Neodolpasse® Infusion Solution Versus Diclofenac 75 mg Infusion in the Treatment of Postoperative Pain After Elective Knee Surgery

NCT03493490 | Completed Phase 4 DMC

• 1 other identifier: NDOL-001-2016
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The clinical study is planned as a double-blind, randomised, placebo-controlled, parallel-group, single-centre exploratory clinical study with the aim to investigate the analgesic efficacy of the Neodolpasse® Infusion Solution in comparison to a 75 mg diclofenac only infusion. Included will be Patients receiving elective cruciate ligament surgery. The effectiveness will be measured by the use of additional analgesic medication via PCA during the first 24 hours postoperatively as well as by using a Visual Analogue Scale (VAS). Furthermore the local and systemic tolerability and safety of the clinical study medications (i.e. Neodolpasse® Infusion Solution and 75 mg diclofenac only infusion) will be assessed.

Conditions

Pain, Postoperative; Analgesic Adverse Reaction; Cruciate Ligament Rupture

Keywords

Double-Blind Method; placebo-controlled; parallel-group; single-centre; exploratory clinical study

Outcome Measures

Primary Outcomes (1)

• PCA-use: Total dose of PCA alangetics required over the first 24 hours post-surgery. Measured in mg

  amount of pca analgetic administered

  within 24 hours

Secondary Outcomes (1)

• VAS-Scale: Pain relief will be tracked during the infusion periods and until 48 hours after the surgical intervention by using a Visual Analogue Scale (VAS).

  after 24 hours

Study Arms (3)

Neodolpasse

EXPERIMENTAL

In the Neodolpasse® arm patients receive two infusions over 30 minutes after fixation of the graft replacement and with a time interval of 8 hours each during the first 24 hours. Neodolpasse® Infusion Solution combines 75 mg (250 mL) of the NSAID diclofenac with 30 mg of the muscle-relaxant orphenadrine.

Drug: Neodolpasse

Diclofenac

ACTIVE COMPARATOR

In the Diclofenac arm patients receive two infusions over 30 minutes after fixation of the graft replacement and with a time interval of 8 hours each during the first 24 hours. The Infusion solution contains 75 mg (250 mL) of the NSAID diclofenac.

Drug: Diclofenac

Placebo

PLACEBO COMPARATOR

In the Placebo arm patients receive two physiologic saline infusion (250 mL) over 30 minutes after fixation of the graft replacement and with a time interval of 8 hours each during the first 24 hours.

Drug: Placebo

Interventions

Neodolpasse DRUG

Patients will receive two infusions containing 75 mg diclofenac and 30 mg orphenadrine citrate 30 minutes after fixation of the graft replacement and with a time interval of 8 hours.

Neodolpasse

Diclofenac DRUG

Patients will receive two infusions containing 75 mg diclofenac 30 minutes after fixation of the graft replacement and with a time interval of 8 hours.

Diclofenac

Placebo DRUG

Patients will receive two physiologic saline infusions 30 minutes after fixation of the graft replacement and with a time interval of 8 hours.

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective cruciate ligament surgery
• Confirmed patient suitability for planned surgery
• Legally valid signed written informed consent provided
• Female patients are confirmed non-pregnant (negative pregnancy test) or not breast feeding
• Adequate renal function defined by a creatinine value lower than 1.80 mg/dL for male and ower than 1.50 mg/dL for female patients
• No known intolerabilities or hypersensitivities to any part of the IMP / control medication
• No reoperation/revision within 6 months after the initial surgery
• Absence of history of abuse of analgesics or other drug
• No analgesics within 48 hours prior to surgery (surgery-related medication excluded)
• No current / recent (within 4 weeks prior to enrolment) experimental treatment
• No current / recent (within 4 weeks prior to enrolment) participation in another clinical study
• No foreseeable difficulties with regard to protocol compliance
• No known hypersensibility against the active ingredients diclofenac, orphenadrine, remifentanil, propofol, rocuronium, and hydromorphone
• No known hypersensibility against the other ingredients of the investigational medicinal product
• Absence of congestive heart failure classes 2 or higher according to the NYHA classification

You may not qualify if:

• Major complications during surgery possibly leading to problems in the handling of the PCA or subsequently with the experimental treatment
• Intolerable adverse events or any serious adverse event
• Severe violation of the clinical study protocol
• Withdrawal of patient informed consent

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (5)

• Jin F, Chung F. Multimodal analgesia for postoperative pain control. J Clin Anesth. 2001 Nov;13(7):524-39. doi: 10.1016/s0952-8180(01)00320-8.

  PMID: 11704453 BACKGROUND

• Kehlet H. Synergism between analgesics. Ann Med. 1995 Apr;27(2):259-62. doi: 10.3109/07853899509031968.

  PMID: 7632423 BACKGROUND

• Kornhuber J, Parsons CG, Hartmann S, Retz W, Kamolz S, Thome J, Riederer P. Orphenadrine is an uncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist: binding and patch clamp studies. J Neural Transm Gen Sect. 1995;102(3):237-46. doi: 10.1007/BF01281158.

  PMID: 8788072 BACKGROUND

• Hunskaar S, Berge OG, Hole K. Orphenadrine citrate increases and prolongs the antinociceptive effects of paracetamol in mice. Acta Pharmacol Toxicol (Copenh). 1986 Jul;59(1):53-9. doi: 10.1111/j.1600-0773.1986.tb00134.x.

  PMID: 3766151 BACKGROUND

• Luetz A, Heymann A, Radtke FM, Chenitir C, Neuhaus U, Nachtigall I, von Dossow V, Marz S, Eggers V, Heinz A, Wernecke KD, Spies CD. Different assessment tools for intensive care unit delirium: which score to use? Crit Care Med. 2010 Feb;38(2):409-18. doi: 10.1097/CCM.0b013e3181cabb42.

  PMID: 20029345 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Neodolpasse; Diclofenac

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Oliver Kimberger, M.D.

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Head of Department of Anesthesiology, General Intensive Care and Pain Medicine

Model Details: Randomization of the study patient takes place pre-surgery. Successfully randomized patients will receive two infusions over 30 minutes after fixation of the graft replacement and with a time interval of 8 hours each during the first 24 hours postoperatively. All patients will be provided with a PCA device as postoperative rescue medication. Consequently the possibility of an inadequate postoperative pain treatment in the study patients is very low, also in the placebo group.

Study Record Dates

• First Submitted: March 16, 2018
• First Posted: April 10, 2018
• Study Start: March 1, 2018
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: March 20, 2023

Record last verified: 2023-03

Locations

AU (1)