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Evaluation of Gabapentin as a drug that helps in postoperative pain management of Knee Surgery

Gabapentin as an adjuvant in the management of pain in the postoperative of Anterior Cruciate Ligament surgeries: a double, blind, randomized and controlled study - ACL Anterior cruciate ligament

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3zvc3s
Enrollment
Unknown
Registered
2019-08-21
Start date
2021-10-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sprain and strain involving (anterior) (posterior) cruciate ligament of knee

Interventions

The case group and the control group will have 25 participants in each. The patient should start using gabapentin (or Placebo) 18 hours before surgery, at a dose of 900mg per day divided into 3 equal
and tramadol 50mg (tablets), varying according to the patients pain, with a recommendation to take a maximum of 2 tablets 4 times a day.

Sponsors

Instituto de Ortopedia e Traumatologia de Joinville
Lead Sponsor
Instituto de Ortopedia e Traumatologia de Joinville
Collaborator

Eligibility

Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Patients of both genders, aged between 18 and 50 years; with single lesion of the unilateral Anterior Cruciate Ligament; who undergo surgical treatment of a single lesion of the Anterior Cruciate Ligament.

Exclusion criteria

Exclusion criteria: Patients who present allergy to Gabapentin, Tramadol, Dipyrone or Nimesulide (prior or during the study); Renal or Hepatic Insufficiency; patients with recent previous use of anticonvulsants, opioids, or antidepressant agents; or who are being treated with cimetidine or antacids for any reason; associated chondral lesion; injury of another associated ligament; associated meniscal injury; diabetes mellitus; fibromyalgia; chronic pain; depressive disorder, bipolar disorder, generalized anxiety disorder; history of illegal substance use or alcohol abuse; non-literate patients and those who do not agree to sign the Informed Consent Form.

Design outcomes

Primary

MeasureTime frame
1. Patients receiving Gabapentin in the Multimodal Analgesia scheme (Gabapentin Group) will consume fewer opioids in the recent postoperative period than patients who received Placebo in the same Multimodal Analgesia scheme (Placebo Group).

Secondary

MeasureTime frame
1. Patients in the Gabapentin Group will present lower scores on the Pain Scales compared to those in the Placebo Group. 2. Gabapentin Group patients will have fewer adverse effects than Placebo Group patients.

Countries

Brazil

Contacts

Public ContactAna Paula Ferreira

Instituto de Ortopedia e Traumatologia de Joinville

apbonilauri@gmail.com+55 47 30438534

Outcome results

None listed

Source: REBEC (via WHO ICTRP)