Analgesic and Anxiety Efficacy of Preemptive Pregabalin

Anxiety Clinical Trial

Official title:

Analgesic and Anxiety Efficacy of Preemptive Pregabalin Administration in Arthroscopic Shoulder Surgery: a Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04675671
• Other study ID #: farukcicekci4
• Status: Active, not recruiting
• Start date: December 1, 2019
• Est. completion date: March 15, 2021

Study information

• Verified date: December 2020
• Source: Selcuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

One day before the scheduled surgery, a staff who was not included in this study will assign patients to the random Pregabalin group (n = 30) and the Control group (n = 30) according to a will be computerized randomization table. The hospital pharmacy will prepare all medications in same capsules, and all the medications of study drug will performe by a nurse, who was not involved in other process of this study administered the capsules orally with sips of water. Group pregabalin patients will receive 75 mg of pregabalin twice daily for 2 days before surgery. the Control group will receive plasebo capsule mg at the same point in time. The last doses one hour before induction of anesthesia. The double-blind design in this study included blinding of anesthesiologist, orthopedic surgeon, nurse giving the drugs, and the patients. No other sedative premedication will be given to all patients. Anesthesia will induce with propofol 2 mg.kg-1and remifentanil 0.5-1 µg.kg-1, and tracheal intubation will facilitate with rocuronium 0.6 mg.kg-1. Anesthesia will maintaine with a continuous infusion of remifentanil 0.05-0.2 µg.kg-1.min-1 and sevoflurane 2-2.5 vol% to maintain a bispectral index scale (BIS) values of 40 to 60. All surgeries will be performed by an experienced orthopedic surgeon. At the end of the surgery, sevoflurane and remifentanil will stop and residual neuromuscular paralysis will antagonize, and extubation will performe when the patient had sufficient expiration. Age, gender, body mass index, the duration of anesthesia surgery and the type of surgery will record. In the preoperative period, and duration of operation will be measured.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Analgesia
• Anxiety
• Anxiety Disorders
• Arthroscopic Shoulder Surgery

Intervention

Other:
• Preoperative and postoperative anxiety measurement [Spielberger's State Anxiety Scale (STAI-S)] and [ Spielberg's State-Trait Anxiety Inventory (STAI-T) ]
The postoperative pain is measured and evaluated by Visual Analog Scale (VAS= 0 = no pain to 10 = worst pain)

Locations

Country	Name	City	State
Turkey	Selcuk University, School of Medicine	Konya
Turkey	Selcuk University, School of Medicine	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

Outcome

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