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

Phase 2

Completed

• Conditions: Postoperative Pain; Pain, Acute
• Interventions: Drug: Dexketoprofen/tramadol (27mg/75mg); Drug: Tramadol hydrochloride; Drug: Ropivacaine Hydrochloride 7.5 MG/ML; Drug: Paracetamol; Drug: Levobupivacaine Hydrochloride

• Registration Number: NCT04178109
• Lead Sponsor: KAT General Hospital

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-10
• Status Verified: 2019-11
• Primary Completion: 2019-11-10
• Study Completion: 2019-11-20
• Study First Submitted: 2019-11-24
• Study First Submitted QC: 2019-11-24
• Last Update Submitted: 2019-11-24
• Study First Posted: 2019-11-26
• Last Update Posted: 2019-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 226

Inclusion Criteria

• unilateral total hip arthroplasty with a direct anterior minimal invasive technique
• ASA score I or II
• signed written informed consent form
• 3 days hospitalization
• 45-80 years old
• primary Total hip arthroplasty

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Dexketoprofen/tramadol (27mg/75mg)	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.
Group A	Ropivacaine Hydrochloride 7.5 MG/ML	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.
Group A	Levobupivacaine Hydrochloride	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.
Group B	Ropivacaine Hydrochloride 7.5 MG/ML	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
Group B	Levobupivacaine Hydrochloride	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
Group B	Paracetamol	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
Group B	Tramadol hydrochloride	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

Primary Outcome Measures

Name	Time	Method
Pain score in 72 hours	72 hours	Pain score with the visualised analogue scale in 72 hours
Pain score in 8hours	8 hours	Pain score with the visualised analogue scale in 8hours
Pain score in 24hours	24 hours	Pain score with the visualised analogue scale in 24 hours
Pain score in 48 hours	48 hours	Pain score with the visualised analogue scale in 48 hours
Total analgesic consumption	24 houra	Total analgesic consumption as rescue analgesia the first 24 hours

Secondary Outcome Measures

Name	Time	Method
Side effects	72 hours	All the side effects of the drug the first 72 hours

Trial Locations

Locations (1)

Elena Nikolakopoulou; 🇬🇷 Athens, Kifissia, Greece