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Completed

NCT Number: NCT01116583

The Effect of Gabapentin on Thoracic Epidural Analgesia Following Thoracotomy

The purpose of this trial is to investigate the effect of gabapentin on thoracic epidural analgesia following thoracotomy, including assessment of both analgesia, pain intensity, pain quality and whether or not gabapentin prevents the development of chronic pain conditions following thoracotomy.

The main hypothesis is that gabapentin reduces the proportion of patients who develop a persistent pain condition following thoracotomy from 50% to 20%.

Furthermore gabapentin is expected to reduce both pain intensity measured on a 11-point numerical rating scale, usage of epidural infusions of local and/or opioid analgesics, morbidity, hospital length of stay, consumption of opioid analgesics and analgesia-related side-effects.

In addition gabapentin is expected to improve postoperative recovery by means of postoperative lung function, walking ability, health related quality of life and patient satisfaction

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Key information

Conditions

Pain, Postoperative Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby

Aarhus N, 8200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elective lung resection via thoracotomy
  • Age > 18 and < 80 years

Exclusion criteria

  • Inability to answer the detailed questionnaires on pain and quality of life
  • Psychiatric disease (ICD-10)
  • Severe renal impairment (se-creatinin > 110 mmol/l)
  • Known allergy to gabapentin, morphine, bupivacaine and / or ibuprofen
  • Standard use of opioid analgesics
  • Treatment with anticonvulsants or tricyclic antidepressants
  • Use of antacids 24 hours before the intake of study medication
  • Contraindicated placement of a thoracic epidural catheter
  • Previous ipsilateral thoracotomy
  • Presence of a chronic pain syndrome
  • Acute pancreatitis
  • A history of past or current alcohol and / or illegal substance abuse.
  • A history of gastric or duodenal ulcer
  • Gastrointestinal obstruction
  • Pregnancy
  • Participation in another intervention study

Treatment and study plan

Gabapentin

Drug

Preoperatively (2 hours before surgery): 4 gabapentin capsules each containing 300 mg gabapentin (total gabapentin dose 1200 mg)

Postoperative day 1: gabapentin 300 mg x 2 (total gabapentin dose 600 mg)

Postoperative day 2: gabapentin 300 mg x 3 (total gabapentin dose 900 mg)

Postoperative day 3: gabapentin 300 mg x 4 (total gabapentin dose 1200 mg)

Postoperative day 4: gabapentin 300 mg x 4 (total gabapentin dose 1200 mg)

Postoperative day 5: gabapentin 300 mg x 4 (total gabapentin dose 1200 mg)

Other names: Gabapentin "Sandoz" 300 mg

Placebo

Drug

Preoperatively (2 hours before surgery): 4 placebo capsules

Postoperative day 1: 1 placebo capsule x 2

Postoperative day 2: 1 placebo capsule x 3

Postoperative day 3: 1 placebo capsule x 4

Postoperative day 4: 1 placebo capsule x 4

Postoperative day 5: 1 placebo capsule x 4

Primary outcomes

  1. Persistent post surgical pain

    Time frame: 3 months after surgery

    Pain is assessed by means of the Brief Pain Inventory (BPI-SF) and The McGill Pain Questionnaire (SF-MPQ). Persistent postoperative pain is measured both on a 11-point numeric pain rating scale and on a 10 cm visual analog scale (VAS). A score >=3 is considered as moderate pain.

  2. Acute postoperative pain

    Time frame: Within the first 5 postoperative days

    Acute postoperative pain is measured on a 11-point numeric rating scale both at rest and when coughing/sitting up. General pain intensity and specific (shoulder) pain intensity are measured. On postoperative day 4 pain is furthermore assessed by means of the Brief Pain Inventory (BPI-SF) and The McGill Pain Questionnaire (SF-MPQ). A score >=3 is considered as moderate pain.

  3. Usage of epidural infusion of local and opioid analgesics (ml)

    Time frame: Within the first 5 postoperative days

  4. Persistent post surgical pain

    Time frame: 6 months following surgery

    Pain is assessed by means of the Brief Pain Inventory (BPI-SF) and The McGill Pain Questionnaire (SF-MPQ). Persistent postoperative pain is measured both on a 11-point numeric pain rating scale and on a 10 cm visual analog scale (VAS). A score >=3 is considered as moderate pain.

  5. Persistent post surgical pain

    Time frame: 12 months following surgery

    Pain is assessed by means of the Brief Pain Inventory (BPI-SF) and The McGill Pain Questionnaire (SF-MPQ). Persistent postoperative pain is measured both on a 11-point numeric pain rating scale and on a 10 cm visual analog scale (VAS). A score >=3 is considered as moderate pain.

  6. Early postoperative pain

    Time frame: 14 days (+/-3 days) following discharge

    Early postoperative pain is measured on day 14 (+/-3 days) following discharge pain using the Brief Pain Inventory (BPI-SF) and The McGill Pain Questionnaire (SF-MPQ). A score >=3 is considered as moderate pain.

Secondary outcomes

  1. Consumption of opioid analgesics

    Time frame: Within the first 5 postoperative days

  2. Time to first request for additional analgesics

    Time frame: Within the first 5 postoperative days

  3. Analgesia related side-effects

    Time frame: Within the first 5 postoperative days

    Evaluation of the presence and/or severity of confusion, hallucinations, nausea, vomiting, usage of antiemetic drugs, urinary retention, sedation, pruitus, headache, respiratory depression, motor blockade and dizziness

  4. Convalescence of gastrointestinal function

    Time frame: Within the first 5 postoperative days

    Convalescence of gastrointestinal function (time to first defecation)

  5. Health related quality of life

    Time frame: Day 14 (+/-3 days) following discharge

    Health related quality of life is measured with the EORCT QLQ-C30 and EORCT QLQ-LC13 questionnaires.

  6. Patient satisfaction

    Time frame: Within the first 5 postoperative days

    Patient satisfaction is assesed with the EORCT-INPATSAT32 questionnaire

  7. Intensity of preoperative anxiety

    Time frame: 2 hours after administration of the first dose of study medication

    Anxiety is measured on a 11-point numeric rating scale (NRS).

  8. Convalescence of lung function (spirometry)

    Time frame: Within the first five postoperative days

    FVC, FEV-1 and PEF is measured.

  9. Sleep quality

    Time frame: Within the first five postoperative days

    Sleep quality is measured on a 11-point numeric rating scale (NRS)

  10. Walking distance (meters)

    Time frame: Postoperative day 3

    Ability to walk is measured by means of the 6-minutes walking test on postoperative day 3.

  11. Fatigue

    Time frame: Within the first 5 postoperative days

    Fatigue is measured on a 4-point verbal rating scale (0=None, 1=Mild, 2=Moderate, 3=Severe).

  12. Hospital length of stay (days)

    Time frame: At time of discharge

  13. Health related quality of life

    Time frame: 3 months following surgery

    Health related quality of life is measured with the EORCT QLQ-C30 and EORCT QLQ-LC13 questionnaires.

  14. Health related quality of life

    Time frame: 6 months following surgery

    Health related quality of life is measured with the EORCT QLQ-C30 and EORCT QLQ-LC13 questionnaires.

  15. Health related quality of life

    Time frame: 12 months following surgery

    Health related quality of life is measured with the EORCT QLQ-C30 and EORCT QLQ-LC13 questionnaires.

  16. Use of a vasopressor agent to correct hypotension

    Time frame: Within the first 5 days of surgery

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital Skejby

Registry information

Official study title

The Effect of Gabapentin on Thoracic Epidural Analgesia Following Thoracotomy - A Randomized, Double-blind, Placebo-controlled Trial

Acronym: GABATEA

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 5, 2010
Registry last updated
Aug 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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