AnalgesiaNCT04675671
Analgesic and Anxiety Efficacy of Preemptive Pregabalin
An observational study of Analgesia and Anxiety, run by Selcuk University at 2 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesia, Anxiety, Arthroscopic Shoulder Surgery
- What is being tested?
- Preoperative and postoperative anxiety measurement [Spielberger's State Anxiety Scale (STAI-S)] and [ Spielberg's State-Trait Anxiety Inventory (STAI-T) ]
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Dec 2019to 15 Mar 2021
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- American society of Anesthesiologists (ASA) grade I or II
- Aged 18-65 years
- Scheduled for elective Arthroscopic shoulder surgery (Bankart or rotator cuff repair)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Selcuk University, School of Medicine
Konya, 42080
Selcuk University, School of Medicine
Konya, 42250
About this study
Official title: Analgesic and Anxiety Efficacy of Preemptive Pregabalin Administration in Arthroscopic Shoulder Surgery: a Prospective Randomized Controlled Trial
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.
Read the detailed 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.
- Conditions
- Analgesia, Anxiety, Arthroscopic Shoulder Surgery
- Being tested
- Preoperative and postoperative anxiety measurement [Spielberger's State Anxiety Scale (STAI-S)] and [ Spielberg's State-Trait Anxiety Inventory (STAI-T) ]
- Medical subject headings
- Agnosia, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative and postoperative anxiety measurement [Spielberger's State Anxiety Scale (STAI-S)] and [ Spielberg's State-Trait Anxiety Inventory (STAI-T) ]Other
Also called postoperative pain
The postoperative pain is measured and evaluated by Visual Analog Scale (VAS= 0 = no pain to 10 = worst pain)
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin group (Group P) | Group pregabalin patients will be received 75 mg of pregabalin twice daily for 2 days before surgery Receives: 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 Receives: Other: Preoperative and postoperative anxiety measurement [Spielberger's State Anxiety Scale (STAI-S)] and [ Spielberg's State-Trait Anxiety Inventory (STAI-T) ] |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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,
Measured: postoperative within 24 hours
Secondary outcomes (2)
The time to first requirement for analgesia is the second outcome.
It will be measured within 48 hours postoperatively
Measured: 48 hours
The total amount of morphine consumed
It will be measured within 48 hours postoperatively
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start1 Dec 2019
- Primary completion3 Mar 2021 (estimated)
- Study completion15 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faruk Cicekci, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04675671
- Sponsor's protocol ID
- farukcicekci4
- Status last verified
- Dec 2020
- First submitted
- 11 Dec 2020
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic and Anxiety Efficacy of Preemptive Pregabalin Administration in Arthroscopic Shoulder Surgery: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04675671
- Acronym / sponsor ID
- farukcicekci4
- Conditions
- Analgesia, Anxiety, Arthroscopic Shoulder Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 3 Mar 2021 (estimated)
- Study completion
- 15 Mar 2021 (estimated)
- First posted
- 19 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregabalin group (Group P) | – | Other: Preoperative and postoperative anxiety measurement [Spielberger's State Anxiety Scale (STAI-S)] and [ Spielberg's State-Trait Anxiety Inventory (STAI-T) ]Group pregabalin patients will be received 75 mg of pregabalin twice daily for 2 days before surgery |
| Control group (Group C) | – | Other: Preoperative and postoperative anxiety measurement [Spielberger's State Anxiety Scale (STAI-S)] and [ Spielberg's State-Trait Anxiety Inventory (STAI-T) ]The Control group will be received plasebo capsule mg at the same point in time |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- American society of Anesthesiologists (ASA) grade I or II
- Aged 18-65 years
- Scheduled for elective Arthroscopic shoulder surgery (Bankart or rotator cuff repair)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative and postoperative anxiety measurement [Spielberger's State Anxiety Scale (STAI-S)] and [ Spielberg's State-Trait Anxiety Inventory (STAI-T) ]Also: postoperative painThe postoperative pain is measured and evaluated by Visual Analog Scale (VAS= 0 = no pain to 10 = worst pain) | Other | Control group (Group C), Pregabalin group (Group P) |
Primary outcome
Preoperative anxiety measurement [Spielberger's State Anxiety Scale (STAI-S)]
Time frame: Preoperatif 4 hours before
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.
Preoperative anxiety measurement [Spielberger's State Anxiety Scale (STAI-T)]
Time frame: Preoperatif 4 hours before
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.
Preoperative anxiety measurement [Spielberger's State Anxiety Scale (STAI-S)
Time frame: postoperative within 24 hours
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.
The postoperative pain will be measured by Visual Analog Scale (VAS)
Time frame: postoperative within 24 hours
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,
2 secondary outcomes
The time to first requirement for analgesia is the second outcome.
Time frame: 48 hours
The total amount of morphine consumed
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Analgesia and Anxiety, run by Selcuk University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative anxiety measurement [Spielberger's State Anxiety Scale (STAI-S)] (time frame: Preoperatif 4 hours before). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2020.