NCT03178708

Brief Summary

During the surgical procedure of scoliosis correction, large surgery extent and long-lasting strong nociceptive stimulation lead to postoperative pain formation of greater intensity compared with other orthopedic interventions. In these patients, duration of postoperative symptoms is longer, and may lead to persistent pain formation due to developing neuroplastic changes in the central nervous system.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 7, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

January 12, 2021

Status Verified

January 1, 2021

Enrollment Period

2.4 years

First QC Date

June 3, 2017

Last Update Submit

January 8, 2021

Conditions

Spinal Curvatures

Outcome Measures

Primary Outcomes (1)

  • postoperative opioid consumption

    24 hours postoperative

Study Arms (2)

Group A amantadine sulfate

ACTIVE COMPARATOR

the patients will receive amantadine sulfate infusion using the dose 200 mg slowly I.V 3 hours prior to the surgery

Drug: Group A amantadine sulfate

Group B ringer lactate

PLACEBO COMPARATOR

the patients will receive 500 ml ringer lactate infusion slowly i.v 3 hours prior to surgery.

Other: Group B ringer lactate

Interventions

Group A amantadine sulfateDRUG

infusion solution for slowly intravenous application 3 hours preoperative

Also known as: PK-Merz Infusion amantadine sulfate
Group A amantadine sulfate
Group B ringer lactateOTHER

infusion solution for intravenous application 3 hours preoperative

Also known as: ringer lactate, Lactated ringer
Group B ringer lactate

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Being candidate for spine deformity correction surgery(scoliosis and kyphosis )
  • Willing to participate in the study

You may not qualify if:

  • Patient refusal
  • Patients with chronic kidney, lungs,Gastrointestinal tract, liver, or cardiovascular diseases.
  • Pregnant or breastfeeding women.
  • Allergy to any of the study medications and taking medications that could significantly interact with amantadine (tramadol, atropine,antipsychotic medications)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut governorate

Asyut, Egypt

Location

Related Publications (4)

  • Snijdelaar DG, Koren G, Katz J. Effects of perioperative oral amantadine on postoperative pain and morphine consumption in patients after radical prostatectomy: results of a preliminary study. Anesthesiology. 2004 Jan;100(1):134-41. doi: 10.1097/00000542-200401000-00022.

    PMID: 14695734RESULT

  • Eisenberg E, Pud D, Koltun L, Loven D. Effect of early administration of the N-methyl-d-aspartate receptor antagonist amantadine on the development of postmastectomy pain syndrome: a prospective pilot study. J Pain. 2007 Mar;8(3):223-9. doi: 10.1016/j.jpain.2006.08.003. Epub 2006 Sep 22.

    PMID: 16996315RESULT

  • Gerner P. Postthoracotomy pain management problems. Anesthesiol Clin. 2008 Jun;26(2):355-67, vii. doi: 10.1016/j.anclin.2008.01.007.

    PMID: 18456219RESULT

  • Singla N, Rock A, Pavliv L. A multi-center, randomized, double-blind placebo-controlled trial of intravenous-ibuprofen (IV-ibuprofen) for treatment of pain in post-operative orthopedic adult patients. Pain Med. 2010 Aug;11(8):1284-93. doi: 10.1111/j.1526-4637.2010.00896.x. Epub 2010 Jun 30.

    PMID: 20609131RESULT

MeSH Terms

Conditions

Spinal Curvatures

Interventions

Ringer's Lactate

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: the role of preoperative administration of Amantadine Sulphate on the duration of wake up test and postoperative opiod consumption in patients undergoing major spine deformities corrective surgeries.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 3, 2017

First Posted

June 7, 2017

Study Start

August 1, 2017

Primary Completion

December 30, 2019

Study Completion

December 30, 2019

Last Updated

January 12, 2021

Record last verified: 2021-01

Locations

EG(1)