Gabapentin for Prophylaxis Intrathecal Morphine-Induced Pruritus

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: NCT01236859
Recruitment Status : Completed
First Posted : November 9, 2010
Last Update Posted : October 9, 2013
Information provided by (Responsible Party):
maliwan oofuvong, Prince of Songkla University

Brief Summary:

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 or disease Intervention/treatment Phase
Pruritus Drug: Gabapentin Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Gabapentin for Prophylaxis Intrathecal Morphine-Induced Pruritus After Orthopedics Surgery
Study Start Date : September 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. incidence of pruritus postoperatively [ Time Frame: 0-24 h ]
    the incidence of pruritus during the 24 h follow-up period

Secondary Outcome Measures :
  1. onset time and severity of pruritus [ Time Frame: 0-24 h ]
    The difference of onset time and severity of pruritus in the gabapentin and placebo groups

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.

Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT01236859

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

Responsible Party: maliwan oofuvong, Assistant Professor, Prince of Songkla University Identifier: NCT01236859     History of Changes
Other Study ID Numbers: GP180
First Posted: November 9, 2010    Key Record Dates
Last Update Posted: October 9, 2013
Last Verified: October 2013

Keywords provided by maliwan oofuvong, Prince of Songkla University:
incidence of pruritus
intrathecal morphine

Additional relevant MeSH terms:
Skin Diseases
Skin Manifestations
Signs and Symptoms
gamma-Aminobutyric Acid
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents