Anxiety Clinical Trial
Official title:
Analgesic and Anxiety Efficacy of Preemptive Pregabalin Administration in Arthroscopic Shoulder Surgery: a Prospective Randomized Controlled Trial
Verified date | December 2020 |
Source | Selcuk University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Active, not recruiting |
Enrollment | 60 |
Est. completion date | March 15, 2021 |
Est. primary completion date | March 3, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - American society of Anesthesiologists (ASA) grade I or II - Aged 18-65 years - Scheduled for elective Arthroscopic shoulder surgery (Bankart or rotator cuff repair) Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Selcuk University, School of Medicine | Konya | |
Turkey | Selcuk University, School of Medicine | Konya |
Lead Sponsor | Collaborator |
---|---|
Selcuk University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | The time to first requirement for analgesia is the second outcome. | It will be measured within 48 hours postoperatively | 48 hours | |
Secondary | The total amount of morphine consumed | It will be measured within 48 hours postoperatively | 48 hours |
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