Tapentadol Versus Tramadol Analgesia Post Cardiac Surgery

NCT04718116 | Unknown

• 1 other identifier: 668/24.02.2020
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this randomized one-blinded study will be to evaluate the efficacy and tolerability of two different oral doses of tapentadol and compare it to tramadol (an opioid commonly used to treat post-surgical pain) in cardiac surgery patients

Conditions

Postoperative Pain; Surgery; Pain, Postoperative; Pain, Acute; Pain, Chronic; Pain, Procedural; Pain, Neuropathic; Analgesia

Keywords

tapentadol; tramadol

Outcome Measures

Primary Outcomes (7)

• change from baseline in pain score at rest

  pain score will be assessed by the use of Numeric Rating Scale (NRS) 2 hours after analgesia administration, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

  2 hours after analgesia administration

• change from baseline in pain score during coughing

  pain score will be assessed by the use of Numeric Rating Scale (NRS) 2 hours after analgesia administration, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

  2 hours after analgesia administration

• side effects

  side effects resulting from analgesic administration, yes or no

  2 hours after analgesia administration

• incidence of chronic pain 3 months after surgery

  occurrence of chronic pain at the site of the operation 3 months after surgery, with the use of the Brief Pain Inventory Questionnaire

  3 months after surgery

• incidence of chronic pain 6 months after surgery

  occurrence of chronic pain at the site of the operation 6 months after surgery, with the use of the Brief Pain Inventory Questionnaire

  6 months after surgery

• incidence of neuropathic pain 3 months after surgery

  occurrence of neuropathic pain 3 months after surgery, with the use of the Douleur Neuropathique (DN4) Questionnaire

  3 months after surgery

• incidence of neuropathic pain 6 months after surgery

  occurrence of neuropathic pain 6 months after surgery, with the use of the Douleur Neuropathique (DN4) Questionnaire

  6 months after surgery

Secondary Outcomes (2)

• hospitalization time

  postoperatively, an average period of 10 days

• satisfaction from postoperative analgesia

  72 hours postoperatively

Study Arms (3)

tapentadol 50 mg

ACTIVE COMPARATOR

tapentadol 50mg p.o 3 times daily for two days

Drug: Group tapentadol 50 mg

tapentadol 75 mg

ACTIVE COMPARATOR

tapentadol 75 mg p.o 3 times daily for two days

Drug: group tapentadol 75 mg

tramadol 100 mg

ACTIVE COMPARATOR

tramadol 100 mg p.o 3 times daily for two days

Drug: group tramadol 100 mg

Interventions

Group tapentadol 50 mg DRUG

patients in group A will receive tapentadol 50 mg p.o 3 times daily for two days

Also known as: group A

tapentadol 50 mg

group tapentadol 75 mg DRUG

patients in group B will receive tapentadol 75 mg p.o 3 times daily for two days

Also known as: group B

tapentadol 75 mg

group tramadol 100 mg DRUG

patients in group C will receive tramadol 100 mg p.o 3 times daily for two days

Also known as: group C

tramadol 100 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \<75 years old
• patients discharged from Intensive Care Unit (ICU) in less than 30 hours
• elective cardiac surgery

You may not qualify if:

• hepatic failure (increased transaminase levels
• renal failure (creatinine\> 2 mg/dL)
• ileus
• emergency surgery (hemorrhage, tamponade, aortic dissection)
• readmission in ICU
• treatment with monoaminoxidase inhibitors, selective serotonine reuptake inhibitors or antiepileptics
• age\>75 years old
• communication or language barriers
• Lack of informed consent

Sponsors & Collaborators

• Aretaieion University Hospital: lead

Study Sites (2)

Onassis Cardiac Surgery Centre

Athens, 17674, Greece

RECRUITING

Ygeia General Hospital of Athens

Athens, Greece

RECRUITING

Related Publications (9)

• Raksamani K, Wongkornrat W, Siriboon P, Pantisawat N. Pain management after cardiac surgery: are we underestimating post sternotomy pain? J Med Assoc Thai. 2013 Jul;96(7):824-8.

  PMID: 24319854 BACKGROUND

• Roediger L, Larbuisson R, Lamy M. New approaches and old controversies to postoperative pain control following cardiac surgery. Eur J Anaesthesiol. 2006 Jul;23(7):539-50. doi: 10.1017/S0265021506000548.

  PMID: 16677435 BACKGROUND

• Taillefer MC, Carrier M, Belisle S, Levesque S, Lanctot H, Boisvert AM, Choiniere M. Prevalence, characteristics, and predictors of chronic nonanginal postoperative pain after a cardiac operation: a cross-sectional study. J Thorac Cardiovasc Surg. 2006 Jun;131(6):1274-80. doi: 10.1016/j.jtcvs.2006.02.001.

  PMID: 16733157 BACKGROUND

• Gjeilo KH, Klepstad P, Wahba A, Lydersen S, Stenseth R. Chronic pain after cardiac surgery: a prospective study. Acta Anaesthesiol Scand. 2010 Jan;54(1):70-8. doi: 10.1111/j.1399-6576.2009.02097.x. Epub 2009 Aug 13.

  PMID: 19681771 BACKGROUND

• Nachiyunde B, Lam L. The efficacy of different modes of analgesia in postoperative pain management and early mobilization in postoperative cardiac surgical patients: A systematic review. Ann Card Anaesth. 2018 Oct-Dec;21(4):363-370. doi: 10.4103/aca.ACA_186_17.

  PMID: 30333328 BACKGROUND

• Tzschentke TM, Christoph T, Kogel BY. The mu-opioid receptor agonist/noradrenaline reuptake inhibition (MOR-NRI) concept in analgesia: the case of tapentadol. CNS Drugs. 2014 Apr;28(4):319-29. doi: 10.1007/s40263-014-0151-9.

  PMID: 24578192 BACKGROUND

• Langford RM, Knaggs R, Farquhar-Smith P, Dickenson AH. Is tapentadol different from classical opioids? A review of the evidence. Br J Pain. 2016 Nov;10(4):217-221. doi: 10.1177/2049463716657363. Epub 2016 Jul 25.

  PMID: 27867511 BACKGROUND

• Raffa RB, Buschmann H, Christoph T, Eichenbaum G, Englberger W, Flores CM, Hertrampf T, Kogel B, Schiene K, Strassburger W, Terlinden R, Tzschentke TM. Mechanistic and functional differentiation of tapentadol and tramadol. Expert Opin Pharmacother. 2012 Jul;13(10):1437-49. doi: 10.1517/14656566.2012.696097. Epub 2012 Jun 15.

  PMID: 22698264 BACKGROUND

• Lee YK, Ko JS, Rhim HY, Lee EJ, Karcher K, Li H, Shapiro D, Lee HS. Acute postoperative pain relief with immediate-release tapentadol: randomized, double-blind, placebo-controlled study conducted in South Korea. Curr Med Res Opin. 2014 Dec;30(12):2561-70. doi: 10.1185/03007995.2014.954665. Epub 2014 Aug 27.

  PMID: 25133962 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain; Chronic Pain; Pain, Procedural; Neuralgia; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Perceptual Disorders; Neurobehavioral Manifestations

Study Officials

• Kassiani Theodoraki, PhD, DESA

  Aretaieion University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kassiani Theodoraki, PhD, DESA

CONTACT

+306974634162; ktheodoraki@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: January 17, 2021
• First Posted: January 22, 2021
• Study Start: November 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

GR (2)