Pain, PostoperativePhase 4NCT05924412

Parecoxib in Total Knee Arthroplasty

A Phase 4 study testing Intravenous study drug and Intravenous saline solution in people with Pain, Postoperative and Pain, Acute, run by University of Chile at 1 site in Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Pain, Postoperative, Pain, Acute, Analgesia
What is being tested?: Intravenous study drug and Intravenous saline solution
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteChile
Study dates: 6 Jul 2023to 1 Sep 2024
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

ASA I - III BMI 20 - 35 (kg/m2)

Who cannot join

Adults who are not capable of giving their own consent
Pre-existing neuropathy (assessed in the history and physical examination)
Coagulation disturbance (assessed on history and physical examination, if clinically necessary, by blood test, i.e. platelets ≤ 100,000, international normalized ratio ≥ 1.4 or prothrombin time ≥ 50)
Renal failure (assessed by history and physical examination, if considered clinically necessary, by blood test, i.e. creatinine ≥ 1.04 mg/dl)
Hepatic impairment (assessed by history and physical examination, if considered clinically necessary, by blood tests, i.e. transaminases (GGT ≥ 50 u/lt)
Allergy to local anesthetics, morphine, paracetamol, ketorolac or parecoxib

Show all 11Show fewer

Pregnancy
Chronic pain syndromes that require the use of opioids at home
Known history of sulfa allergy
History of ischemic heart disease
History of chronic gastritis or peptic ulcer

Trial locations and contacts

1 site in 1 country.

Chile1 site

Hospital Clinico Universidad de Chile
Santiago, Metropolitan, 8380420

Other trials in Chile

About this study

Official title: A Randomized Comparison Between Parecoxib and Placebo Added to a Standard Perioperative Analgesic Protocol for Total Knee Arthroplasty

Early mobilization and rehabilitation can be difficult after total knee arthroplasty (TKA) due to a high incidence of moderate to severe postoperative pain. Non-steroidal anti-inflammatory drugs (NSAIDs) are important to multimodal analgesic protocols. Parecoxib is an NSAID that selectively inhibits the enzyme cyclooxygenase-2 (COX-2). Clinical trials have shown that it does not alter platelet function or gastric mucosa. A recent study, after comparing ketorolac and parecoxib used at the same time in infiltration and systemically, found no differences in perioperative analgesia with a tendency to less bleeding in the parecoxib group. This randomized study will compare the effectiveness of adding a COX-2 inhibitor in the pain management of patients undergoing TKA as part of a multimodal analgesia regimen. The morphine consumption was selected as the primary outcome. The study hypothesis is that patients receiving parecoxib would have a lower opioid consumption.

Conditions: Pain, Postoperative, Pain, Acute, Analgesia, Analgesic Nephropathy, Analgesic Adverse Reaction, Knee Osteoarthritis
Being tested: Intravenous study drug, Intravenous saline solution
Medical subject headings: Pain, Postoperative, Acute Pain, Agnosia, Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intravenous study drugDrug
40mg parecoxib will be administered intravenously after general anesthesia induction and before tourniquet inflation and surgical incisión
Intravenous saline solutionOther
Saline solution (same volume as the study drug) will be administered intravenously after general anesthesia induction and before tourniquet inflation and surgical incision

Study groups in NCT05924412
Study group	Role	What they receive
Parecoxib	Experimental	This arm will receive intravenous parecoxib in the intraoperative period. Receives: Drug: Intravenous study drug
Placebo	Placebo comparator	This arm will receive a placebo intravenous injection containing saline solution in the same volume as the intervention group Receives: Other: Intravenous saline solution

What is being measured

The primary outcome is the main question the study is designed to answer.

Morphine consumption
Morphine consumed postoperatively during the first 24 hrs utilizing a patient-controlled analgesia device programmed 1mg/ml morphine solution, no infusion, 1ml dose, 8 minutes lockout.
Measured: 24 hours

Secondary outcomes (29)

Basal quadriceps strength in the operative side
Leg extension strength measured with a handheld dynamometer
Measured: 1 hour before surgery
Basal level of pain during leg extension in the operative side
Pain level measured with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)
Measured: 1 hour before surgery
Basal plasmatic creatinine
Plasmatic creatinine level measured in mg/dL from a blood sample
Measured: 1 hour before surgery
Nerve block performance time
Time elapsed between skin disinfection and the end of local anesthetic injection in femoral triangle and posterior capsule blocks.
Measured: 5 minutes after anesthesia induction (before surgical incision)
Incidence of Block complications
Report of vascular puncture, hematoma, local anesthetic systemic toxicity symptoms
Measured: 5 minutes after anesthesia induction and before surgical incision
Time to first morphine dose request
Time in minutes between arrival to post anesthesia care unit arrival and first request of morphine with the patient controlled analgesia device
Measured: 24 hours
Morphine consumption during first 48 hours
Morphine consumed postoperatively during the first 48 hrs utilizing a patient-controlled analgesia device programmed 0.01mg/Kg/ml morphine solution, no infusion, 1ml dose, 8 minutes lockout.
Measured: 48 hours
Incidence of opioid related side effects
Report of nausea, vomitus, pruritus, urinary retention, respiratory depression
Measured: 48 hours
Incidence of NSAIDs related clinical side effects
Report of allergic reactions, pyrosis, evident gastrointestinal bleeding, hematoma
Measured: 48 hours
Postoperative static pain level at 3 hours
Pain level measured at rest with an 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)
Measured: 3 hours
Postoperative dynamic pain level at 3 hours
Pain level measured during leg extension with an 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)
Measured: 3 hours
Postoperative static pain level at 6 hours
Pain level measured at rest with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)
Measured: 6 hours
Postoperative dynamic pain level at 6 hours
Pain level measured during leg extension with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)
Measured: 6 hours
Postoperative static pain level at 12 hours
Pain level measured at rest with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)
Measured: 12 hours
Postoperative dynamic pain level at 12 hours
Pain level measured during leg extension with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)
Measured: 12 hours
Postoperative static pain level at 24 hours
Pain level measured at rest with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)
Measured: 24 hours
Postoperative dynamic pain level at 24 hours
Pain level measured during leg extension with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)
Measured: 24 hours
Postoperative static pain level at 48 hours
Pain level measured at rest with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)
Measured: 48 hours
Postoperative dynamic pain level at 48 hours
Pain level measured during leg extension with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)
Measured: 48 hours
Medial malleolus sensory block level
0 to 2 points for Sensory block to cold and touch in the medial malleolus. 0 point= can feel cold and touch; 1= can feel touch but not cold; 2= cannot feel cold or touch
Measured: 3 hours
Lateral malleolus sensory block level
0 to 2 points for Sensory block to cold and touch in the medial malleolus. 0 point= can feel cold and touch; 1= can feel touch but not cold; 2= cannot feel cold or touch
Measured: 3hours
Medial malleolus sensory block level
0 to 2 points for Sensory block to cold and touch in the medial malleolus. 0 point= can feel cold and touch; 1= can feel touch but not cold; 2= cannot feel cold or touch
Measured: 24 hours
Lateral malleolus sensory block level
0 to 2 points for Sensory block to cold and touch in the medial malleolus. 0 point= can feel cold and touch; 1= can feel touch but not cold; 2= cannot feel cold or touch
Measured: 24 hours
Postoperative quadriceps strength
Leg extension strength measured with a handheld dynamometer
Measured: 3 hours
Postoperative quadriceps strength
Leg extension strength measured with a handheld dynamometer
Measured: 24 hours
Incidence of restriction to perform physiotherapy
Inability to perform physiotherapy secondary to pain or motor blockade
Measured: 6 hours
Incidence of restriction to perform physiotherapy
Inability to perform physiotherapy secondary to pain or motor blockade
Measured: 24 hours
Incidence of restriction to perform physiotherapy
Inability to perform physiotherapy secondary to pain or motor blockade
Measured: 48 hours
Postoperative plasmatic creatinine level
Plasmatic creatinine level measured in mg/dL from a blood sample
Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jul 20231 Sep 2024

First posted29 Jun 2023
Study start6 Jul 2023
Primary completion1 Sep 2024
Study completion1 Sep 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized controlled trial
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05924412
Sponsor's protocol ID: OAIC1308/22
Status last verified: May 2025
First submitted: 8 Jun 2023
Last updated: 15 May 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: deidentified data under reasonable request

Publications

Aso K, Izumi M, Sugimura N, Okanoue Y, Kamimoto Y, Yokoyama M, Ikeuchi M. Additional benefit of local infiltration of analgesia to femoral nerve block in total knee arthroplasty: double-blind randomized control study. Knee Surg Sports Traumatol Arthrosc. 2019 Jul;27(7):2368-2374. doi: 10.1007/s00167-018-5322-7. Epub 2018 Dec 8.
PubMed 30536047
Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.
PubMed 26827847
Bai JW, An D, Perlas A, Chan V. Adjuncts to local anesthetic wound infiltration for postoperative analgesia: a systematic review. Reg Anesth Pain Med. 2020 Aug;45(8):645-655. doi: 10.1136/rapm-2020-101593. Epub 2020 May 30.
PubMed 32474417
Andersen LO, Kehlet H. Analgesic efficacy of local infiltration analgesia in hip and knee arthroplasty: a systematic review. Br J Anaesth. 2014 Sep;113(3):360-74. doi: 10.1093/bja/aeu155. Epub 2014 Jun 17.
PubMed 24939863
Hubbard RC, Naumann TM, Traylor L, Dhadda S. Parecoxib sodium has opioid-sparing effects in patients undergoing total knee arthroplasty under spinal anaesthesia. Br J Anaesth. 2003 Feb;90(2):166-72. doi: 10.1093/bja/aeg038.
PubMed 12538372
Harris SI, Kuss M, Hubbard RC, Goldstein JL. Upper gastrointestinal safety evaluation of parecoxib sodium, a new parenteral cyclooxygenase-2-specific inhibitor, compared with ketorolac, naproxen, and placebo. Clin Ther. 2001 Sep;23(9):1422-8. doi: 10.1016/s0149-2918(01)80117-x.
PubMed 11589257
Stoltz RR, Harris SI, Kuss ME, LeComte D, Talwalker S, Dhadda S, Hubbard RC. Upper GI mucosal effects of parecoxib sodium in healthy elderly subjects. Am J Gastroenterol. 2002 Jan;97(1):65-71. doi: 10.1111/j.1572-0241.2002.05265.x.
PubMed 11808971
Seangleulur A, Vanasbodeekul P, Prapaitrakool S, Worathongchai S, Anothaisintawee T, McEvoy M, Vendittoli PA, Attia J, Thakkinstian A. The efficacy of local infiltration analgesia in the early postoperative period after total knee arthroplasty: A systematic review and meta-analysis. Eur J Anaesthesiol. 2016 Nov;33(11):816-831. doi: 10.1097/EJA.0000000000000516.
PubMed 27428259
Affas F, Eksborg S, Wretenberg P, Olofsson C, Stephanson N, Stiller CO. Plasma concentration of ketorolac after local infiltration analgesia in hip arthroplasty. Acta Anaesthesiol Scand. 2014 Oct;58(9):1140-5. doi: 10.1111/aas.12371. Epub 2014 Jul 31.
PubMed 25078268
Laoruengthana A, Rattanaprichavej P, Reosanguanwong K, Chinwatanawongwan B, Chompoonutprapa P, Pongpirul K. A randomized controlled trial comparing the efficacies of ketorolac and parecoxib for early pain management after total knee arthroplasty. Knee. 2020 Dec;27(6):1708-1714. doi: 10.1016/j.knee.2020.10.005. Epub 2020 Nov 13.
PubMed 33197808
Chan E, Howle R, Onwochei D, Desai N. Infiltration between the popliteal artery and the capsule of the knee (IPACK) block in knee surgery: a narrative review. Reg Anesth Pain Med. 2021 Sep;46(9):784-805. doi: 10.1136/rapm-2021-102681. Epub 2021 May 14.
PubMed 33990439
Summers S, Mohile N, McNamara C, Osman B, Gebhard R, Hernandez VH. Analgesia in Total Knee Arthroplasty: Current Pain Control Modalities and Outcomes. J Bone Joint Surg Am. 2020 Apr 15;102(8):719-727. doi: 10.2106/JBJS.19.01035. No abstract available.
PubMed 31985507
Sankineani SR, Reddy ARC, Eachempati KK, Jangale A, Gurava Reddy AV. Comparison of adductor canal block and IPACK block (interspace between the popliteal artery and the capsule of the posterior knee) with adductor canal block alone after total knee arthroplasty: a prospective control trial on pain and knee function in immediate postoperative period. Eur J Orthop Surg Traumatol. 2018 Oct;28(7):1391-1395. doi: 10.1007/s00590-018-2218-7. Epub 2018 May 2.
PubMed 29721648

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Comparison Between Parecoxib and Placebo Added to a Standard Perioperative Analgesic Protocol for Total Knee Arthroplasty
ClinicalTrials.gov ID: NCT05924412
Acronym / sponsor ID: OAIC1308/22
Conditions: Pain, Postoperative, Pain, Acute, Analgesia, Analgesic Nephropathy, Analgesic Adverse Reaction, Knee Osteoarthritis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: University of ChileUniversity, hospital or other
Study start: 6 Jul 2023 (actual)
Primary completion: 1 Sep 2024 (actual)
Study completion: 1 Sep 2024 (actual)
First posted: 29 Jun 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Randomized controlled trial

Arm	Type	Receives
Parecoxib	Experimental	Drug: Intravenous study drugThis arm will receive intravenous parecoxib in the intraoperative period.
Placebo	Placebo comparator	Other: Intravenous saline solutionThis arm will receive a placebo intravenous injection containing saline solution in the same volume as the intervention group

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

ASA I - III BMI 20 - 35 (kg/m2)

Key exclusion criteria (11 listed)

Adults who are not capable of giving their own consent
Pre-existing neuropathy (assessed in the history and physical examination)
Coagulation disturbance (assessed on history and physical examination, if clinically necessary, by blood test, i.e. platelets ≤ 100,000, international normalized ratio ≥ 1.4 or prothrombin time ≥ 50)
Renal failure (assessed by history and physical examination, if considered clinically necessary, by blood test, i.e. creatinine ≥ 1.04 mg/dl)
Hepatic impairment (assessed by history and physical examination, if considered clinically necessary, by blood tests, i.e. transaminases (GGT ≥ 50 u/lt)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Intravenous study drug40mg parecoxib will be administered intravenously after general anesthesia induction and before tourniquet inflation and surgical incisión	Drug	Parecoxib
Intravenous saline solutionSaline solution (same volume as the study drug) will be administered intravenously after general anesthesia induction and before tourniquet inflation and surgical incision	Other	Placebo

Primary outcome

Morphine consumption
Time frame: 24 hours
Morphine consumed postoperatively during the first 24 hrs utilizing a patient-controlled analgesia device programmed 1mg/ml morphine solution, no infusion, 1ml dose, 8 minutes lockout.

29 secondary outcomes

Basal quadriceps strength in the operative side
Time frame: 1 hour before surgery
Basal level of pain during leg extension in the operative side
Time frame: 1 hour before surgery
Basal plasmatic creatinine
Time frame: 1 hour before surgery
Nerve block performance time
Time frame: 5 minutes after anesthesia induction (before surgical incision)
Incidence of Block complications
Time frame: 5 minutes after anesthesia induction and before surgical incision
Time to first morphine dose request
Time frame: 24 hours
Morphine consumption during first 48 hours
Time frame: 48 hours
Incidence of opioid related side effects
Time frame: 48 hours
Incidence of NSAIDs related clinical side effects
Time frame: 48 hours
Postoperative static pain level at 3 hours
Time frame: 3 hours
Postoperative dynamic pain level at 3 hours
Time frame: 3 hours
Postoperative static pain level at 6 hours
Time frame: 6 hours
Postoperative dynamic pain level at 6 hours
Time frame: 6 hours
Postoperative static pain level at 12 hours
Time frame: 12 hours
Postoperative dynamic pain level at 12 hours
Time frame: 12 hours
Postoperative static pain level at 24 hours
Time frame: 24 hours
Postoperative dynamic pain level at 24 hours
Time frame: 24 hours
Postoperative static pain level at 48 hours
Time frame: 48 hours
Postoperative dynamic pain level at 48 hours
Time frame: 48 hours
Medial malleolus sensory block level
Time frame: 3 hours
Lateral malleolus sensory block level
Time frame: 3hours
Medial malleolus sensory block level
Time frame: 24 hours
Lateral malleolus sensory block level
Time frame: 24 hours
Postoperative quadriceps strength
Time frame: 3 hours
Postoperative quadriceps strength
Time frame: 24 hours
Incidence of restriction to perform physiotherapy
Time frame: 6 hours
Incidence of restriction to perform physiotherapy
Time frame: 24 hours
Incidence of restriction to perform physiotherapy
Time frame: 48 hours
Postoperative plasmatic creatinine level
Time frame: 48 hours

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
Results publication: PubMed 30536047Aso K, Izumi M, Sugimura N, Okanoue Y, Kamimoto Y, Yokoyama M, Ikeuchi M. Additional benefit of local infiltration of analgesia to femoral nerve block in total knee arthroplasty: double-blind randomized control study. Knee Surg Sports Traumatol Arthrosc. 2019 Jul;27(7):2368-2374. doi: 10.1007/s00167-018-5322-7. Epub 2018 Dec 8.
Results publication: PubMed 26827847Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.
Results publication: PubMed 32474417Bai JW, An D, Perlas A, Chan V. Adjuncts to local anesthetic wound infiltration for postoperative analgesia: a systematic review. Reg Anesth Pain Med. 2020 Aug;45(8):645-655. doi: 10.1136/rapm-2020-101593. Epub 2020 May 30.
Results publication: PubMed 24939863Andersen LO, Kehlet H. Analgesic efficacy of local infiltration analgesia in hip and knee arthroplasty: a systematic review. Br J Anaesth. 2014 Sep;113(3):360-74. doi: 10.1093/bja/aeu155. Epub 2014 Jun 17.
Results publication: PubMed 12538372Hubbard RC, Naumann TM, Traylor L, Dhadda S. Parecoxib sodium has opioid-sparing effects in patients undergoing total knee arthroplasty under spinal anaesthesia. Br J Anaesth. 2003 Feb;90(2):166-72. doi: 10.1093/bja/aeg038.
Results publication: PubMed 11589257Harris SI, Kuss M, Hubbard RC, Goldstein JL. Upper gastrointestinal safety evaluation of parecoxib sodium, a new parenteral cyclooxygenase-2-specific inhibitor, compared with ketorolac, naproxen, and placebo. Clin Ther. 2001 Sep;23(9):1422-8. doi: 10.1016/s0149-2918(01)80117-x.
Results publication: PubMed 11808971Stoltz RR, Harris SI, Kuss ME, LeComte D, Talwalker S, Dhadda S, Hubbard RC. Upper GI mucosal effects of parecoxib sodium in healthy elderly subjects. Am J Gastroenterol. 2002 Jan;97(1):65-71. doi: 10.1111/j.1572-0241.2002.05265.x.
Results publication: PubMed 27428259Seangleulur A, Vanasbodeekul P, Prapaitrakool S, Worathongchai S, Anothaisintawee T, McEvoy M, Vendittoli PA, Attia J, Thakkinstian A. The efficacy of local infiltration analgesia in the early postoperative period after total knee arthroplasty: A systematic review and meta-analysis. Eur J Anaesthesiol. 2016 Nov;33(11):816-831. doi: 10.1097/EJA.0000000000000516.
Results publication: PubMed 25078268Affas F, Eksborg S, Wretenberg P, Olofsson C, Stephanson N, Stiller CO. Plasma concentration of ketorolac after local infiltration analgesia in hip arthroplasty. Acta Anaesthesiol Scand. 2014 Oct;58(9):1140-5. doi: 10.1111/aas.12371. Epub 2014 Jul 31.
Results publication: PubMed 33197808Laoruengthana A, Rattanaprichavej P, Reosanguanwong K, Chinwatanawongwan B, Chompoonutprapa P, Pongpirul K. A randomized controlled trial comparing the efficacies of ketorolac and parecoxib for early pain management after total knee arthroplasty. Knee. 2020 Dec;27(6):1708-1714. doi: 10.1016/j.knee.2020.10.005. Epub 2020 Nov 13.
Results publication: PubMed 33990439Chan E, Howle R, Onwochei D, Desai N. Infiltration between the popliteal artery and the capsule of the knee (IPACK) block in knee surgery: a narrative review. Reg Anesth Pain Med. 2021 Sep;46(9):784-805. doi: 10.1136/rapm-2021-102681. Epub 2021 May 14.
Results publication: PubMed 31985507Summers S, Mohile N, McNamara C, Osman B, Gebhard R, Hernandez VH. Analgesia in Total Knee Arthroplasty: Current Pain Control Modalities and Outcomes. J Bone Joint Surg Am. 2020 Apr 15;102(8):719-727. doi: 10.2106/JBJS.19.01035. No abstract available.
Individual participant dataSharing planned: No. deidentified data under reasonable request

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Intravenous study drug and Intravenous saline solution in people with Pain, Postoperative and Pain, Acute, run by University of Chile at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Morphine consumption (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05924412, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.