The Effect of Gabapentin on Thoracic Epidural Analgesia Following Thoracotomy

NCT01116583 | Completed Phase 3 DMC

• 1 other identifier: 2007-002769-11
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain, Postoperative

Keywords

Gabapentin; Thoracotomy; Pain, Postoperative; Analgesia; Recovery of Function; Quality of Life

Outcome Measures

Primary Outcomes (6)

• Persistent post surgical pain

  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.

  3 months after surgery

• Acute postoperative pain

  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.

  Within the first 5 postoperative days

• Usage of epidural infusion of local and opioid analgesics (ml)

  Within the first 5 postoperative days

• Persistent post surgical pain

  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 months following surgery

• Persistent post surgical pain

  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.

  12 months following surgery

• Early postoperative pain

  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.

  14 days (+/-3 days) following discharge

Secondary Outcomes (16)

• Consumption of opioid analgesics

  Within the first 5 postoperative days

• Time to first request for additional analgesics

  Within the first 5 postoperative days

• Analgesia related side-effects

  Within the first 5 postoperative days

• Convalescence of gastrointestinal function

  Within the first 5 postoperative days

• Health related quality of life

  Day 14 (+/-3 days) following discharge

Study Arms (2)

Gabapentin

ACTIVE COMPARATOR

Gabapentin group

Drug: Gabapentin

Placebo

PLACEBO COMPARATOR

Placebo group

Drug: Placebo

Interventions

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)

Also known as: Gabapentin "Sandoz" 300 mg

Gabapentin

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

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital Skejby: collaborator

Study Sites (1)

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

Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

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

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

• Hans K Pilegaard, MD, Chief Surgeon

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

  PRINCIPAL INVESTIGATOR

• Kasper Grosen, RN, MHScS, PhDS

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

  STUDY DIRECTOR

• Vibeke Hjortdal, MD, Professor, DMSc, PhD

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

  STUDY CHAIR

• Mogens P Jensen, MD, Chief Physician, PhD

  Department of Reumatology, Aarhus University Hospital, Aarhus Hospital, Denmark

  STUDY CHAIR

• Gerhard Linnemann, MD, Chief Physician

  Department of Anaesthesiology and Intensive Care, Aarhus University Hospital, Skejby, Denmark

  STUDY CHAIR

• Vibeke Laursen, RN

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

  STUDY CHAIR

• Anette Hoejsgaard, MD

  Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2010
• First Posted: May 5, 2010
• Study Start: May 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: August 5, 2014

Record last verified: 2012-09

Locations

DK (1)