Postoperative PainPhase 3GABATHOMIENCT03158376
Preoperative Gabapentin for Chronic Pain After Thoracotomy (GABATHOMIE).
A Phase 3 study testing Gabapentin in people with Postoperative Pain and Chronic Pain, run by University Hospital, Lille at 1 site in France.
Trial summary
To assess the effects of prolonged preoperative gabapentin treatment (10 days) on chronic pain after thoracotomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Chronic Pain
- What is being tested?
- Gabapentin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 201 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to 24 May 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 years
- elective lung resection via thoracotomy
Who cannot join
- extended pleurectomy and chest wall resection
- previous ipsilateral thoracotomy
- previous ipsilateral radiotherapy
- thoracotomy for pyothorax
- chest injury
- palliative surgery
Show all 18Show fewer
- contraindicated placement of a thoracic epidural catheter
- allergy to medications on protocol
- pre-existing pain syndrome
- current treatment with morphine, gabapentin, pregabalin, anticonvulsivants or tricyclic antidepressants
- a history of past or current drug addiction
- severe hepatic, renal or cardiovascular disorders
- inability to understand the study protocol or to answer the questionnaires on pain and quality of life
- severe psychiatric disorders
- incompetent adults under some form of guardianship
- refusal of the protocol
- persons without social security coverage
- pregnant or lactating woman
Trial locations and contacts
1 site in 1 country.
France1 site
Department of Thoracic Surgery, Lille University Hospital
Lille, 59000
About this study
Official title: Perioperative Gabapentin for Chronic Post-thoracotomy Pain: a Randomized, Double Blind, Placebo-controlled Study.
To assess the effects of prolonged preoperative gabapentin treatment (10 days) on chronic pain after thoracotomy.
Read the detailed description
Randomized, double blind study enrolling 200 adults undergoing thoracotomy. Patients receive either 75 mg hydroxyzine before surgery and placebo 3 times daily for 10 days or 1200 mg gabapentin before surgery continued for 10 days. All patients receive also a thoracic epidural analgesia.
Assessment of chronic pain at 3 month with an evaluation by a physician (pain intensity, pain quality and analgesia requirement).
Assessment of acute pain in the early postoperative period (pain intensity, pain quality and analgesia requirement).
- Conditions
- Postoperative Pain, Chronic Pain
- Being tested
- Gabapentin, Placebo
- Keywords
- gabapentin, thoracotomy, chronic post-thoracotomy pain, acute post-thoracotomy pain, quality of life, neuropathic pain
- Medical subject headings
- Pain, Postoperative, Chronic Pain, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Also called gabapentin Biogaran 400 mg capsule
PlaceboDrug
Also called placebo oral capsule (lactose)
| Study group | Role | What they receive |
|---|---|---|
| gabapentin group | Experimental | * the day before surgery : gabapentin 400 mg orally
* preoperatively (2 hours before surgery) : 3 capsules each containing 400 mg gabapentin (total gabapentin dose 1200 mg) and intravenous infusion of 50 ml of normal saline solution
* postoperative day 1 to 10 : 400 mg x 3 ( gabapentin 1200 mg daily) Receives: Drug: Gabapentin |
| placebo group | Placebo comparator | * The day before surgery: 1 placebo capsule orally
* preoperatively (2 hours before surgery) : 3 placebo capsules and intravenous infusion of 75 mg hydroxyzine
* postoperative day 1 to 10: 1 placebo capsule x 3 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistent chronic post-thoracotomy pain
Pain intensity is measured on a 11-point numeric pain rating scale ; a score >=0 is considered as chronic pain.
Measured: 3 months after surgery
Secondary outcomes (10)
Quantitative pain assessment: Acute postoperative pain intensity
Measured on a 11-point numeric rating scale
Measured: Within the first 10 postoperative days
Quantitative pain assessment: Rescue analgesics requirement
consumption of additional analgesics (opioids, nefopam or non steroidal anti-inflammatory drug) and time to first request.
Measured: Within the first 3 months after surgery
Quantitative pain assessment: volume of epidural infusion
total dose of epidural local anesthetic and epidural morphine
Measured: Within the 5 postoperative days
Qualitative pain assessment: incidence of neuropathic pain
Assessed by DN4 (Neuropathic pain 4), NPSI (Neuropathic Pain Symptom Inventory) and QDSA ( Saint Antoine French questionnaire = McGill questionnaire)
Measured: postoperative day 2
Qualitative pain assessment: incidence of neuropathic pain
Assessed by DN4 (Neuropathic pain 4), NPSI (Neuropathic Pain Symptom Inventory) and QDSA ( Saint Antoine French questionnaire = McGill questionnaire)
Measured: postoperative day 6
Qualitative pain assessment: incidence of neuropathic pain
Assessed by DN4 (Neuropathic pain 4), NPSI (Neuropathic Pain Symptom Inventory) and QDSA ( Saint Antoine French questionnaire = McGill questionnaire)
Measured: 3 months after surgery
Qualitative pain assessment: Rescue analgesics requirement for neuropathic pain
Time to first request and consumption (doses and length of treatment) of gapapentinoids, amitriptyline
Measured: within the first 3 months after surgery
Qualitative pain assessment: Objective assessment of hyperalgesia by the Von Frey filaments test
60 and 300 g Von Frey filaments test on the thoracotomy area
Measured: 3 months after surgery
Heath related quality of life
measured by EQ-5D-5L questionnaire
Measured: 3 months after surgery
Assessment of sedation in the operating room
measured by MOAA/S scale ( Modified Observer's Assessment of alternes/sedation Scale)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study startSep 2015
- Primary completion24 May 2019
- Study completion24 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lille Nord de France
- Responsible party
- Sponsor
- Investigators
- Jacques Desbordes, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03158376
- Sponsor's protocol ID
- 2014_12
- Other IDs
- 2014-005226-35, 2014
- Acronym
- GABATHOMIE
- Status last verified
- Nov 2022
- First submitted
- 16 May 2017
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Gabapentin for Chronic Post-thoracotomy Pain: a Randomized, Double Blind, Placebo-controlled Study.
- ClinicalTrials.gov ID
- NCT03158376
- Acronym / sponsor ID
- GABATHOMIE / 2014_12
- Conditions
- Postoperative Pain, Chronic Pain
- Keywords
- gabapentin, thoracotomy, chronic post-thoracotomy pain, acute post-thoracotomy pain, quality of life, neuropathic pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- University of Lille Nord de France
- Study start
- Sep 2015 (actual)
- Primary completion
- 24 May 2019 (actual)
- Study completion
- 24 May 2019 (actual)
- First posted
- 18 May 2017 (actual)
- 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.
To assess the effects of prolonged preoperative gabapentin treatment (10 days) on chronic pain after thoracotomy.
Detailed description
Randomized, double blind study enrolling 200 adults undergoing thoracotomy. Patients receive either 75 mg hydroxyzine before surgery and placebo 3 times daily for 10 days or 1200 mg gabapentin before surgery continued for 10 days. All patients receive also a thoracic epidural analgesia.
Assessment of chronic pain at 3 month with an evaluation by a physician (pain intensity, pain quality and analgesia requirement).
Assessment of acute pain in the early postoperative period (pain intensity, pain quality and analgesia requirement).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gabapentin group | Experimental | Drug: Gabapentin* the day before surgery : gabapentin 400 mg orally * preoperatively (2 hours before surgery) : 3 capsules each containing 400 mg gabapentin (total gabapentin dose 1200 mg) and intravenous infusion of 50 ml of normal saline solution * postoperative day 1 to 10 : 400 mg x 3 ( gabapentin 1200 mg daily) |
| placebo group | Placebo comparator | Drug: Placebo* The day before surgery: 1 placebo capsule orally * preoperatively (2 hours before surgery) : 3 placebo capsules and intravenous infusion of 75 mg hydroxyzine * postoperative day 1 to 10: 1 placebo capsule x 3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age > 18 years
- elective lung resection via thoracotomy
Key exclusion criteria (18 listed)
- extended pleurectomy and chest wall resection
- previous ipsilateral thoracotomy
- previous ipsilateral radiotherapy
- thoracotomy for pyothorax
- chest injury
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 Biogaran 400 mg capsule | Drug | gabapentin group |
| PlaceboAlso: placebo oral capsule (lactose) | Drug | placebo group |
Primary outcome
Persistent chronic post-thoracotomy pain
Time frame: 3 months after surgery
Pain intensity is measured on a 11-point numeric pain rating scale ; a score >=0 is considered as chronic pain.
10 secondary outcomes
Quantitative pain assessment: Acute postoperative pain intensity
Time frame: Within the first 10 postoperative days
Quantitative pain assessment: Rescue analgesics requirement
Time frame: Within the first 3 months after surgery
Quantitative pain assessment: volume of epidural infusion
Time frame: Within the 5 postoperative days
Qualitative pain assessment: incidence of neuropathic pain
Time frame: postoperative day 2
Qualitative pain assessment: incidence of neuropathic pain
Time frame: postoperative day 6
Qualitative pain assessment: incidence of neuropathic pain
Time frame: 3 months after surgery
Qualitative pain assessment: Rescue analgesics requirement for neuropathic pain
Time frame: within the first 3 months after surgery
Qualitative pain assessment: Objective assessment of hyperalgesia by the Von Frey filaments test
Time frame: 3 months after surgery
Heath related quality of life
Time frame: 3 months after surgery
Assessment of sedation in the operating room
Time frame: baseline
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 4 Nov 2022.
- Individual participant dataSharing planned: No
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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.
Jacques Desbordes, MD principal investigator
University Hospital, Lille
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 Postoperative Pain and Chronic Pain, run by University Hospital, Lille at 1 site in France.
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 18 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 4 Nov 2022. 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 France. 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 chronic post-thoracotomy pain (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2022.