Gabapentin for Prophylaxis Intrathecal Morphine-Induced Pruritus

NCT01236859 | Completed DMC

• 1 other identifier: GP180
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Pruritus

Keywords

Gabapentin; prophylaxis; incidence of pruritus; intrathecal morphine

Outcome Measures

Primary Outcomes (1)

• incidence of pruritus postoperatively

  the incidence of pruritus during the 24 h follow-up period

  0-24 h

Secondary Outcomes (1)

• onset time and severity of pruritus

  0-24 h

Study Arms (2)

placebo

PLACEBO COMPARATOR

The patients in the placebo group received equal numbers of identical looking placebo 2 h before operation

Drug: Gabapentin

gabapentin

ACTIVE COMPARATOR

Patients in the gabapentin group received two capsules of gabapentin 300 mg (Neurontin®, Pfizer) at 2 h before operation.

Drug: Gabapentin

Interventions

Gabapentin DRUG

Neurontin®, Pfizer

Also known as: Neurontin®, Pfizer

gabapentin; placebo

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prince of Songkla University: lead

Study Sites (1)

Songklanagarind Hospital

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Pruritus

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Wirinda Chiravanich, MD

  Prince of Songkhla University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 8, 2010
• First Posted: November 9, 2010
• Study Start: September 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: November 1, 2010
• Last Updated: October 9, 2013

Record last verified: 2013-10

Locations

TH (1)