Analgesic and Anxiety Efficacy of Preemptive Pregabalin

NCT04675671 | Unknown

• 1 other identifier: farukcicekci4
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Effective postoperative pain control after arthroscopic shoulder surgery optimizes postoperative rehabilitation, reduces anxiety, and can increase patient satisfaction and postoperative healing by providing amnesia and sedation. Few literature is available for postoperative pain management, including intra-articular local anesthetic infiltration, regional nerve blocks, patient-controlled analgesia (PCA) with intravenous opioid, and oral nonsteroidal anti-inflammatory and gabapentinoid drugs. Recently, gabapentinoides such as pregabalin have also shown to have potential in the treatment of acute postoperative pain as part of multimodal analgesia, due to their possible opioid consumption-reducing effects and prevention of post-surgical chronic pain. Pregabalin is an anticonvulsant drug that reduces calcium entry into the nerve terminals of the central nerve and also reduces levels of substance P, glutamate and noradrenaline, all of which play a major role in creating a feeling of pain. It is well known that pregabalin reduces central sensitization and hyperalgesia after tissue injury by inhibiting calcium influx in voltage-gated calcium channels. These theoretical advantages have led to clinical trials to confirm the analgesic effectiveness of oral pregabalin for postoperative pain management in various surgical procedures.

Conditions

Analgesia; Anxiety; Arthroscopic Shoulder Surgery

Outcome Measures

Primary Outcomes (4)

• Preoperative anxiety measurement [Spielberger's State Anxiety Scale (STAI-S)]

  STAI-S consist of 20 items with four points Likert scales, each (not at all, somewhat, moderately so, very much so). Scores thus range between 20, indicating a low level of anxiety and 80, indicating a high level.

  Preoperatif 4 hours before

• Preoperative anxiety measurement [Spielberger's State Anxiety Scale (STAI-T)]

  STAI-T consist of 20 items with four points Likert scales, each (not at all, somewhat, moderately so, very much so). Scores thus range between 20, indicating a low level of anxiety and 80, indicating a high level.

  Preoperatif 4 hours before

• Preoperative anxiety measurement [Spielberger's State Anxiety Scale (STAI-S)

  STAI-S consist of 20 items with four points Likert scales, each (not at all, somewhat, moderately so, very much so). Scores thus range between 20, indicating a low level of anxiety and 80, indicating a high level.

  postoperative within 24 hours

• The postoperative pain will be measured by Visual Analog Scale (VAS)

  Visual Analog Scale will be evaluated between VAS= 0 (no pain) and VAS=10 levels (worst pain).This parameter is measured from 10mins, 30 mins, 1 hour, 3 hours, 6 hours, 12 hours and 24 hours post-operatively,

  postoperative within 24 hours

Secondary Outcomes (2)

• The time to first requirement for analgesia is the second outcome.

  48 hours

• The total amount of morphine consumed

  48 hours

Study Arms (2)

Pregabalin group (Group P)

Group pregabalin patients will be received 75 mg of pregabalin twice daily for 2 days before surgery

Other: Preoperative and postoperative anxiety measurement [Spielberger's State Anxiety Scale (STAI-S)] and [ Spielberg's State-Trait Anxiety Inventory (STAI-T) ]

Control group (Group C)

The Control group will be received plasebo capsule mg at the same point in time

Other: Preoperative and postoperative anxiety measurement [Spielberger's State Anxiety Scale (STAI-S)] and [ Spielberg's State-Trait Anxiety Inventory (STAI-T) ]

Interventions

Preoperative and postoperative anxiety measurement [Spielberger's State Anxiety Scale (STAI-S)] and [ Spielberg's State-Trait Anxiety Inventory (STAI-T) ] OTHER

The postoperative pain is measured and evaluated by Visual Analog Scale (VAS= 0 = no pain to 10 = worst pain)

Also known as: postoperative pain

Control group (Group C); Pregabalin group (Group P)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study will be scheduled patients of American society of Anesthesiologists (ASA) grade I or II, aged 18-65 years, and scheduled for elective Arthroscopic shoulder surgery (Bankart or rotator cuff repair) under general anesthesia

You may qualify if:

• American society of Anesthesiologists (ASA) grade I or II
• Aged 18-65 years
• Scheduled for elective Arthroscopic shoulder surgery (Bankart or rotator cuff repair)

You may not qualify if:

• Major neurological, cardiovascular, metabolic, respiratory, renal disease or coagulation abnormalities
• Body mass index over 40 kg / m2
• Chronic alcohol and substance use
• History of upper gastrointestinal bleeding or perforation
• Using more than 5 mg / day of oral morphine or equivalent opioids (more than 1 month)
• Patients who are allergic to the drugs used

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (2)

Selcuk University, School of Medicine

Konya, 42080, Turkey (Türkiye)

Location

Selcuk University, School of Medicine

Konya, 42250, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia; Anxiety Disorders

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 19, 2020
• Study Start: December 1, 2019
• Primary Completion: March 3, 2021
• Study Completion: March 15, 2021
• Last Updated: December 19, 2020

Record last verified: 2020-12

Locations

TU (2)