Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04718116
Other study ID # 668/24.02.2020
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2022
Est. completion date December 31, 2024

Study information

Verified date February 2023
Source Aretaieion University Hospital
Contact Kassiani Theodoraki, PhD, DESA
Phone +306974634162
Email ktheodoraki@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

Management of post-surgical pain is a daily challenge for every anaesthetist. Undertreated post-surgical pain can result in cardiovascular, pulmonary and gastrointestinal complications, as well as chronic pain and negative psychological effects. A negative impact may be seen on immune function, coagulation and wound healing. Opioids have been the cornerstone in the treatment of pain after cardiac surgery. However, opioids have a number of adverse effects such as respiratory depression, gastrointestinal alterations, dizziness, delirium, addiction. Tapentadol is a new synthetic opioid with dual mechanism of action. It acts as a mu-receptor agonist, as well as norepinephrine reuptake inhibitor. It is used to treat moderate to severe pain and is associated with fewer adverse effects compared to other opioids. 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). Patients undergoing cardiac surgery and being discharged from ICU to ward within 30 hours of surgery, will be divided into 3 groups. Group A will receive tapentadol 50mg p.o 3 times daily for two days, group B will receive tapentadol 75 mg p.o 3 times daily for two days and group C will receive tramadol 100 mg p.o 3 times daily for two days. Pain level will be assessed with Numeric Rating Scale (NRS), before drug administration and two hours after drug administration. Overall patient satisfaction will be assessed with Likert scale. Brief Pain Inventory( short form) and DN4 questionnaire will be used to detect chronic pain and neuropathic pain respectively, 3 and 6 months after surgery.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - age <75 years old - patients discharged from Intensive Care Unit (ICU) in less than 30 hours - elective cardiac surgery Exclusion Criteria: - 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

Study Design


Intervention

Drug:
Group tapentadol 50 mg
patients in group A will receive tapentadol 50 mg p.o 3 times daily for two days
group tapentadol 75 mg
patients in group B will receive tapentadol 75 mg p.o 3 times daily for two days
group tramadol 100 mg
patients in group C will receive tramadol 100 mg p.o 3 times daily for two days

Locations

Country Name City State
Greece Onassis Cardiac Surgery Centre Athens
Greece Ygeia General Hospital of Athens Athens

Sponsors (1)

Lead Sponsor Collaborator
Aretaieion University Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary side effects side effects resulting from analgesic administration, yes or no 2 hours after analgesia administration
Primary 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
Primary 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
Primary 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
Primary 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 hospitalization time duration of hospital stay after surgery in days postoperatively, an average period of 10 days
Secondary satisfaction from postoperative analgesia satisfaction from postoperative analgesia on a six-point Likert scale with 1 marked as minimal satisfaction and 6 as maximal satisfaction 72 hours postoperatively
See also
  Status Clinical Trial Phase
Recruiting NCT05583916 - Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery N/A
Completed NCT04448041 - CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
Completed NCT03213314 - HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies N/A
Enrolling by invitation NCT05534490 - Surgery and Functionality in Older Adults N/A
Recruiting NCT04792983 - Cognition and the Immunology of Postoperative Outcomes
Terminated NCT04612491 - Pre-operative Consultation on Patient Anxiety and First-time Mohs Micrographic Surgery
Recruiting NCT06397287 - PROM Project Urology
Recruiting NCT04444544 - Quality of Life and High-Risk Abdominal Cancer Surgery
Completed NCT04204785 - Noise in the OR at Induction: Patient and Anesthesiologists Perceptions N/A
Completed NCT03432429 - Real Time Tissue Characterisation Using Mass Spectrometry REI-EXCISE iKnife Study
Completed NCT04176822 - Designing Animated Movie for Preoperative Period N/A
Recruiting NCT05370404 - Prescribing vs. Recommending Over-The-Counter (PROTECT) Analgesics for Patients With Postoperative Pain: N/A
Not yet recruiting NCT05467319 - Ferric Derisomaltose/Iron Isomaltoside and Outcomes in the Recovery of Gynecologic Oncology ERAS Phase 3
Recruiting NCT04602429 - Children's Acute Surgical Abdomen Programme
Completed NCT03124901 - Accuracy of Noninvasive Pulse Oximeter Measurement of Hemoglobin for Rainbow DCI Sensor N/A
Completed NCT04595695 - The Effect of Clear Masks in Improving Patient Relationships N/A
Recruiting NCT06103136 - Maestro 1.0 Post-Market Registry
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Completed NCT04059328 - Novel Surgical Checklists for Gynecologic Laparoscopy in Haiti
Recruiting NCT03697278 - Monitoring Postoperative Patient-controlled Analgesia (PCA) N/A