PainNCT01782898
The Effect of Intraoperative Esmolol to Improve Postoperative Quality of Recovery and Pain After Ambulatory Surgery
A study testing Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min in people with Pain, run by Northwestern University at 1 site in United States.
Trial summary
Seventy percent of surgeries performed in the United States are done in an outpatient setting.Pain Control after ambulatory surgery is very challenging because patients do not have access to fast and potent intravenous medications Pain after ambulatory surgery is poorly controlled in the United States with up to… Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Pain
- What is being tested?
- Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min
- 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 siteUnited States
- Study dates
- Jan 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients Undergoing outpatient hysteroscopic myomectomy surgery ASA PS I and II Age between 18 and 64 years Fluent in English
Who cannot join
- History of allergy to beta-blocker History of chronic opioid use Pregnant patients BMI greater than 35 History of EKG abnormalities or cardiac arrhythmias Beta-blocker medication usage.
- Dropout criteria: Patient or surgeon request, Conversion of the surgery from laparoscopic to open.
Trial locations and contacts
1 site in 1 country.
About this study
Seventy percent of surgeries performed in the United States are done in an outpatient setting.Pain Control after ambulatory surgery is very challenging because patients do not have access to fast and potent intravenous medications Pain after ambulatory surgery is poorly controlled in the United States with up to seventy five percent of patients having moderate to severe pain after ambulatory procedures. Postoperative pain have been associated with serious morbidity, including myocardial infarction and pulmonary embolism.
The use of intraoperative opioids can result in an exaggerated response to pain (hyperalgesia) and contribute to an exacerbation of pain after surgical procedures.Opioids are commonly given intraoperative, not in response to pain, but in response to hyperdynamic cardiovascular states. Esmolol is a short acting beta 1 antagonist that can be used to treat/prevent hyperdynamic states during surgery. More importantly, esmolol has been shown to have central antihyperalgesic effects that might contribute to a reduction in postoperative pain. It is therefore conceivable that the use of intraoperative esmolol instead of opioids to avoid hyperdynamic states during surgery can result in lower postoperative pain. Since postoperative pain can substantially affect postoperative quality of recovery, it is also conceivable that the use of intraoperative esmolol might result in an improved postoperative quality of recovery to surgical patients.
Read more
The main objective of the current study is to examine the effect of intraoperative esmolol on postoperative quality of recovery. A secondary objective is to examine the effect of esmolol on postoperative pain.
Significance: Postoperative pain after ambulatory surgery has been shown to be poorly managed in The United States. The goal of this study is to investigate if a change in the intraoperative pharmacologic management of patients undergoing ambulatory surgery can improve their postoperative quality of recovery and pain.
The research question is; does the use of intraoperative esmolol improve postoperative quality of recovery after ambulatory surgery? Does the use of intraoperative esmolol improve postoperative pain after ambulatory surgery?
The hypotheses of this study is; does the use of intraoperative esmolol improves postoperative quality of recovery after ambulatory surgery. The use of intraoperative esmolol reduces postoperative pain after ambulatory surgery.
Read the detailed description
We propose a randomized double blinded placebo controlled clinical trial. Healthy females undergoing outpatient surgery will be recruited . Before surgery patients will be tested for pain sensitivity and threshold using a Pathway Pain \& sensory evaluation system (Medoc, Dunham, NC).Subjects will randomized using a computer generated table of random numbers to two groups: Active (Esmolol 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min titrated to keep heart rate between 50 and 70 BPM) or control (same volume of normal saline).The infusion will be discontinued at the end of the surgical procedure. Subjects will receive a standard anesthetic regimen: Induction (2 mg versed, 1-2mg /kg propofol and 0.6mg/kg of rocuronium), maintenance (Sevoflurane titrated to a Bispectral index between 40-60 and fentanyl 50 mcg q 10 minutes to maintain blood pressure within 20% of baseline value. Patients will receive at the end of surgery ondansetron 4 mg IV to prevent nausea and/or vomiting. The postoperative analgesic regimen will also be standardized with hydromorphone 0.4 mg every 15 minutes to treat pain greater than 4/10 (scale where 0 means no pain and 10 means the worst possible pain) and hydrocodone 10 mg/acetaminophen 325 for pain control after discharge. Patients will receive ephedrine 5 mg q5minutes if blood pressure is lower than 40% baseline or if the heart rate is less than 40 beats per minute. Before hospital discharge patients will again be tested for pain sensitivity and threshold using a Pathway Pain \& sensory evaluation system (Medoc, Dunham, NC).
The primary outcome will be a validated instrument to measure postoperative quality of recovery (QoR-40) that will be administered to patients by an investigator unaware of group allocation at 24 hours after the surgery.Other outcomes to be evaluated include; postoperative pain sensitivity and threshold, postoperative opioid consumption, postoperative pain, time to meet discharge criteria using a validated instrument (PADDS).
- Conditions
- Pain
- Being tested
- Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min, Placebo Comparator: .9 normal saline
- Keywords
- Anesthesia, MEDOC neuro sensory analyzer, Pain, Quality of recovery
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/minDrug
Also called Esmolol
Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min
Placebo Comparator: .9 normal salineDrug
Also called Normal Saline
Placebo Comparator: Placebo .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,
| Study group | Role | What they receive |
|---|---|---|
| Esmolol | Active comparator | Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min Receives: Drug: Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min |
| .9 normal saline | Placebo comparator | .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered, Receives: Drug: Placebo Comparator: .9 normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qor-40 at 24 Hours Postoperative
Quality of recovery questionnaire score at 24 hours after surgery. Quality of recovery score 24 hours after the surgical procedure.Score of 40 is poor recovery and a score of 200 is good recovery.
Time frame for this evaluation is 24 hours after the surgical procedure
Measured: 24 hours
Secondary outcomes (2)
Postoperative Opioid Consumption
The total amount of opioid consumed by subject at 24 hours after surgery measured in IV morphine equivalents.
Measured: 24 hours
Post Operative Pain Reported by the Subject.
Post operative pain reported by the subject as determined as area under the numeric rating scale for pain versus time curve in the post anesthesia care unit ( score*min).Numeric rating scale for pain on a scale of 0-10 (0 is no pain and 10 is high pain) versus time curve in the post anesthesia care unit ( score * min). A higher value indicates more pain over 24 hours.The range is 0 pain to x time in minutes x hour ( 60-1440 minutes) . The pain scores were collected at 15 minute intervals from the time of admission to the PACU to 24 hours after the surgical procedure. The area under the NRS pain scale versus time curve was calculated using the trapezoidal method as an indicator of pain burden during early recovery (Graph Pad Prism ver 5.03, Graph Pad Software INC.
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Northwestern 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gildasio De Oliveira, Northwestern University
- Investigators
- Gildasio De Oliveira, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01782898
- Sponsor's protocol ID
- STU00066623
- Status last verified
- Oct 2016
- First submitted
- 31 Jan 2013
- Last updated
- 11 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intraoperative Esmolol to Improve Postoperative Quality of Recovery and Pain After Ambulatory Surgery
- ClinicalTrials.gov ID
- NCT01782898
- Acronym / sponsor ID
- STU00066623
- Conditions
- Pain
- Keywords
- Anesthesia, MEDOC neuro sensory analyzer, Pain, Quality of recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 4 Feb 2013 (estimated)
- Results
- Posted 4 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Seventy percent of surgeries performed in the United States are done in an outpatient setting.Pain Control after ambulatory surgery is very challenging because patients do not have access to fast and potent intravenous medications Pain after ambulatory surgery is poorly controlled in the United States with up to seventy five percent of patients having moderate to severe pain after ambulatory procedures. Postoperative pain have been associated with serious morbidity, including myocardial infarction and pulmonary embolism.
The use of intraoperative opioids can result in an exaggerated response to pain (hyperalgesia) and contribute to an exacerbation of pain after surgical procedures.Opioids are commonly given intraoperative, not in response to pain, but in response to hyperdynamic cardiovascular states. Esmolol is a short acting beta 1 antagonist that can be used to treat/prevent hyperdynamic states during surgery. More importantly, esmolol has been shown to have central antihyperalgesic effects that might contribute to a reduction in postoperative pain. It is therefore conceivable that the use of intraoperative esmolol instead of opioids to avoid hyperdynamic states during surgery can result in lower postoperative pain. Since postoperative pain can substantially affect postoperative quality of recovery, it is also conceivable that the use of intraoperative esmolol might result in an improved postoperative quality of recovery to surgical patients.
The main objective of the current study is to examine the effect of intraoperative esmolol on postoperative quality of recovery. A secondary objective is to examine the effect of esmolol on postoperative pain.
Significance: Postoperative pain after ambulatory surgery has been shown to be poorly managed in The United States. The goal of this study is to investigate if a change in the intraoperative pharmacologic management of patients undergoing ambulatory surgery can improve their postoperative quality of recovery and pain.
The research question is; does the use of intraoperative esmolol improve postoperative quality of recovery after ambulatory surgery? Does the use of intraoperative esmolol improve postoperative pain after ambulatory surgery?
The hypotheses of this study is; does the use of intraoperative esmolol improves postoperative quality of recovery after ambulatory surgery. The use of intraoperative esmolol reduces postoperative pain after ambulatory surgery.
Detailed description
We propose a randomized double blinded placebo controlled clinical trial. Healthy females undergoing outpatient surgery will be recruited . Before surgery patients will be tested for pain sensitivity and threshold using a Pathway Pain \& sensory evaluation system (Medoc, Dunham, NC).Subjects will randomized using a computer generated table of random numbers to two groups: Active (Esmolol 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min titrated to keep heart rate between 50 and 70 BPM) or control (same volume of normal saline).The infusion will be discontinued at the end of the surgical procedure. Subjects will receive a standard anesthetic regimen: Induction (2 mg versed, 1-2mg /kg propofol and 0.6mg/kg of rocuronium), maintenance (Sevoflurane titrated to a Bispectral index between 40-60 and fentanyl 50 mcg q 10 minutes to maintain blood pressure within 20% of baseline value. Patients will receive at the end of surgery ondansetron 4 mg IV to prevent nausea and/or vomiting. The postoperative analgesic regimen will also be standardized with hydromorphone 0.4 mg every 15 minutes to treat pain greater than 4/10 (scale where 0 means no pain and 10 means the worst possible pain) and hydrocodone 10 mg/acetaminophen 325 for pain control after discharge. Patients will receive ephedrine 5 mg q5minutes if blood pressure is lower than 40% baseline or if the heart rate is less than 40 beats per minute. Before hospital discharge patients will again be tested for pain sensitivity and threshold using a Pathway Pain \& sensory evaluation system (Medoc, Dunham, NC).
The primary outcome will be a validated instrument to measure postoperative quality of recovery (QoR-40) that will be administered to patients by an investigator unaware of group allocation at 24 hours after the surgery.Other outcomes to be evaluated include; postoperative pain sensitivity and threshold, postoperative opioid consumption, postoperative pain, time to meet discharge criteria using a validated instrument (PADDS).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Esmolol | Active comparator | Drug: Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/minEsmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min |
| .9 normal saline | Placebo comparator | Drug: Placebo Comparator: .9 normal saline.9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered, |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Female patients Undergoing outpatient hysteroscopic myomectomy surgery ASA PS I and II Age between 18 and 64 years Fluent in English
Key exclusion criteria (2 listed)
- History of allergy to beta-blocker History of chronic opioid use Pregnant patients BMI greater than 35 History of EKG abnormalities or cardiac arrhythmias Beta-blocker medication usage.
- Dropout criteria: Patient or surgeon request, Conversion of the surgery from laparoscopic to open.
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 administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/minAlso: EsmololEsmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min | Drug | Esmolol |
| Placebo Comparator: .9 normal salineAlso: Normal SalinePlacebo Comparator: Placebo .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered, | Drug | .9 normal saline |
Primary outcome
Qor-40 at 24 Hours Postoperative
Time frame: 24 hours
Quality of recovery questionnaire score at 24 hours after surgery. Quality of recovery score 24 hours after the surgical procedure.Score of 40 is poor recovery and a score of 200 is good recovery. Time frame for this evaluation is 24 hours after the surgical procedure
2 secondary outcomes
Postoperative Opioid Consumption
Time frame: 24 hours
Post Operative Pain Reported by the Subject.
Time frame: 24 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Gildasio De Oliveira, MD principal investigator
Northwestern University
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 administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min in people with Pain, run by Northwestern University at 1 site in United States.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 11 Nov 2016. 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 United States. 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?
Yes. Results are posted in the registry (first posted 4 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Qor-40 at 24 Hours Postoperative (time frame: 24 hours). 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 11 Nov 2016.