Pain, Postoperative
Conditions
Keywords
Gabapentin, Thoracotomy, Pain, Postoperative, Analgesia, Recovery of Function, Quality of Life
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
Interventions
DRUGGabapentin
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)
DRUGPlacebo
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
Sponsors
Aarhus University Hospital Skejby
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Persistent post surgical pain | 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 | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Health related quality of life | Day 14 (+/-3 days) following discharge | 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. |
| Time to first request for additional analgesics | Within the first 5 postoperative days | — |
| 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). |
| Hospital length of stay (days) | At time of discharge | — |
| Use of a vasopressor agent to correct hypotension | Within the first 5 days of surgery | — |
| Sleep quality | Within the first five postoperative days | Sleep quality is measured on a 11-point numeric rating scale (NRS) |
| Consumption of opioid analgesics | Within the first 5 postoperative days | — |
| 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 |
| Convalescence of gastrointestinal function | Within the first 5 postoperative days | Convalescence of gastrointestinal function (time to first defecation) |
Countries
Denmark
Outcome results
None listed