neuronal Na+ channels are present in both CNS and peripheral nervous systems, such a finding expands the possible analgesic action and locus of duloxetine.

Conditions

Postoperative Myalgia

Keywords

Duloxetine; Succinylcholine; Postoperative Myalgia; Microlaryngoscopy

Outcome Measures

Primary Outcomes (1)

• Four-point scale for myalgia

  Myalgia is defined as "a pain with no surgical interference"

  24 hours

Secondary Outcomes (3)

• Four-point scale for fasciculations

  5 minutes

• Ramsay sedation score

  24 hours

• Postoperative Complications

  24 hours

Study Arms (2)

Group D

ACTIVE COMPARATOR

35 patients will receive duloxetine (Cymbalta; Eli Lilly \& Company, Indiana, USA) 30 mg orally with sips of water, 2 h before induction of anesthesia.

Drug: Duloxetine

Group C

ACTIVE COMPARATOR

35 patients will receive similar-looking placebo capsules (starch capsules) orally with sips of water, 2 h before induction of anesthesia.

Drug: Placebo oral capsule

Interventions

Duloxetine DRUG

35 patients will receive duloxetine (Cymbalta; Eli Lilly \& Company, Indiana, USA) 30 mg orally with sips of water, 2 h before induction of anesthesia.

Group D

Placebo oral capsule DRUG

35 patients will receive similar-looking placebo capsules (starch capsules) orally with sips of water, 2 h before induction of anesthesia.

Group C

Eligibility Criteria

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

You may qualify if:

• age 20-60 years
• either sex
• ASA physical status I or II

You may not qualify if:

• known allergy to duloxetine, abnormal renal and liver function tests, history of chronic pain
• regular medication with SNRI or analgesics (excluding acetaminophen and nonsteroidal anti-inflammatory drugs)
• patients with a history of seizure disorders
• hyperkalemia
• systemic illness like hypertension
• diabetes
• increased intracranial and intraocular pressure
• pregnant or breast-feeding females.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university hospital

Asyut, 71515, Egypt

Location

MeSH Terms

Interventions

Duloxetine Hydrochloride

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• OSAMA A. IBRAHIM, 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 26, 2017
• First Posted: January 31, 2017
• Study Start: April 15, 2017
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: October 19, 2020

Record last verified: 2020-10

Locations

EG (1)