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Postoperative Epidural Analgesia in Spine Fusion Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01838707
Recruitment Status : Completed
First Posted : April 24, 2013
Last Update Posted : April 25, 2013
Sponsor:
Information provided by (Responsible Party):
Omnia Askar, Assiut University

Brief Summary:
we aim to compare the analgesic effect of 0.125% bupivacaine HCL, 0.125% bupivacaine HCL + Morphine sulphate 3 mg, 0.125% bupivacaine HCL + Fentanyl 100 micro gram both at rest and mobilization maneuvers.

Condition or disease Intervention/treatment Phase
Pain Drug: 0.125% Bupivacaine HCL @ 4-5 ml/h Drug: 0.125% Bupivacaine HCL , Morphine sulphate @ 3 mg 3-5 ml/h Drug: 0.125% Bupivacaine, Fentanyl 100 mic @ 3-5 ml/h Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Postoperative Epidural Analgesia in Spine Fusion Surgery
Study Start Date : December 2007
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Bupivacaine
0.125% Bupivacaine HCL @ 4-5 ml/h
Drug: 0.125% Bupivacaine HCL @ 4-5 ml/h
Active Comparator: Bupivacaine, Morphine
0.125% Bupivacaine HCL , Morphine sulphate 3 mg @ 3-5 ml/h
Drug: 0.125% Bupivacaine HCL , Morphine sulphate @ 3 mg 3-5 ml/h
Active Comparator: Bupivacaine, Fentanyl
0.125% Bupivacaine, Fentanyl 100 mic @ 3-5 ml/h
Drug: 0.125% Bupivacaine, Fentanyl 100 mic @ 3-5 ml/h



Primary Outcome Measures :
  1. Assessment of pain [ Time Frame: first 3 postoperative days ]
    • Pain will be assessed using the VAS ranging from "0" (no pain) to "10" (worst imaginable pain). Pain will be evaluated at rest, while coughing, and during mobilization. Maneuvers of particular clinical importance for postoperative mobilization (alone and with help) will be chosen: Turning in bed, standing in front of the bed and walking, and using the toilet without help. The time needed until the patient can first successfully perform these maneuvers will be documented.


Secondary Outcome Measures :
  1. assessment of patients' satisfaction [ Time Frame: First 3 postoperative days ]
    verbal rating score will be used (4 = very satisfied, 3 = satisfied, 2 = neutral, 1 = dissatisfied, and 0 = very dissatisfied).


Other Outcome Measures:
  1. beta-endorphin [ Time Frame: 1st postoperative day ]
    3 serum samples for beta-endorphin will be taken 1st one preoperative base line , 2nd at VAS more than 3 at rest ,3rd when VAS less than 2 at rest



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing spine fusion surgery.

Exclusion Criteria:

  • Drug addiction. Intraoperative dural tear. Uses of opioids drug for any reason in the previous 48 hours. Mental dysfunction. Spinal fusion for any infectious or malignant causes.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01838707


Locations
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Egypt
Assiut University Hospital
Assiut, Egypt, 71111
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Omnia A Abd El Raof, M.Sc. Assiut University

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Responsible Party: Omnia Askar, assistant lecturer of anesthesia and ICU, Assiut University, Assiut University
ClinicalTrials.gov Identifier: NCT01838707    
Other Study ID Numbers: 1976
First Posted: April 24, 2013    Key Record Dates
Last Update Posted: April 25, 2013
Last Verified: April 2013
Keywords provided by Omnia Askar, Assiut University:
postoperative
spine surgery
Additional relevant MeSH terms:
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Fentanyl
Morphine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General