Effect of Pregabalin or Adductor Canal Block on Postoperative Analgesia

• ClinicalTrials.gov Identifier: NCT03530280
• Recruitment Status: Completed
• First Posted: May 21, 2018
• Last Update Posted: October 18, 2019
• Sponsor: Ankara Diskapi Training and Research Hospital
• Information provided by (Responsible Party): Fatma Kavak Akelma, Ankara Diskapi Training and Research Hospital

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Postoperative Pain After Knee Arthroscopy	Drug: pregabalin (lyrica); Drug: Placebo oral tablet; Drug: adductor canal block including bupivacaine	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 51 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: Effect of Pregabalin or Adductor Canal Block on Postoperative Analgesia After Arthroscopic Anterior Cruciate Ligament Reconstruction (ACL)
• Actual Study Start Date: June 1, 2018
• Actual Primary Completion Date: October 1, 2018
• Actual Study Completion Date: December 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 11-point numerical rating scale (NRS) [ Time Frame: 24 hours ]
   11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained.
2. tramadol consumption [ Time Frame: 24 hours ]
   24 hours tramadol consumption will be recorded as milligrams

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Turkey

Diskapi Teaching and Research Hospital

Ankara, Altindag, Turkey

Sponsors and Collaborators

Ankara Diskapi Training and Research Hospital

More Information

• Responsible Party: Fatma Kavak Akelma, specialist doctor, Ankara Diskapi Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT03530280
• Other Study ID Numbers: pregabalin
• First Posted: May 21, 2018
• Last Update Posted: October 18, 2019
• Last Verified: October 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fatma Kavak Akelma, Ankara Diskapi Training and Research Hospital:

pregabalin; adductor canal block; postoperative pain

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Pregabalin; Bupivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Analgesics; Anticonvulsants; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Calcium-Regulating Hormones and Agents; Anti-Anxiety Agents; Tranquilizing Agents; Psychotropic Drugs