The Effect of Gabapentin on Thoracic Epidural Analgesia Following Thoracotomy

Pain, Postoperative Clinical Trial

— GABATEA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01116583
• Other study ID #: 2007-002769-11
• Status: Completed
• Phase: Phase 3
• First received: April 27, 2010
• Last updated: August 4, 2014
• Start date: May 2011
• Est. completion date: November 2013

Study information

• Verified date: September 2012
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: The Regional Committee on Biomedical Research EthicsDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Gabapentin
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)
• Placebo
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

Locations

Country	Name	City	State
Denmark	Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby	Aarhus N

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital Skejby

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	Usage of epidural infusion of local and opioid analgesics (ml)		Within the first 5 postoperative days	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Consumption of opioid analgesics		Within the first 5 postoperative days	No
Secondary	Time to first request for additional analgesics		Within the first 5 postoperative days	No
Secondary	Analgesia related side-effects	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	Within the first 5 postoperative days	No
Secondary	Convalescence of gastrointestinal function	Convalescence of gastrointestinal function (time to first defecation)	Within the first 5 postoperative days	No
Secondary	Health related quality of life	Health related quality of life is measured with the EORCT QLQ-C30 and EORCT QLQ-LC13 questionnaires.	Day 14 (+/-3 days) following discharge	No
Secondary	Patient satisfaction	Patient satisfaction is assesed with the EORCT-INPATSAT32 questionnaire	Within the first 5 postoperative days	No
Secondary	Intensity of preoperative anxiety	Anxiety is measured on a 11-point numeric rating scale (NRS).	2 hours after administration of the first dose of study medication	No
Secondary	Convalescence of lung function (spirometry)	FVC, FEV-1 and PEF is measured.	Within the first five postoperative days	No
Secondary	Sleep quality	Sleep quality is measured on a 11-point numeric rating scale (NRS)	Within the first five postoperative days	No
Secondary	Walking distance (meters)	Ability to walk is measured by means of the 6-minutes walking test on postoperative day 3.	Postoperative day 3	No
Secondary	Fatigue	Fatigue is measured on a 4-point verbal rating scale (0=None, 1=Mild, 2=Moderate, 3=Severe).	Within the first 5 postoperative days	No
Secondary	Hospital length of stay (days)		At time of discharge	No
Secondary	Health related quality of life	Health related quality of life is measured with the EORCT QLQ-C30 and EORCT QLQ-LC13 questionnaires.	3 months following surgery	No
Secondary	Health related quality of life	Health related quality of life is measured with the EORCT QLQ-C30 and EORCT QLQ-LC13 questionnaires.	6 months following surgery	No
Secondary	Health related quality of life	Health related quality of life is measured with the EORCT QLQ-C30 and EORCT QLQ-LC13 questionnaires.	12 months following surgery	No
Secondary	Use of a vasopressor agent to correct hypotension		Within the first 5 days of surgery	No