Effect of Pregabalin or Adductor Canal Block on Postoperative Analgesia

Effect of Pregabalin or Adductor Canal Block on Postoperative Analgesia After Arthroscopic Anterior Cruciate Ligament Reconstruction (ACL)

arthroscopically Anterior Cruciate Ligament Reconstruction (ACL) under spinal anesthesia were included in this study.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain After Knee Arthroscopy
• Intervention / Treatment: Drug: pregabalin (lyrica); Drug: Placebo oral tablet; Drug: adductor canal block including bupivacaine

Detailed Description

Patients who American Society of Anesthesiologists (ASA) classification I to II scheduled to undergo arthroscopically assisted ACL reconstructions under spinal anesthesia are included in this study. The first group is administered 150 mg oral pregabalin 1 hour before surgery and the postoperative sham block was performed with an ultrasound probe. The second group is the control group; patients in this group are administered a placebo capsule 1 hour before surgery and sham block was performed with an ultrasound probe.The third group is administered a placebo capsule 1 hour before surgery and postoperative adductor canal block is performed. All patients will be received postoperative a tramadol i.v. patient control analgesia device. At the end of 24 hours, the total amount of tramadol consumed by the patient will be recorded from the patient control analgesia. NRS score, white fast track, satisfaction will be questioned.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Altindag
    • Ankara, Altindag, Turkey
      • Diskapi Teaching and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients between the ages of 18 and 70 years
• American Society of Anesthesiologists I or II
• Scheduled to undergo knee arthroscopy

Exclusion Criteria:

• allergic to any medicines
• History of drug or alcohol abuse,
• Opioids or sedative medications
• History of psychiatric conditions
• Pregnant or lactating women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: pregabalin (lyrica); pregabalin (lyrica) 150 mg preoperative 1 hour before and the postoperative sham block will perform.	Drug: pregabalin (lyrica); preoperative pregabalin and the postoperative sham block will perform.
Placebo Comparator: placebo group; a placebo capsule 1 hour before surgery and the postoperative sham block will perform.	Drug: Placebo oral tablet; The preoperative placebo oral tablet and the postoperative sham block will perform.
Active Comparator: adductor channel block group; A preoperative placebo capsule will be given.This group will receive postoperative adductor channel block including 10 mL of 0.25% bupivacaine with 5 μg/mL epinephrine	Drug: adductor canal block including bupivacaine; The preoperative placebo oral tablet and adductor channel block including 10 mL of 0.25% bupivacaine with 5 μg/mL epinephrine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
11-point numerical rating scale (NRS)	11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained.	24 hours
tramadol consumption	24 hours tramadol consumption will be recorded as milligrams	24 hours

Collaborators and Investigators

• Sponsor: Ankara Diskapi Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: March 26, 2018
• First Submitted That Met QC Criteria: May 18, 2018
• First Posted (Actual): May 21, 2018

Study Record Updates

• Last Update Posted (Actual): October 18, 2019
• Last Update Submitted That Met QC Criteria: October 16, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: pregabalin; postoperative pain; adductor canal block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Anesthetics, Local; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin; Bupivacaine
• Other Study ID Numbers: pregabalin

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No