A Phase 4 interventional study of Gabapentin and Placebo in Pain, Postoperative and Surgery, Thoracic, sponsored by National Institute for Tuberculosis and Lung Diseases, Poland. Completed at 1 site in Poland. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2021-09-08.
Sponsored by National Institute for Tuberculosis and Lung Diseases, Poland · Phase 4, Interventional, and Treatment
Among 60 studies testing gabapentin in Pain, Postoperative — 8 open to participants now, 10 under way, 3 of them phase 3. Gabapentin · Pain, Postoperative.
Among the 60 studies testing gabapentin in Pain, Postoperative, this one is the 17th largest by enrollment, is one of 4 that started in 2017, is one of 25 in phase 4, and was the 33rd registered.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's enrollment of 104 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →8 of the 60 studies testing gabapentin in Pain, Postoperative are open now, in 2 countries. Each count lists the studies.
Gabapentin: first FDA approval 1993 (NEURONTIN). What it is approved for, and how studies give it, is on its page →
Of the 679 Pain, Postoperative studies recruiting now, 241 (35%) set no upper age limit and 328 (48%) stop at 75 or younger; 74 take children under 18; 128 take healthy volunteers.
This study: 5 Years to 18 Years · all sexes · no healthy volunteers.
The full table on the hub →60 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 4 started in 2017.
Median enrollment 66 across the 60 interventional studies. Of the 43 that completed or were terminated, 19 (44%) have results posted.
None of the 60 has an industry lead sponsor. The 10 most frequent:
National Institute for Tuberculosis and Lung Diseases, Poland is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
National Institute for Tuberculosis and Lung Diseases, Poland has 3 studies filed under Pain, Postoperative — fewer than ten, so there is no comparison to draw.
6 of the studies testing gabapentin in Pain, Postoperative that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07047040Phase 3Assiut UniversityAnalgesic Efficacy of Pre-operative Dose of Ketorolac and Gabapentin | 2027-10-30 |
| NCT04860141Loma Linda UniversityEfficacy of Preoperative Administration of Gabapentin in 3rd Molar Dental Extraction. | 2026-12 |
| NCT06379425Northwell HealthImpact of Preoperative Opioid-free Multimodal Analgesia on Time to Trial of Void in Ambulatory Urogynecologic Surgeries | 2027-01-01 |
| NCT06997016Baylor Research InstituteEnhanced Recovery After Surgery (ERAS) in Live Donor Kidney Transplant Recipients | 2027-06 |
| NCT07840183Northwestern UniversityEpidural Analgesia Versus Opioid-sparing Analgesia for Open Ventral Hernia Repair With Transversus Abdominis Release | 2027-09 |
Among the 60 studies testing gabapentin in Pain, Postoperative, from their registry updates:
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.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
1. Single dose preoperative gabapentin. 2. After surgery gabapentin 2 times per day for 3 days.
Drug: Gabapentin
1. Single dose preoperative placebo control. 2. After surgery placebo 2 times per day for 3 days.
Drug: Placebo
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.
Also known as: Gabapentin TEVA, capsules
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.
Pain intensity scores at rest (FLACC for patients <7 y.o., NRS for patients >7 y.o.)
Time frame: postoperative day: 0-3
Pain intensity scores during deep breathing (FLACC for patients <7 y.o., NRS for patients >7 y.o.)
Time frame: postoperative day: 0-3
Pain intensity scores during coughing (FLACC for patients <7 y.o., NRS for patients >7 y.o.)
Time frame: postoperative day: 0-3
Total ropivacaine/fentanyl consumption.
Time frame: postoperative day: 0-3
Total morphine consumption.
Time frame: postoperative day: 0-3
Anxiety intensity scores.
Patients rate their anxiety using State-Trait Anxiety Inventory.
Time frame: before surgery, postoperative day 3
Side Effect Occurrence
Incidence and severity of nausea, vomiting, pruritis, sedation, dizziness, urinary retention, complication in relation to administering of the drugs to epidural space.
Time frame: first 3 days after surgery
The number of doses of metamizol as a "rescue drug"
Time frame: postoperative day: 0-3
Patient satisfaction.
Responses can range from 0 (very dissatisfied) to 10 (very satisfied).
Time frame: first 3 days after surgery
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Gabapentin
National Institute for Tuberculosis and Lung Diseases, Poland