Evidence map›Paper›PMID 37349841›Full record

ArticleTrials2023

Pregabalin as an effective treatment for acute postoperative pain following spinal surgery without major side effects: protocol for a prospective, randomized controlled, double-blinded trial.

Ki-Hoon Park, Nam-Su Chung, Hee-Woong Chung, Tae Young Kim, Han-Dong Lee

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05478382 (Efficacy and Side Effect Profile of Varying Dose of Pregabalin for the Treatment of Acute Postoperative Pain Following Spinal Surgery), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.3field-weighted citation impact, top 20% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05478382 phase4unknown statusnot on this map

Efficacy and Side Effect Profile of Varying Dose of Pregabalin for the Treatment of Acute Postoperative Pain Following Spinal Surgery

TypeinterventionalSponsorAjou University School of MedicineRan2022 to 2025Enrolled132ConditionsPostoperative Pain, Pregabalin, Spine Surgery, Adverse Reaction to PregabalinArmsPregabalin 25 MG, Placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 1 institution in 1 country.

Ki-Hoon ParkDepartment of Orthopaedic Surgery, Ajou University School of Medicine, Suwon, South Korea.
Nam-Su ChungDepartment of Orthopaedic Surgery, Ajou University School of Medicine, Suwon, South Korea.
Hee-Woong ChungDepartment of Orthopaedic Surgery, Ajou University School of Medicine, Suwon, South Korea.
Tae Young KimDepartment of Orthopaedic Surgery, Ajou University School of Medicine, Suwon, South Korea.
Han-Dong LeeDepartment of Orthopaedic Surgery, Ajou University School of Medicine, Suwon, South Korea. handonglee@gmail.com.
Ajou University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients experience considerable postoperative pain after spinal surgery. As the spine is located at the centre of the body and supports body weight, severe postoperative pain hinders upper body elevation and gait which can lead to various complications, including pulmonary deterioration and pressure sores. It is important to effectively control postoperative pain to prevent such complications. Gabapentinoids are widely used as preemptive multimodal analgesia, but their effects and side effects are dose-dependent. This study was designed to examine the efficacy and side effects of varying doses of postoperative pregabalin for the treatment of postoperative pain after spinal surgery.

methodsThis is a prospective, randomized controlled, double-blind study. A total of 132 participants will be randomly assigned to the placebo (n = 33) group or to the pregabalin 25 mg (n = 33), 50 mg (n = 33), or 75 mg (n = 33) groups. Each participant will be administered placebo or pregabalin once prior to surgery and every 12 h after surgery for 72 h. The primary outcome will be the visual analogue scale pain score, total dose of administered intravenous patient-controlled analgesia, and frequency of rescue analgesic administered for 72 h from arrival to the general ward after surgery, subdivided into four periods: 1-6 h, 6-24 h, 24-48 h, and 48-72 h. The secondary outcomes will be the incidence and frequency of nausea and vomiting due to intravenous patient-controlled analgesia. Safety will be assessed by monitoring the occurrence of side effects such as sedation, dizziness, headache, visual disturbance, and swelling. DISCUSSION: Pregabalin is already widely used as preemptive analgesia and, unlike nonsteroidal anti-inflammatory drugs, is not associated with a risk of nonunion after spinal surgery. A recent meta-analysis demonstrated the analgesic efficacy and opioid-sparing effect of gabapentinoids with significantly decreased risks of nausea, vomiting, and pruritus. This study will provide evidence for the optimal dosage of pregabalin for the treatment of postoperative pain after spinal surgery.

trial registrationClinicalTrials.gov NCT05478382. Registered on 26 July 2022.

Indexed as

AnalgesicsDouble-Blind MethodHumansNauseaPostoperative PainPregabalinProspective StudiesRandomized Controlled Trials as TopicVomitingAnalgesicsPregabalinGabapentinoidPostoperative painPregabalinSpinal surgery

Identifiers

PMID37349841
PMCPMC10286380
OpenAlexW4381684213

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.