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Duloxetine for Succinylcholine-induced Postoperative Myalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03037073
Recruitment Status : Completed
First Posted : January 31, 2017
Last Update Posted : November 12, 2019
Information provided by (Responsible Party):
MOHAMED F. MOSTAFA, Assiut University

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.

Condition or disease Intervention/treatment Phase
Postoperative Myalgia Drug: Duloxetine Drug: Placebo oral capsule Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Impact of Duloxetine on Succinylcholine-induced Postoperative Myalgia During Direct Microlaryngoscopic Surgeries: Randomized Controlled Double-blind Study
Actual Study Start Date : February 7, 2017
Actual Primary Completion Date : November 7, 2019
Actual Study Completion Date : November 7, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Group D
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
35 patients will receive duloxetine (Cymbalta; Eli Lilly & Company, Indiana, USA) 30 mg orally with sips of water, 2 h before induction of anesthesia.

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

Primary Outcome Measures :
  1. Four-point scale for myalgia [ Time Frame: 24 hours ]
    Myalgia is defined as "a pain with no surgical interference"

Secondary Outcome Measures :
  1. Four-point scale for fasciculations [ Time Frame: 5 minutes ]
    Score to assess the intensity of fasciculations

  2. Ramsay sedation score [ Time Frame: 24 hours ]
    To assess the postoperative sedation level

  3. Postoperative Complications [ Time Frame: 24 hours ]
    Percentage of patients with any complications will be recorded and treated

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03037073

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Assiut university hospital
Assiut, Egypt, 71515
Sponsors and Collaborators
Assiut University
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Study Chair: OSAMA A. IBRAHIM, MD Assiut University
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Responsible Party: MOHAMED F. MOSTAFA, Lecturer of Anesthesia and Intensive Care, Assiut University Identifier: NCT03037073    
Other Study ID Numbers: Duloxetine POM
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MOHAMED F. MOSTAFA, Assiut University:
Postoperative Myalgia
Additional relevant MeSH terms:
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Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Musculoskeletal Pain
Neurologic Manifestations
Signs and Symptoms
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents