Pain, PostoperativePhase 3GABATEANCT01116583

The Effect of Gabapentin on Thoracic Epidural Analgesia Following Thoracotomy

A Phase 3 study testing Gabapentin in people with Pain, Postoperative, run by University of Aarhus at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Pain, Postoperative
What is being tested?: Gabapentin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 104 participants
Where: 1 siteDenmark
Study dates: May 2011to Nov 2013
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 16Show fewer

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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby
Aarhus N, 8200

Other trials in Denmark

About this study

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

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
Being tested: Gabapentin, Placebo
Keywords: Gabapentin, Thoracotomy, Pain, Postoperative, Analgesia, Recovery of Function, Quality of Life
Medical subject headings: Pain, Postoperative, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GabapentinDrug
Also called Gabapentin "Sandoz" 300 mg
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)
PlaceboDrug
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

Study groups in NCT01116583
Study group	Role	What they receive
Gabapentin	Active comparator	Gabapentin group Receives: Drug: Gabapentin
Placebo	Placebo comparator	Placebo group Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Within the first 5 postoperative days
Usage of epidural infusion of local and opioid analgesics (ml)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 14 days (+/-3 days) following discharge

Secondary outcomes (16)

Consumption of opioid analgesics
Measured: Within the first 5 postoperative days
Time to first request for additional analgesics
Measured: Within the first 5 postoperative days
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
Measured: Within the first 5 postoperative days
Convalescence of gastrointestinal function
Convalescence of gastrointestinal function (time to first defecation)
Measured: Within the first 5 postoperative days
Health related quality of life
Health related quality of life is measured with the EORCT QLQ-C30 and EORCT QLQ-LC13 questionnaires.
Measured: Day 14 (+/-3 days) following discharge
Patient satisfaction
Patient satisfaction is assesed with the EORCT-INPATSAT32 questionnaire
Measured: Within the first 5 postoperative days
Intensity of preoperative anxiety
Anxiety is measured on a 11-point numeric rating scale (NRS).
Measured: 2 hours after administration of the first dose of study medication
Convalescence of lung function (spirometry)
FVC, FEV-1 and PEF is measured.
Measured: Within the first five postoperative days
Sleep quality
Sleep quality is measured on a 11-point numeric rating scale (NRS)
Measured: Within the first five postoperative days
Walking distance (meters)
Ability to walk is measured by means of the 6-minutes walking test on postoperative day 3.
Measured: Postoperative day 3
Fatigue
Fatigue is measured on a 4-point verbal rating scale (0=None, 1=Mild, 2=Moderate, 3=Severe).
Measured: Within the first 5 postoperative days
Hospital length of stay (days)
Measured: At time of discharge
Health related quality of life
Health related quality of life is measured with the EORCT QLQ-C30 and EORCT QLQ-LC13 questionnaires.
Measured: 3 months following surgery
Health related quality of life
Health related quality of life is measured with the EORCT QLQ-C30 and EORCT QLQ-LC13 questionnaires.
Measured: 6 months following surgery
Health related quality of life
Health related quality of life is measured with the EORCT QLQ-C30 and EORCT QLQ-LC13 questionnaires.
Measured: 12 months following surgery
Use of a vasopressor agent to correct hypotension
Measured: Within the first 5 days of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2011Nov 2013

First posted5 May 2010 (estimated)
Study startMay 2011
Primary completionNov 2013
Study completionNov 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
More trials run by University of AarhusThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 104 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01116583
Sponsor's protocol ID: 2007-002769-11
Acronym: GABATEA
Status last verified: Sep 2012
First submitted: 27 Apr 2010
Last updated: 5 Aug 2014
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Gabapentin on Thoracic Epidural Analgesia Following Thoracotomy - A Randomized, Double-blind, Placebo-controlled Trial
ClinicalTrials.gov ID: NCT01116583
Acronym / sponsor ID: GABATEA / 2007-002769-11
Conditions: Pain, Postoperative
Keywords: Gabapentin, Thoracotomy, Pain, Postoperative, Analgesia, Recovery of Function, Quality of Life
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 104 participants (actual)
Lead sponsor: University of AarhusUniversity, hospital or other
Collaborators: Aarhus University Hospital Skejby
Study start: May 2011
Primary completion: Nov 2013 (actual)
Study completion: Nov 2013 (actual)
First posted: 5 May 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Gabapentin	Active comparator	Drug: GabapentinGabapentin group
Placebo	Placebo comparator	Drug: PlaceboPlacebo group

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (16 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GabapentinAlso: Gabapentin "Sandoz" 300 mgPreoperatively (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)	Drug	Gabapentin
PlaceboPreoperatively (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	Drug	Placebo

Primary outcome

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.
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.
Usage of epidural infusion of local and opioid analgesics (ml)
Time frame: Within the first 5 postoperative days
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.
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.
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.

16 secondary outcomes

Consumption of opioid analgesics
Time frame: Within the first 5 postoperative days
Time to first request for additional analgesics
Time frame: Within the first 5 postoperative days
Analgesia related side-effects
Time frame: Within the first 5 postoperative days
Convalescence of gastrointestinal function
Time frame: Within the first 5 postoperative days
Health related quality of life
Time frame: Day 14 (+/-3 days) following discharge
Patient satisfaction
Time frame: Within the first 5 postoperative days
Intensity of preoperative anxiety
Time frame: 2 hours after administration of the first dose of study medication
Convalescence of lung function (spirometry)
Time frame: Within the first five postoperative days
Sleep quality
Time frame: Within the first five postoperative days
Walking distance (meters)
Time frame: Postoperative day 3
Fatigue
Time frame: Within the first 5 postoperative days
Hospital length of stay (days)
Time frame: At time of discharge
Health related quality of life
Time frame: 3 months following surgery
Health related quality of life
Time frame: 6 months following surgery
Health related quality of life
Time frame: 12 months following surgery
Use of a vasopressor agent to correct hypotension
Time frame: Within the first 5 days of surgery

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2014.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hans K Pilegaard, MD, Chief Surgeon principal investigator

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

Kasper Grosen, RN, MHScS, PhDS study director

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

Vibeke Hjortdal, MD, Professor, DMSc, PhD study chair

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Gabapentin in people with Pain, Postoperative, run by University of Aarhus at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Persistent post surgical pain (time frame: 3 months after surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01116583.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2014.