Oral Use of Dexketoprofen/Tramadol for Acute Postoperative Pain in Total Hip Replacement With a Direct Anterior Approach.

NCT04178109 | Completed Phase 2

• 1 other identifier: 17200
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

Brief Summary

Pain is a global public health issue and represents the most common reason for both physician consultation and hospital admissions . When unrelieved or poorly controlled, it is associated with medical complications, poor patient satisfaction and increased risk of developing chronic pain. Dexketoprofen is a new NSAID treating acute postoperative pain and when it combined with tramadol may have a better effect. The purpose of this study is to evaluate the analgesic effect of the oral use of the combination of dexketoprofen/tramadole on the reduction of postoperative pain after total hip arthroplasty with minimal invasive anterior approach (AMIS).

Conditions

Postoperative Pain; Pain, Acute

Outcome Measures

Primary Outcomes (5)

• Pain score in 8hours

  Pain score with the visualised analogue scale in 8hours

  8 hours

• Pain score in 24hours

  Pain score with the visualised analogue scale in 24 hours

  24 hours

• Pain score in 48 hours

  Pain score with the visualised analogue scale in 48 hours

  48 hours

• Pain score in 72 hours

  Pain score with the visualised analogue scale in 72 hours

  72 hours

• Total analgesic consumption

  Total analgesic consumption as rescue analgesia the first 24 hours

  24 houra

Secondary Outcomes (1)

• Side effects

  72 hours

Study Arms (2)

Group A

ACTIVE COMPARATOR

Group A was under spinal anesthesia with a 25G cutting edge needle with levobupivacaine 10-15mg and fentanyl 10μg. Periarticular injection was done by the surgeon with a dilition of 100ml N/S 0,9% with 300mg ropivacaine and 0,5mg epinephrine. Group A was given the oral combination dexketoprofen/tramadole (25mg/75mg) 2h after surgery every 8h for 72h.

Drug: Dexketoprofen/tramadol (27mg/75mg); Drug: Ropivacaine Hydrochloride 7.5 MG/ML; Drug: Levobupivacaine Hydrochloride

Group B

PLACEBO COMPARATOR

Group B was under spinal anesthesia with a 25G cutting edge needle with levobupivacaine 10-15mg and fentanyl 10μg. Periarticular injection was done by the surgeon with a dilition of 100ml N/S 0,9% with 300mg ropivacaine and 0,5mg epinephrine. Group B received postoperative analgesia with intravenous tramadole 75mg and paracetamol 1g every 8h with the first dose beginning 2h after the end of the surgery. For 72h

Drug: Tramadol hydrochloride; Drug: Paracetamol; Drug: Ropivacaine Hydrochloride 7.5 MG/ML; Drug: Levobupivacaine Hydrochloride

Interventions

Dexketoprofen/tramadol (27mg/75mg) DRUG

Postoperatively patients in Group A received the oral combination dexketoprofen/tramadol for the treatment of acute postoperative pain the first 72h

Group A

Tramadol hydrochloride DRUG

Patients in group B received IV tramadol 75mg every 8h

Group B

Paracetamol DRUG

Patients in group B received IV paracetamol 1g every 8h

Group B

Ropivacaine Hydrochloride 7.5 MG/ML DRUG

300mg ropivacaine as periarticular injection in a dilution of 100ml n/s 0,9% was done by the orthopedic surgeon in all patients

Group A; Group B

Levobupivacaine Hydrochloride DRUG

10-15mg levobupivacaine was done subarachnoidal for spinal anesthesia

Group A; Group B

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• unilateral total hip arthroplasty with a direct anterior minimal invasive technique
• ASA score I or II
• signed written informed consent form
• days hospitalization
• years old
• primary Total hip arthroplasty

You may not qualify if:

• allergy to any given drugs
• contraindications for spinal anesthesia
• active bleeding
• renal failure ( gfr\< 90ml/h)
• hepatic failure ( abnormal sgot,sgpt,γgt)
• heart failure
• history of gastrointestinal bleeding

Sponsors & Collaborators

• KAT General Hospital: lead

Study Sites (1)

Elena Nikolakopoulou

Athens, Kifissia, 14571, Greece

Location

Related Publications (1)

• Macheras GA, Tzefronis D, Argyrou C, Nikolakopoulou E, Galvez Miravete A, Karachalios TS. Pain management after total hip arthroplasty: comparative study of analgesic efficacy and tolerability between oral tramadol/dexketoprofen and injectable paracetamol + tramadol. Hip Int. 2024 May;34(3):304-310. doi: 10.1177/11207000231219797. Epub 2024 Jan 10.

  PMID: 38204364 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain

Interventions

dexketoprofen trometamol; Tramadol; Acetaminophen; Ropivacaine; Levobupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Acetanilides; Anilides; Amides; Aniline Compounds; Bupivacaine

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 24, 2019
• First Posted: November 26, 2019
• Study Start: January 10, 2019
• Primary Completion: November 10, 2019
• Study Completion: November 20, 2019
• Last Updated: November 26, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share

Locations

GR (1)