Pain, AcuteesmololNCT05567822
The Impact of Esmolol Administration on Postoperative Recovery
A study testing Esmolol Hydrochloride and normal saline in people with Pain, Acute and Pain, Postoperative, run by Aretaieion University Hospital at 1 site in Greece.
Trial summary
The aim of this study will be to investigate the effect of a continuous infusion of low dose esmolol on intraoperative and postoperative opioid consumption, as well as on postoperative recovery and chronic pain Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain, Acute, Pain, Postoperative, Pain, Chronic Post-Surgical
- What is being tested?
- Esmolol Hydrochloride and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteGreece
- Study dates
- 1 Oct 2022to 1 Oct 2024
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients
- American Society of Anesthesiologists (ASA) classification I-II
- elective inguinal hernia repair
Who cannot join
- body mass index (BMI) >35 kg/m2
- β-blocker administration preoperatively
- systematic use of analgesic agents preoperatively
- chronic pain syndromes preoperatively
- neurological or psychiatric disease on treatment
- pregnancy
Show all 13Show fewer
- severe hepatic or renal disease
- history of cardiovascular diseases/ arrhythmias/ conduction abnormalities
- hemodynamic instability
- drug or alcohol abuse
- language or communication barriers
- lack of informed consent
- bilateral inguinal hernia repair
Trial locations and contacts
1 site in 1 country.
Vasiliki Samartzi contact
Greece1 site, 1 recruiting
- Recruiting
Evangelismos General Hospital
Athens, 10676
Kassiani Theodoraki, DESA, 6974634162, ktheodoraki@hotmail.com
Vasiliki Samartzi, v.samartzi2@gmail.com
About this study
Official title: The Effect of Intraoperative Esmolol Administration on Postoperative Recovery and Chronic Pain
The aim of this study will be to investigate the effect of a continuous infusion of low dose esmolol on intraoperative and postoperative opioid consumption, as well as on postoperative recovery and chronic pain
Read the detailed description
Contemporary anaesthesiology requires the quest of ways to restrict the use of opioids, which aim at the alleviation of severe postoperative and chronic pain. This is not only due to the side effects involved but also to the epidemic dimensions their use entails. Esmolol, an extremely short-acting cardioselective antagonist of β1 adrenergic receptors, is effectively used in order to attenuate the stress response and minimize undesirable perioperative hemodynamic changes. More specifically, esmolol has been used effectively to reduce pain during induction of anesthesia with propofol and treat tachycardia and hypertension during laryngoscopy. However, recent studies also highlight a possible antinociceptive and/or analgesic effect of esmolol. Therefore, The aim of this study will be to investigate the effect of a continuous infusion of low dose esmolol on intraoperative and postoperative opioid consumption, as well as on postoperative recovery and chronic pain
- Conditions
- Pain, Acute, Pain, Postoperative, Pain, Chronic Post-Surgical, Esmolol, Inguinal Hernia Repair, Analgesia
- Being tested
- Esmolol Hydrochloride, normal saline
- Medical subject headings
- Acute Pain, Pain, Postoperative, Agnosia, Nociceptive Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esmolol HydrochlorideDrug
In the esmolol group, patients will receive a bolus dose of esmolol followed by a continuous infusion of esmolol intraoperatively
normal salineDrug
In the placebo group, patients will receive a bolus dose of normal saline followed by a continuous infusion of normal saline intraoperatively
| Study group | Role | What they receive |
|---|---|---|
| esmolol group | Active comparator | loading dose of esmolol 0.05 mL/kg and maintenance dose of esmolol 0.3 mL/kg/h Receives: Drug: Esmolol Hydrochloride |
| placebo group | Placebo comparator | loading dose of 0.9% sodium chloride 0.05 mL/kg and maintenance dose of 0.9% sodium chloride 0.3 mL/kg/h Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score 3 hours postoperatively
pain score by the use of Numeric Rating Scale (NRS) 3 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
Measured: 3 hours postoperatively
pain score 6 hours postoperatively
pain score by the use of Numeric Rating Scale (NRS) 6 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
Measured: 6 hours postoperatively
pain score 24 hours postoperatively
pain score by the use of Numeric Rating Scale (NRS) 24 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start1 Oct 2022
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aretaieion University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Kassiani Theodoraki, Aretaieion University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567822
- Sponsor's protocol ID
- 89/24-03-2022
- Acronym
- esmolol
- Status last verified
- Oct 2022
- First submitted
- 1 Oct 2022
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Egan TD. Are opioids indispensable for general anaesthesia? Br J Anaesth. 2019 Jun;122(6):e127-e135. doi: 10.1016/j.bja.2019.02.018. Epub 2019 Mar 28.
PubMed 31104756Salome A, Harkouk H, Fletcher D, Martinez V. Opioid-Free Anesthesia Benefit-Risk Balance: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Clin Med. 2021 May 12;10(10):2069. doi: 10.3390/jcm10102069.
PubMed 34065937Bahr MP, Williams BA. Esmolol, Antinociception, and Its Potential Opioid-Sparing Role in Routine Anesthesia Care. Reg Anesth Pain Med. 2018 Nov;43(8):815-818. doi: 10.1097/AAP.0000000000000873.
PubMed 30216240Gelineau AM, King MR, Ladha KS, Burns SM, Houle T, Anderson TA. Intraoperative Esmolol as an Adjunct for Perioperative Opioid and Postoperative Pain Reduction: A Systematic Review, Meta-analysis, and Meta-regression. Anesth Analg. 2018 Mar;126(3):1035-1049. doi: 10.1213/ANE.0000000000002469.
PubMed 29028742Watts R, Thiruvenkatarajan V, Calvert M, Newcombe G, van Wijk RM. The effect of perioperative esmolol on early postoperative pain: A systematic review and meta-analysis. J Anaesthesiol Clin Pharmacol. 2017 Jan-Mar;33(1):28-39. doi: 10.4103/0970-9185.202182.
PubMed 28413270Andresen K, Rosenberg J. Management of chronic pain after hernia repair. J Pain Res. 2018 Apr 5;11:675-681. doi: 10.2147/JPR.S127820. eCollection 2018.
PubMed 29670394
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intraoperative Esmolol Administration on Postoperative Recovery and Chronic Pain
- ClinicalTrials.gov ID
- NCT05567822
- Acronym / sponsor ID
- esmolol / 89/24-03-2022
- Conditions
- Pain, Acute, Pain, Postoperative, Pain, Chronic Post-Surgical, Esmolol, Inguinal Hernia Repair, Analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Aretaieion University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 5 Oct 2022 (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.
The aim of this study will be to investigate the effect of a continuous infusion of low dose esmolol on intraoperative and postoperative opioid consumption, as well as on postoperative recovery and chronic pain
Detailed description
Contemporary anaesthesiology requires the quest of ways to restrict the use of opioids, which aim at the alleviation of severe postoperative and chronic pain. This is not only due to the side effects involved but also to the epidemic dimensions their use entails. Esmolol, an extremely short-acting cardioselective antagonist of β1 adrenergic receptors, is effectively used in order to attenuate the stress response and minimize undesirable perioperative hemodynamic changes. More specifically, esmolol has been used effectively to reduce pain during induction of anesthesia with propofol and treat tachycardia and hypertension during laryngoscopy. However, recent studies also highlight a possible antinociceptive and/or analgesic effect of esmolol. Therefore, The aim of this study will be to investigate the effect of a continuous infusion of low dose esmolol on intraoperative and postoperative opioid consumption, as well as on postoperative recovery and chronic pain
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| esmolol group | Active comparator | Drug: Esmolol Hydrochlorideloading dose of esmolol 0.05 mL/kg and maintenance dose of esmolol 0.3 mL/kg/h |
| placebo group | Placebo comparator | Drug: normal salineloading dose of 0.9% sodium chloride 0.05 mL/kg and maintenance dose of 0.9% sodium chloride 0.3 mL/kg/h |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult patients
- American Society of Anesthesiologists (ASA) classification I-II
- elective inguinal hernia repair
Key exclusion criteria (13 listed)
- body mass index (BMI) >35 kg/m2
- β-blocker administration preoperatively
- systematic use of analgesic agents preoperatively
- chronic pain syndromes preoperatively
- neurological or psychiatric disease on treatment
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 |
|---|---|---|
| Esmolol HydrochlorideIn the esmolol group, patients will receive a bolus dose of esmolol followed by a continuous infusion of esmolol intraoperatively | Drug | esmolol group |
| normal salineIn the placebo group, patients will receive a bolus dose of normal saline followed by a continuous infusion of normal saline intraoperatively | Drug | placebo group |
Primary outcome
pain score 3 hours postoperatively
Time frame: 3 hours postoperatively
pain score by the use of Numeric Rating Scale (NRS) 3 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
pain score 6 hours postoperatively
Time frame: 6 hours postoperatively
pain score by the use of Numeric Rating Scale (NRS) 6 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
pain score 24 hours postoperatively
Time frame: 24 hours postoperatively
pain score by the use of Numeric Rating Scale (NRS) 24 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Background: PubMed 31104756Egan TD. Are opioids indispensable for general anaesthesia? Br J Anaesth. 2019 Jun;122(6):e127-e135. doi: 10.1016/j.bja.2019.02.018. Epub 2019 Mar 28.
- Background: PubMed 34065937Salome A, Harkouk H, Fletcher D, Martinez V. Opioid-Free Anesthesia Benefit-Risk Balance: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Clin Med. 2021 May 12;10(10):2069. doi: 10.3390/jcm10102069.
- Background: PubMed 30216240Bahr MP, Williams BA. Esmolol, Antinociception, and Its Potential Opioid-Sparing Role in Routine Anesthesia Care. Reg Anesth Pain Med. 2018 Nov;43(8):815-818. doi: 10.1097/AAP.0000000000000873.
- Background: PubMed 29028742Gelineau AM, King MR, Ladha KS, Burns SM, Houle T, Anderson TA. Intraoperative Esmolol as an Adjunct for Perioperative Opioid and Postoperative Pain Reduction: A Systematic Review, Meta-analysis, and Meta-regression. Anesth Analg. 2018 Mar;126(3):1035-1049. doi: 10.1213/ANE.0000000000002469.
- Background: PubMed 28413270Watts R, Thiruvenkatarajan V, Calvert M, Newcombe G, van Wijk RM. The effect of perioperative esmolol on early postoperative pain: A systematic review and meta-analysis. J Anaesthesiol Clin Pharmacol. 2017 Jan-Mar;33(1):28-39. doi: 10.4103/0970-9185.202182.
- Background: PubMed 29670394Andresen K, Rosenberg J. Management of chronic pain after hernia repair. J Pain Res. 2018 Apr 5;11:675-681. doi: 10.2147/JPR.S127820. eCollection 2018.
- Individual participant dataSharing planned: No
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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.
Vasiliki Samartzi contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esmolol Hydrochloride and normal saline in people with Pain, Acute and Pain, Postoperative, run by Aretaieion University Hospital at 1 site in Greece.
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 13 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 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. 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. Some participants in this study may receive a placebo. 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?
Contact Kassiani Theodoraki, PhD, DESA (+306974634162, ktheodoraki@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain score 3 hours postoperatively (time frame: 3 hours postoperatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05567822, which also lists 6 linked publications.
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 27 Oct 2022.