The Effect of Gabapentin on Thoracic Epidural Analgesia Following Thoracotomy

Phase 3

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: Placebo; Drug: Gabapentin

• Registration Number: NCT01116583
• Lead Sponsor: University of Aarhus

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-27
• Study First Submitted QC: 2010-05-03
• Study First Posted: 2010-05-05
• Study Start: 2011-05
• Status Verified: 2012-09
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Last Update Submitted: 2014-08-04
• Last Update Posted: 2014-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo group
Gabapentin	Gabapentin	Gabapentin group

Primary Outcome Measures

Name	Time	Method
Acute postoperative pain	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.
Persistent post surgical pain	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.
Usage of epidural infusion of local and opioid analgesics (ml)	Within the first 5 postoperative days
Early postoperative pain	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 Outcome Measures

Name	Time	Method
Health related quality of life	12 months following surgery	Health related quality of life is measured with the EORCT QLQ-C30 and EORCT QLQ-LC13 questionnaires.
Patient satisfaction	Within the first 5 postoperative days	Patient satisfaction is assesed with the EORCT-INPATSAT32 questionnaire
Intensity of preoperative anxiety	2 hours after administration of the first dose of study medication	Anxiety is measured on a 11-point numeric rating scale (NRS).
Convalescence of lung function (spirometry)	Within the first five postoperative days	FVC, FEV-1 and PEF is measured.
Hospital length of stay (days)	At time of discharge
Convalescence of gastrointestinal function	Within the first 5 postoperative days	Convalescence of gastrointestinal function (time to first defecation)
Use of a vasopressor agent to correct hypotension	Within the first 5 days of surgery
Analgesia related side-effects	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
Sleep quality	Within the first five postoperative days	Sleep quality is measured on a 11-point numeric rating scale (NRS)
Walking distance (meters)	Postoperative day 3	Ability to walk is measured by means of the 6-minutes walking test on postoperative day 3.
Fatigue	Within the first 5 postoperative days	Fatigue is measured on a 4-point verbal rating scale (0=None, 1=Mild, 2=Moderate, 3=Severe).
Consumption of opioid analgesics	Within the first 5 postoperative days
Time to first request for additional analgesics	Within the first 5 postoperative days

Trial Locations

Locations (1)

Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby; 🇩🇰 Aarhus N, Denmark