NCT03498898

Brief Summary

This study is designed to discover if chronic use of Beta adrenergic receptor blockers affects pain sensation during and after an elective procedure of hip or knee replacement. The study's population will be divided to four groups: Group A- chronic use of Beta adrenergic receptor blockers undergoing total hip replacement, Group B- no use of Beta adrenergic receptor blockers undergoing total hip replacement, Group C- chronic use of Beta adrenergic receptor blockers undergoing total knee replacement and Group D- no use of Beta adrenergic receptor blockers undergoing total knee replacement. Each patient will be anesthetized using the same anesthesia protocol with pain assessment done by the ANI device intra operatively and by NRS score postoperatively.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 17, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

August 16, 2018

Status Verified

April 1, 2018

Enrollment Period

1.3 years

First QC Date

April 8, 2018

Last Update Submit

August 14, 2018

Conditions

Nociceptive Pain

Keywords

Beta adrenergic receptor blockersAnalgesia nociceptive indexTotal hip replacementTotal knee replacement

Outcome Measures

Primary Outcomes (1)

  • Fentanyl consumption during surgery.

    Measuring the effect of chronic use of Beta adrenergic receptor blockers on the amount of analgesia (Fentanyl).

    Intra operative (anaesthesia start until anaesthesia end).

Secondary Outcomes (3)

  • Post operative Morphine consumption.

    Immediate post operative time (from admission to release from PACU).

  • Post operative non opioid analgesia consumption.

    Immediate post operative time (from admission to release from PACU).

  • Post operative pain (NRS score).

    15 minutes after admission to PACU.

Study Arms (4)

Group A

ACTIVE COMPARATOR

American Society of Anesthesiologists (ASA) Score 2-3 with chronic use of Beta adrenergic receptor blockers planned to undergo total hip replacement

Other: Chronic use of Beta adrenergic receptor blocker

Group B

NO INTERVENTION

American Society of Anesthesiologists (ASA) Score 2-3 with no chronic use of Beta adrenergic receptor blockers planned to undergo total hip replacement

Group C

ACTIVE COMPARATOR

American Society of Anesthesiologists (ASA) Score 2-3 with chronic use of Beta adrenergic receptor blockers planned to undergo total knee replacement.

Other: Chronic use of Beta adrenergic receptor blocker

Group D

NO INTERVENTION

American Society of Anesthesiologists (ASA) Score 2-3 with no chronic use of Beta adrenergic receptor blockers planned to undergo total knee replacement

Interventions

Chronic use of Beta adrenergic receptor blockerOTHER

Chronic use of Beta adrenergic receptor blocker

Group AGroup C

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Candidates for an elective hip replacement.

You may not qualify if:

  • Patients with no sinus rhythm.
  • Patients with an internal cardiac device / cardiac pacemaker.
  • The use of Anti muscarinic, alpha adrenergic receptor blockers or anti arhythmic medications.
  • Chronic use of Opioids (defined as 20 mg or more of Oxycodone per day for a period of 6 weeks or more).
  • BMI\> 40.
  • Sensitivity to one of the following drugs: Propofol, Fentanyl, Rocuronium, Isoflurane, Morphine, Acetaminophen, Ondansetron.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel-Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

RECRUITING

Related Publications (13)

  • White PF. What are the advantages of non-opioid analgesic techniques in the management of acute and chronic pain? Expert Opin Pharmacother. 2017 Mar;18(4):329-333. doi: 10.1080/14656566.2017.1289176. Epub 2017 Feb 20. No abstract available.

    PMID: 28132576BACKGROUND

  • Chia YY, Chan MH, Ko NH, Liu K. Role of beta-blockade in anaesthesia and postoperative pain management after hysterectomy. Br J Anaesth. 2004 Dec;93(6):799-805. doi: 10.1093/bja/aeh268. Epub 2004 Sep 17.

    PMID: 15377583BACKGROUND

  • Collard V, Mistraletti G, Taqi A, Asenjo JF, Feldman LS, Fried GM, Carli F. Intraoperative esmolol infusion in the absence of opioids spares postoperative fentanyl in patients undergoing ambulatory laparoscopic cholecystectomy. Anesth Analg. 2007 Nov;105(5):1255-62, table of contents. doi: 10.1213/01.ane.0000282822.07437.02.

    PMID: 17959952BACKGROUND

  • Lopez-Alvarez S, Mayo-Moldes M, Zaballos M, Iglesias BG, Blanco-Davila R. Esmolol versus ketamine-remifentanil combination for early postoperative analgesia after laparoscopic cholecystectomy: a randomized controlled trial. Can J Anaesth. 2012 May;59(5):442-8. doi: 10.1007/s12630-012-9684-x. Epub 2012 Mar 2.

    PMID: 22383085BACKGROUND

  • Harkanen L, Halonen J, Selander T, Kokki H. Beta-adrenergic antagonists during general anesthesia reduced postoperative pain: a systematic review and a meta-analysis of randomized controlled trials. J Anesth. 2015 Dec;29(6):934-43. doi: 10.1007/s00540-015-2041-9. Epub 2015 Jul 10.

    PMID: 26160590BACKGROUND

  • Funcke S, Sauerlaender S, Pinnschmidt HO, Saugel B, Bremer K, Reuter DA, Nitzschke R. Validation of Innovative Techniques for Monitoring Nociception during General Anesthesia: A Clinical Study Using Tetanic and Intracutaneous Electrical Stimulation. Anesthesiology. 2017 Aug;127(2):272-283. doi: 10.1097/ALN.0000000000001670.

    PMID: 28489614BACKGROUND

  • De Jonckheere J, Logier R, Jounwaz R, Vidal R, Jeanne M. From pain to stress evaluation using heart rate variability analysis: development of an evaluation platform. Annu Int Conf IEEE Eng Med Biol Soc. 2010;2010:3852-5. doi: 10.1109/IEMBS.2010.5627661.

    PMID: 21097068BACKGROUND

  • Logier R, Jeanne M, De Jonckheere J, Dassonneville A, Delecroix M, Tavernier B. PhysioDoloris: a monitoring device for analgesia / nociception balance evaluation using heart rate variability analysis. Annu Int Conf IEEE Eng Med Biol Soc. 2010;2010:1194-7. doi: 10.1109/IEMBS.2010.5625971.

    PMID: 21095676BACKGROUND

  • Upton HD, Ludbrook GL, Wing A, Sleigh JW. Intraoperative "Analgesia Nociception Index"-Guided Fentanyl Administration During Sevoflurane Anesthesia in Lumbar Discectomy and Laminectomy: A Randomized Clinical Trial. Anesth Analg. 2017 Jul;125(1):81-90. doi: 10.1213/ANE.0000000000001984.

    PMID: 28598927BACKGROUND

  • Dundar N, Kus A, Gurkan Y, Toker K, Solak M. Analgesia nociception index (ani) monitoring in patients with thoracic paravertebral block: a randomized controlled study. J Clin Monit Comput. 2018 Jun;32(3):481-486. doi: 10.1007/s10877-017-0036-9. Epub 2017 Jun 19.

    PMID: 28631050BACKGROUND

  • Jensen MP, McFarland CA. Increasing the reliability and validity of pain intensity measurement in chronic pain patients. Pain. 1993 Nov;55(2):195-203. doi: 10.1016/0304-3959(93)90148-I.

    PMID: 8309709BACKGROUND

  • Andersson V, Bergman S, Henoch I, Ene KW, Otterstrom-Rydberg E, Simonsson H, Ahlberg K. Pain and pain management in hospitalized patients before and after an intervention. Scand J Pain. 2017 Apr;15:22-29. doi: 10.1016/j.sjpain.2016.11.006. Epub 2016 Dec 9.

    PMID: 28850341BACKGROUND

  • Gruenewald M, Ilies C, Herz J, Schoenherr T, Fudickar A, Hocker J, Bein B. Influence of nociceptive stimulation on analgesia nociception index (ANI) during propofol-remifentanil anaesthesia. Br J Anaesth. 2013 Jun;110(6):1024-30. doi: 10.1093/bja/aet019. Epub 2013 Mar 6.

    PMID: 23471754BACKGROUND

MeSH Terms

Conditions

Nociceptive Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Idit Matot, MD, PhD

    Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Idit Matot, MD, PhD

CONTACT

97236974758iditm@tlvmc.gov.il

Miri Davidovich

CONTACT

97236974758mirid@tlvmc.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2018

First Posted

April 17, 2018

Study Start

June 1, 2018

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

August 16, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)