Pain, Postoperative, Surgery, Thoracic
Conditions
Keywords
Postoperative pain, Anxiety, Postoperative Complications, Patient Satisfaction
Brief summary
The study is performed in patients aged 5-18 years after thoracic surgery. The primary aim of this trial is to determine whether the use of gabapentin as a component of multimodal analgesic regiments reduces pain scores following thoracic surgery in pediatric patients. The secondary objective of the trial are to evaluate whether the use of gabapentin reduces postoperative anxiety scores and consumption of ropivacaine with fentanyl, decreases side-effects, and improves patient satisfaction.
Detailed description
The subjects are randomized to the Gabapentin or Placebo group. All patients receive preoperative gabapentin (15 mg/kg, treatment) or placebo, respectively and after surgery either gabapentin (7,5 mg/kg, treatment) or placebo 2 times per day for 3 days, respectively. Patients are subjected to the same anaesthesia protocol. Postoperative analgesia are achieved with either continuous ropivacaine 0.2%/fentanyl 5.0 μg/ml infusion through a thoracic epidural catheter (N=40; Gabapentin n=20, Placebo n=20), or intravenous infusion of morphine (N=40; Gabapentin n=20, Placebo n=20). All patients receive acetaminophen and non-steroidal anti-inflammatory drugs, and metamizol as a rescue drug The intravenous infusion of morphine grup was expanded on the basis of the bioethics commission's decision KB-125/2019 (N=64; Gabapentin n=32, Placebo n=32).
Interventions
DRUGGabapentin
1. Patients in this arm of the study receive identical capsules, containing 15 mg/kg of oral gabapentin. 2. Patients after surgery receive identical capsules, containing 7,5 mg/kg of oral gabapentin 2 times per day.
DRUGPlacebo
1. Patients in this arm of the study receive identical placebo capsules 1 hour before surgery. 2. Patients after surgery receive identical placebo capsules 2 times per day.
Sponsors
National Institute for Tuberculosis and Lung Diseases, Poland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* 5 - 18 years of age; * surgery: lateral thoracotomy or Ravitch procedure; * ASA 1-3; * postoperative analgesia: thoracic epidural analgesia or intravenous infusion of morphine.
Exclusion criteria
* allergy or sensitivity to gabapentin; * history of chronic pain or daily analgesic use; * diagnosed with psychiatric disorders; * treated oncologically; * with impaired verbal communication; * the lack of postoperative chest drainage.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain intensity scores at rest (FLACC for patients <7 y.o., NRS for patients >7 y.o.) | postoperative day: 0-3 |
| Pain intensity scores during deep breathing (FLACC for patients <7 y.o., NRS for patients >7 y.o.) | postoperative day: 0-3 |
| Pain intensity scores during coughing (FLACC for patients <7 y.o., NRS for patients >7 y.o.) | postoperative day: 0-3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side Effect Occurrence | first 3 days after surgery | Incidence and severity of nausea, vomiting, pruritis, sedation, dizziness, urinary retention, complication in relation to administering of the drugs to epidural space. |
| Total ropivacaine/fentanyl consumption. | postoperative day: 0-3 | — |
| Patient satisfaction. | first 3 days after surgery | Responses can range from 0 (very dissatisfied) to 10 (very satisfied). |
| The number of doses of metamizol as a rescue drug | postoperative day: 0-3 | — |
| Total morphine consumption. | postoperative day: 0-3 | — |
| Anxiety intensity scores. | before surgery, postoperative day 3 | Patients rate their anxiety using State-Trait Anxiety Inventory. |
Countries
Poland
Outcome results
None listed