Gabapentin for Prophylaxis Intrathecal Morphine-Induced Pruritus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
maliwan oofuvong, Prince of Songkla University
ClinicalTrials.gov Identifier:
NCT01236859
First received: November 8, 2010
Last updated: October 8, 2013
Last verified: October 2013
  Purpose

Intrathecal morphine provides good postoperative analgesia for up to 18-24 hour after administration. Pruritus is the most common side effect of intrathecal morphine, which the incidence was reported as 20%-100%2 and 63% in Songklanagarind Hospital. Pathophysiology of opioid-induced pruritus remain unclear and more than one mechanism may be involved in the development of opioid-induced pruritus, such as, mediated central µ opioid receptors, Dopamine (D2) receptors, Serotonin (5-HT3) receptors, prostaglandin system, GABA receptors, and glycine receptors, so that why opioid-induced pruritus is difficult to manage. Many medications have been used to treat this side effect included antihistamines, 5-HT3 (serotonin) receptor antagonists, opioid antagonists, opioid agonist-antagonists, propofol, and nonsteroidal antiinflammatory drugs.

Gabapentin is an anticonvulsant, a structural analog of aminobutyric acid, and currently approved by the Food and Drug Administration for the treatment of partial seizures and postherpetic neuralgia. Many studies have shown gabapentin to be effective in the case of brachioradial pruritus, itch of neuropathic in origin, uremic pruritus, multiple sclerosis-induced pruritus,cholestatic pruritus, itch produced by burn, and pruritus of unknown origin. However, there is only one small study in Taiwan shown the effectiveness of gabapentin 1200 mg in prevention of intrathecal morphine-induced pruritus in orthopedic surgery, which could reduce incidence of pruritus from 77.5% to 47.5% (38.7% reduction). Because gabapentin has several side effects especially in high dose such as drowsiness, dry mouth, headache, unsteadiness, reduced co-ordination or slowed reaction, constipation, diarrhea, peripheral edema, dizziness, confusion, loss of concentration, weight gain, and nausea, vomiting, so in our study we decided to reduce the dose of gabapentin. Therefore, we would like to know if gabapentin in a smaller dose (600 mg) used in the wider range of age including the elderly can decrease the incidence of intrathecal morphine-induced pruritus in orthopedic surgery in Songklanagarind Hospital.


Condition Intervention
Pruritus
Drug: Gabapentin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Gabapentin for Prophylaxis Intrathecal Morphine-Induced Pruritus After Orthopedics Surgery

Resource links provided by NLM:


Further study details as provided by Prince of Songkla University:

Primary Outcome Measures:
  • incidence of pruritus postoperatively [ Time Frame: 0-24 h ] [ Designated as safety issue: Yes ]
    the incidence of pruritus during the 24 h follow-up period


Secondary Outcome Measures:
  • onset time and severity of pruritus [ Time Frame: 0-24 h ] [ Designated as safety issue: Yes ]
    The difference of onset time and severity of pruritus in the gabapentin and placebo groups


Enrollment: 180
Study Start Date: September 2009
Study Completion Date: November 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
The patients in the placebo group received equal numbers of identical looking placebo 2 h before operation
Drug: Gabapentin
Neurontin®, Pfizer
Other Name: Neurontin®, Pfizer
Active Comparator: gabapentin
Patients in the gabapentin group received two capsules of gabapentin 300 mg (Neurontin®, Pfizer) at 2 h before operation.
Drug: Gabapentin
Neurontin®, Pfizer
Other Name: Neurontin®, Pfizer

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • aged between 15-70 yr, ASA physical status I-III, and were scheduled for lower limb surgery under spinal anesthesia.

Exclusion Criteria:

  • contraindication for spinal anesthesia, known allergy history to gabapentin, complaint of pruritus before surgery, morbid obesity (BMI > 35), coexisting skin disorder, and any systemic disease associated with pruritus. Patients who had history of seizure attacks, mental illness, chronic headache, or neuropathic pain and were concomitantly using of anticonvulsants, antidepressants, antipsychotics, or antihistamine
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01236859

Locations
Thailand
Songklanagarind Hospital
Hat Yai, Songkhla, Thailand, 90110
Sponsors and Collaborators
Prince of Songkla University
Investigators
Principal Investigator: Wirinda Chiravanich, MD Prince of Songkhla University
  More Information

No publications provided

Responsible Party: maliwan oofuvong, Assistant Professor, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT01236859     History of Changes
Other Study ID Numbers: GP180
Study First Received: November 8, 2010
Last Updated: October 8, 2013
Health Authority: Thailand: Ethical Committee

Keywords provided by Prince of Songkla University:
Gabapentin
prophylaxis
incidence of pruritus
intrathecal morphine

Additional relevant MeSH terms:
Pruritus
Skin Diseases
Skin Manifestations
Signs and Symptoms
Morphine
Gabapentin
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents

ClinicalTrials.gov processed this record on July 29, 2014