Analgesic Effect of Gabapentin in Total Knee Arthroplasty (TKA)

• Sponsor: Hvidovre University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01507363
• Collaborator: Lundbeck Foundation (Other)
• Enrollment: 300
• Locations: 3
• Arms: 3
• Duration (Months): 22
• Patients Per Site: 100
• Patients Per Site Per Month: 4.5

Study Details

Study Description

Brief Summary

Pain is a major problem after TKA. Gabapentin may reduce acute postoperative pain. The investigators therefore investigate the effect of Gabapentin as a perioperative analgesic.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain; Postoperative Sedation	Drug: Gabapentin; Drug: Gabapentin; Drug: Placebo	Phase 4

Detailed Description

Pain is a major problem after TKA. Studies indicate that Gabapentin may reduce acute postoperative pain. However, the optimal dose is unknown and there is constant controversy on analgesic versus side-effects. The investigators therefore investigate the effect of Gabapentin as a perioperative analgesic in a dose-related manner and with a sample-size allowing evaluation of side-effects.

Study Design

• Study Type: Interventional
• Actual Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Analgesic Effect of Perioperative Gabapentin in Total Knee Arthroplasty: A Randomized, Double-blind, Placebo-controlled, Dose-response Study
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Nov 1, 2013
• Actual Study Completion Date: Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Gabapentin "high" Tables with Gabapentin (1300 mg/day) for 7 days, starting on the day of surgery	Drug: Gabapentin; Tables with Gabapentin (1300 mg/ day) for 7 days, starting on the day of surgery
Active Comparator: Gabapentin "intermediate" Tables with Gabapentin for 7 days (900 mg/day), starting on the day of surgery	Drug: Gabapentin; Tables with Gabapentin (900 mg/day) for 7 days, starting on the day of surgery
Placebo Comparator: Placebo Placebo tablets for 7 days, starting on the day of surgery	Drug: Placebo; Placebo tablets for 7 days, starting on the day of surgery

Outcome Measures

Primary Outcome Measures

1. Pain [At 24 hour]

   Pain during walking at 24 hour after surgery, visuel analog scale (VAS, 0-100 mm)

Secondary Outcome Measures

1. Sedation [At 6 hours]

   Sedation at 6 hours, numeric range scale (NRS, 0-10)

2. Pain [1 week]

   Pain at rest and during walking the first week after TKA, visuel analog scale (VAS, 0-100 mm)

3. Cumulated pain scores [1 week]

   Cumulated pain scores for pain the first week after TKA

4. Amount of rescue analgesic [1 week]

   Amount of rescue analgesic the first week after TKA, mg

5. Side effects [1 week]

   Side effects the first week after TKA

6. Cumulated side effects scores [1 week]

   Cumulated side effects scores the first week after TKA

7. Amount of ondansetron and sleeping medicine [1 week]

   Amount of ondansetron and sleeping medicine the first week after TKA, mg

8. Anxiety and depression [1 week]

   Anxiety and depression - questionnaire - the first week after TKA, Hospitality and Anxiety and Depression Scale

9. Gabapentin level in blood-sample [1 Day]

   Gabapentin level in blood-sample at 12 am on the first day after surgery, serum-koncentration

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Primary, unilateral total knee arthroplasty (TKA)

• Age 50-85 years

• Ethnic Danes

Exclusion Criteria:

• Treatment with gabapentins, systemic glucocorticoids, opioids, anxiolytic agents, antiepileptics or antidepressive agents (last 4 weeks)

• History of depression or mania

• History of alcohol or drug abuse

• History of malignancy

• History of epilepsia

• BMI > 40

• Disease affecting central or peripheral nerve function

• History of dementia

• History of renal insufficiency

• Allergy to Gabapentin

• Women with menstruation (last 2 years)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dep. of anesthesiology and ortopedic surgery Hvidovre Hospital	Copenhagen	Hvidovre	Denmark
2	Dep. of ortopedic surgery, Aalborg Sygehus	Aalborg		Denmark	9000
3	Dep. of ortopedic surgery, Esbjerg Sygehus	Esbjerg		Denmark	6700

Sponsors and Collaborators

• Hvidovre University Hospital
• Lundbeck Foundation

Investigators

• Principal Investigator: Torben B Hansen B Hansen, MD, Regionshospitalet Holstebro
• Study Director: Henrik Kehlet, MD, Rigshospitalet, Denmark
• Principal Investigator: Jørgen B Dahl, MD, Rigshospitalet, Denmark
• Principal Investigator: Per W Kristensen, MD, Vejle Sygehus
• Principal Investigator: Henrik Husted, MD, Hvidovre University Hospital
• Principal Investigator: Søren Solgaard, MD, Gentofte Hospital
• Principal Investigator: Mogens B Laursen, MD, Phd., Aalborg Sygehus
• Principal Investigator: Lars Hansen, MD, Esbjerg Sygehus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Troels Haxholdt Lunn, MD, principal and koordinating investigator, Hvidovre University Hospital
• ClinicalTrials.gov Identifier: NCT01507363
• Other Study ID Numbers: THL-06-11; 2011-003105-22; H-4-2011-082
• First Posted: Jan 10, 2012
• Last Update Posted: Apr 11, 2014
• Last Verified: Apr 1, 2014

• Additional relevant MeSH terms: Pain, Postoperative; Gabapentin

Study Results

No Results Posted as of Apr 11, 2014