Clinical trial NCT01116583: The Effect of Gabapentin on Thoracic Epidural Analgesia Following Thoracotomy
Official title: The Effect of Gabapentin on Thoracic Epidural Analgesia Following Thoracotomy - A Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain, Postoperative
Keywords: Gabapentin
Thoracotomy
Pain, Postoperative
Analgesia
Recovery of Function
Quality of Life
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital Skejby
First posted: 2010-05-05
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: Persistent post surgical pain
timeFrame: 3 months after surgery
measure: Acute postoperative pain
timeFrame: Within the first 5 postoperative days
measure: Usage of epidural infusion of local and opioid analgesics (ml)
timeFrame: Within the first 5 postoperative days
measure: Persistent post surgical pain
timeFrame: 6 months following surgery
measure: Persistent post surgical pain
timeFrame: 12 months following surgery
measure: Early postoperative pain
timeFrame: 14 days (+/-3 days) following discharge
Secondary outcomes:
measure: Consumption of opioid analgesics
timeFrame: Within the first 5 postoperative days
measure: Time to first request for additional analgesics
timeFrame: Within the first 5 postoperative days
measure: Analgesia related side-effects
timeFrame: Within the first 5 postoperative days
measure: Convalescence of gastrointestinal function
timeFrame: Within the first 5 postoperative days
measure: Health related quality of life
timeFrame: Day 14 (+/-3 days) following discharge
measure: Patient satisfaction
timeFrame: Within the first 5 postoperative days
measure: Intensity of preoperative anxiety
timeFrame: 2 hours after administration of the first dose of study medication
measure: Convalescence of lung function (spirometry)
timeFrame: Within the first five postoperative days
measure: Sleep quality
timeFrame: Within the first five postoperative days
measure: Walking distance (meters)
timeFrame: Postoperative day 3
measure: Fatigue
timeFrame: Within the first 5 postoperative days
measure: Hospital length of stay (days)
timeFrame: At time of discharge
measure: Health related quality of life
timeFrame: 3 months following surgery
measure: Health related quality of life
timeFrame: 6 months following surgery
measure: Health related quality of life
timeFrame: 12 months following surgery
measure: Use of a vasopressor agent to correct hypotension
timeFrame: Within the first 5 days of surgery
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby
Study officials:
affiliation: Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby, Denmark
name: Hans K Pilegaard, MD, Chief Surgeon
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby, Denmark
name: Kasper Grosen, RN, MHScS, PhDS
role: STUDY_DIRECTOR
affiliation: Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby, Denmark
name: Vibeke Hjortdal, MD, Professor, DMSc, PhD
role: STUDY_CHAIR
affiliation: Department of Reumatology, Aarhus University Hospital, Aarhus Hospital, Denmark
name: Mogens P Jensen, MD, Chief Physician, PhD
role: STUDY_CHAIR
affiliation: Department of Anaesthesiology and Intensive Care, Aarhus University Hospital, Skejby, Denmark
name: Gerhard Linnemann, MD, Chief Physician
role: STUDY_CHAIR
affiliation: Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby, Denmark
name: Vibeke Laursen, RN
role: STUDY_CHAIR
affiliation: Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital
name: Anette Hoejsgaard, MD
role: STUDY_CHAIR
References: