DDrare: Database of Drug Development for Rare Diseases

Searched query = "Spinal stenosis", "Extensive spinal canal stenosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = 0.5% marcaine; 0.9% Saline; 0002-8971; 1mg/kg/hr TXA intravenous infusion till the last suture; AK1320 MS; Acetaminophen; Acetate; Adjunctive analgesics; Adjunctive anti-depressants; AlloGen-LI; Alprostadil; Amino acids; Aminocaproic acid; Amniotic Fluid Allograft; Apple; Bilateral transforaminal epidural steroid injections; Bone Marrow Concentrate; Botulinum toxin type A; Botulinum toxin type A (Nabota®) injection into the gastrocnemius muscle; Bupivacaine; Bupivacaïne HCl 0,125% / Sufentanil 50 µg flacon à 50 ml; Buprenorphine; CO; Caudal Epidural Injection with Celestone; Caudal Epidural Injection with DepoMedrol; Caudal Epidural Injection with generic Celestone; Caudal epidural injection; Celebrex 200Mg Capsule; Celecoxib; Cilostazol; Combination Product: Goldic serum; Control group; Creatinine; DEXMEDETOMIDINE; DEXMEDETOMIDINE HYDROCHLORIDE; Darvocet; Decadron Phosphate, Injectable; Deksmedetomidiini; Demineralized Bone Matrix; DepoMedrol; Depomedrol; Device: Apple Watch and App; Device: Bioactive Glass-Ceramic Spacer; Device: Cervical Orthosis (CO); Device: Interbody cage (PEEK); Device: Interbody cage (titanium); Device: MILD® (Minimally Invasive Lumbar Decompression); Device: MRI; Device: MasterGraft Granules; Device: No Orthosis; Device: Philips Intelivue MP70 monitor; Device: Pleth Variability Index (PVI); Device: Therm-AppTM TH, thermographic camera; Device: Titanium cage; Dexamethasone; Dexamethasone sodium phosphate; Dexdor; Dexmedetomidine; Dexmedetomidine group; Dexmedetomidine with ropivacaine; Dextrose; Diphenhydramine; EACA; ESKETAMINE HYDROCHLORIDE; Epidural Steroid Injection; Epidural injection; Epidural local anesthetic injection; Epidural steroid injection; Epsilon-Aminocaproic Acid (EACA); Erector spinae plane block (Group E); Erythropoietin; Esketamine; Fentanyl; Forsteo; Forteo; Gabapentin; Heparin; Herbal medicine; Hyaluronic Acid; Hyaluronic acid; Hydromorphone; I-FACTOR; KETAMINE; Kenalog Injectable Product; Ketamine; Ketanest; Ketanest-S; Ketorolac; Limaprost; Liposomal bupivacaine; Lumbar Interbody Fusion with Autograft; Lumbar Interbody Fusion with NeoFuse; MONITOR; Magnesium; Magnesium with ropivacaine; Midazolam; Mirogabalin; Misoprostol; Modal; Modified-thoracolumbar interfascial plane block; Morphine; Morphine PCA; Multi-modal pain management [Acetaminophen + Gabapentin]; Multi-modal pain management [Fentanyl]; Multi-modal pain management [Intravenous Ketamine]; Multi-modal pain management [Valium + Gabapentin]; NS-304; NS-304 Placebo; NSAIDs; NeoFuse; Nicardipine; Normal saline; NuCel; OXYCODONE; OXYCODONE HYDROCHLORIDE; Oksikodoni; Opana; Other: Control; Other: Conventional PCA mode; Other: Epiduroscopy; Other: Group Exercise: community setting; Other: Individualized exercises: clinical setting; Other: Joint Mobilizations (spine, sacroiliac, hip); Other: Optimizing basal infusion (B.I); Other: Other intervention(s); Other: no intervention; Other: physical therapy; Oxanest; Oxycodone; Oxycodone Orion; Oxygen; PCA; PLF with NeoFuse; Parathyroid hormone; Phosphate; Polydeoxyribonucleotides; Predinose oral; Pregabalin; Pregabalin 75mg; Procedure: Acupuncture; Procedure: Allograft; Procedure: Bee venom pharmacopuncture; Procedure: Chuna manipulation; Procedure: Chuna manual medicine; Procedure: Cupping; Procedure: Electroacupuncture; Procedure: Epidural Steroid Injection; Procedure: Epidural local anesthetic injection; Procedure: Epidural steroid with local anesthetic injection; Procedure: Lumbar epidural injection; Procedure: MILD Procedure; Procedure: Manual therapy; Procedure: Other intervention(s); Procedure: PLF with autograft; Procedure: Percutaneous Lumbar Decompression; Procedure: Pharmacopuncture; Procedure: epidural steroid (dexamethasone) injection; Procedure: lumbar interlaminar epidural steroid injection; Procedure: posterolateral spinal fusion with instrumentation; Prolotherapy solution of 20% dextrose; Remifentanil; RhPTH; RhPTH (1-34); Ropivacaine; Ropivacaine plus normal saline; S-ketamine; S-ketamine & midazolam; Selexipag; Standard analgesia use [Fentanyl]; Standard analgesia use [Hydromorphone]; Standard analgesia use [Oxygen]; Standard analgesia use [Volatile Anesthesia]; Steroid injections; Sufentanil; Sugar Pill; Teicoplanin; Teriparatide; Teriparatide [rDNA origin] contains recombinant human parathyroid hormone (1-34); Titanium; Tramadol; Tramadol with ropivacaine; Tranexamic Acid; Tranexamic Acid 100 MG/ML; Tranexamic acid; Transdermal fentanyl matrix, gabapentin; Transforaminal Epidural Injection; Triamcinolone; Triamcinolone Acetonide and normal saline solution; Tylenol; Vancomycin; ViviGen Cellular Bone Matrix; With U-VANCO (vancomycin hydrochloride); Without U-VANCO (vancomycin hydrochloride); Wound topically irrigated with 500mg TXA; Xylocaine

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT04391855 (ClinicalTrials.gov)	May 10, 2020	13/5/2020	Wound Infiltration With Tramadol, Dexmedetomidine, or Magnesium Plus Ropivacaine for Pain Relief After Spine Surgery	Effect of Wound Infiltration With Tramadol, Dexmedetomidine, or Magnesium Sulfate as Adjuncts to the Local Anesthetic on Pain Relief After Spine Surgery	Analgesia;Pain, Postoperative;Spinal Stenosis;Spinal Disease	Drug: Tramadol with ropivacaine;Drug: Dexmedetomidine with ropivacaine;Drug: Magnesium with ropivacaine;Drug: Ropivacaine plus normal saline	Aristotle University Of Thessaloniki	NULL	Recruiting	18 Years	80 Years	All	78	Phase 4	Greece
2	NCT02902380 (ClinicalTrials.gov)	September 27, 2016	6/9/2016	The Effect of Dexmedetomidine on Neuroendocrine Stress Hormone Release and Heart Rate Variability in Patients Undergoing Major Spinal Surgery		Spinal Stenosis	Drug: dexmedetomidine group;Drug: control group	Yonsei University	NULL	Completed	20 Years	70 Years	All	52	N/A	Korea, Republic of
3	EUCTR2015-002694-37-FI (EUCTR)	01/09/2016	04/01/2016	Dexmedetomidine is a drug that is used mainly for sedation in the intensive care unit. Purpose of this study is to determine does Dexmedetomidine infusion provide pain management in the postoperative period and prevent chronic pain. Patients are randomized to receive either placebo or dexmedetomidine infusion. DEXPAIN-study has been approved by Kuopio university hospitals ethics committee.	Dexmedetomidine infusion in pain management during low back surgeryDexmedetomidine is an alpha-2-adrenergic agonist that is used mainly for sedation in the intensive care unit. Alpha-2-adrenoceptors agonists have several beneficial actions in a surgical patient. They decrease symphatetic tone, reduce anesthetic and opioid requirements and cause sedation and analgesia. Pain after low back surgery is intense and can become chronic. We need a new drug to manage pain during postoperative period and to prevent chronic pain.DEXPAIN-study has been approved by Kuopio university hospitals ethics committee. Study is single centered, randomized and placebo-controlled study. A total of 60 patients scheduled for low back surgery will be enrolled in this study. Patients eligibility will be assessed by pre-determined inclusion-exclusion-criteria. Purpose of this study is to determine does Dexmedetomidine infusion provide pain management in the postoperative period and prevent chronic pain. Patients are randomized to receive either placebo or dexmedetomidine infusion. Patients in the dexmedetomidine group receive dexmedetomidine loading dose 1ug/kg for 10 minutes and continuous infusion 1.4 ug/kg/h during surgery and post-anesthesia care unit. Total infusion time will be four hours. Anesthesia is standardized and post-operative pain is treated with patient controlled analgesia made of oxycodone. Questionnaires will be used to assess pain control.Study is scheduled to start as soon as we obtain permission from Finnish Medicines Agency and receive sufficient funding.	Low back pain, Discus prolapse, Spinal stenosis;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]	Trade Name: Dexmedetomidine Product Name: Dexdor INN or Proposed INN: DEXMEDETOMIDINE	Kuopio University hospital	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes			Finland
4	EUCTR2014-003252-31-FI (EUCTR)	15/05/2015	22/04/2015	Dose-response of dexmedetomidine in patient controlled analgesia in orthopaedic surgery patients	Dose response study of Patient Controlled Analgesia (PCA) of Dexmedetomidine in orthopaedic spine surgery patients - DoserespDex_2.0	Patients, who are scheduled for elective posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation MedDRA version: 17.1;Level: LLT;Classification code 10041595;Term: Spinal stenosis lumbar;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]	Trade Name: Dexdor INN or Proposed INN: deksmedetomidiini Other descriptive name: DEXMEDETOMIDINE HYDROCHLORIDE Trade Name: Oxanest INN or Proposed INN: oksikodoni Other descriptive name: OXYCODONE HYDROCHLORIDE	University of Turku	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Finland
5	NCT01377623 (ClinicalTrials.gov)	September 2010	3/1/2011	Pilot Study on the Effect of Dexmedetomidine on Inflammatory Responses in Patients Undergoing Lumbar Spinal Fusion	Pilot Study on the Effect of Dexmedetomidine on Inflammatory Responses in Patients Undergoing Lumbar Spinal Fusion	Spinal Stenosis;Inflammation	Drug: Dexmedetomidine group;Drug: Placebo group	New York University School of Medicine	Hospira, now a wholly owned subsidiary of Pfizer	Terminated	18 Years	N/A	All	66	N/A	United States
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	NCT00808665 (ClinicalTrials.gov)	June 2009	15/12/2008	Intraoperative Infusion of Precedex to Reduce Length of Stay After Lumbar Spine Fusion	Does Continuous Perioperative Dexmedetomidine Infusion Reduce Time to Discharge in Patients Undergoing Major Lumbar Fusion? A Double-Blind, Placebo-Controlled Study	Spinal Fusion Acquired;Spinal Stenosis;Lesions of Lumbosacral Intervertebral Disc;Spinal Diseases	Drug: Dexmedetomidine;Drug: 0.9% Saline	Vanderbilt University Medical Center	NULL	Completed	18 Years	85 Years	All	68	Phase 4	United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04391855
(ClinicalTrials.gov)

May 10, 2020

13/5/2020

Wound Infiltration With Tramadol, Dexmedetomidine, or Magnesium Plus Ropivacaine for Pain Relief After Spine Surgery

Effect of Wound Infiltration With Tramadol, Dexmedetomidine, or Magnesium Sulfate as Adjuncts to the Local Anesthetic on Pain Relief After Spine Surgery

Analgesia;Pain, Postoperative;Spinal Stenosis;Spinal Disease

Drug: Tramadol with ropivacaine;Drug: Dexmedetomidine with ropivacaine;Drug: Magnesium with ropivacaine;Drug: Ropivacaine plus normal saline

Aristotle University Of Thessaloniki

NULL

Recruiting

18 Years

80 Years

All

Phase 4

Greece

NCT02902380
(ClinicalTrials.gov)

September 27, 2016

6/9/2016

The Effect of Dexmedetomidine on Neuroendocrine Stress Hormone Release and Heart Rate Variability in Patients Undergoing Major Spinal Surgery

Spinal Stenosis

Drug: dexmedetomidine group;Drug: control group

Yonsei University

NULL

Completed

20 Years

70 Years

All

N/A

Korea, Republic of

EUCTR2015-002694-37-FI
(EUCTR)

01/09/2016

04/01/2016

Dexmedetomidine is a drug that is used mainly for sedation in the intensive care unit. Purpose of this study is to determine does Dexmedetomidine infusion provide pain management in the postoperative period and prevent chronic pain. Patients are randomized to receive either placebo or dexmedetomidine infusion. DEXPAIN-study has been approved by Kuopio university hospitals ethics committee.

Dexmedetomidine infusion in pain management during low back surgeryDexmedetomidine is an alpha-2-adrenergic agonist that is used mainly for sedation in the intensive care unit. Alpha-2-adrenoceptors agonists have several beneficial actions in a surgical patient. They decrease symphatetic tone, reduce anesthetic and opioid requirements and cause sedation and analgesia. Pain after low back surgery is intense and can become chronic. We need a new drug to manage pain during postoperative period and to prevent chronic pain.DEXPAIN-study has been approved by Kuopio university hospitals ethics committee. Study is single centered, randomized and placebo-controlled study. A total of 60 patients scheduled for low back surgery will be enrolled in this study. Patients eligibility will be assessed by pre-determined inclusion-exclusion-criteria. Purpose of this study is to determine does Dexmedetomidine infusion provide pain management in the postoperative period and prevent chronic pain. Patients are randomized to receive either placebo or dexmedetomidine infusion. Patients in the dexmedetomidine group receive dexmedetomidine loading dose 1ug/kg for 10 minutes and continuous infusion 1.4 ug/kg/h during surgery and post-anesthesia care unit. Total infusion time will be four hours. Anesthesia is standardized and post-operative pain is treated with patient controlled analgesia made of oxycodone. Questionnaires will be used to assess pain control.Study is scheduled to start as soon as we obtain permission from Finnish Medicines Agency and receive sufficient funding.

Low back pain, Discus prolapse, Spinal stenosis;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Trade Name: Dexmedetomidine
Product Name: Dexdor
INN or Proposed INN: DEXMEDETOMIDINE

Kuopio University hospital

NULL

Authorised-recruitment may be ongoing or finished

Female: no
Male: yes

Finland

EUCTR2014-003252-31-FI
(EUCTR)

15/05/2015

22/04/2015

Dose-response of dexmedetomidine in patient controlled analgesia in orthopaedic surgery patients

Dose response study of Patient Controlled Analgesia (PCA) of Dexmedetomidine in orthopaedic spine surgery patients - DoserespDex_2.0

Patients, who are scheduled for elective posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation
MedDRA version: 17.1;Level: LLT;Classification code 10041595;Term: Spinal stenosis lumbar;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

Trade Name: Dexdor
INN or Proposed INN: deksmedetomidiini
Other descriptive name: DEXMEDETOMIDINE HYDROCHLORIDE
Trade Name: Oxanest
INN or Proposed INN: oksikodoni
Other descriptive name: OXYCODONE HYDROCHLORIDE

University of Turku

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Finland

NCT01377623
(ClinicalTrials.gov)

September 2010

3/1/2011

Pilot Study on the Effect of Dexmedetomidine on Inflammatory Responses in Patients Undergoing Lumbar Spinal Fusion

Spinal Stenosis;Inflammation

Drug: Dexmedetomidine group;Drug: Placebo group

New York University School of Medicine

Hospira, now a wholly owned subsidiary of Pfizer

Terminated

18 Years

N/A

All

N/A

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT00808665
(ClinicalTrials.gov)

June 2009

15/12/2008

Intraoperative Infusion of Precedex to Reduce Length of Stay After Lumbar Spine Fusion

Does Continuous Perioperative Dexmedetomidine Infusion Reduce Time to Discharge in Patients Undergoing Major Lumbar Fusion? A Double-Blind, Placebo-Controlled Study

Spinal Fusion Acquired;Spinal Stenosis;Lesions of Lumbosacral Intervertebral Disc;Spinal Diseases

Drug: Dexmedetomidine;Drug: 0.9% Saline

Vanderbilt University Medical Center

NULL

Completed

18 Years

85 Years

All

Phase 4

United States