Postoperative Epidural Analgesia in Spine Fusion Surgery

NCT01838707 | Completed Phase 2

• 1 other identifier: 1976
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

postoperative; spine surgery

Outcome Measures

Primary Outcomes (1)

• Assessment of pain

  • 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.

  first 3 postoperative days

Secondary Outcomes (1)

• assessment of patients' satisfaction

  First 3 postoperative days

Other Outcomes (1)

• beta-endorphin

  1st postoperative day

Study Arms (3)

Bupivacaine

ACTIVE COMPARATOR

0.125% Bupivacaine HCL @ 4-5 ml/h

Drug: 0.125% Bupivacaine HCL @ 4-5 ml/h

Bupivacaine, Morphine

ACTIVE COMPARATOR

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

Bupivacaine, Fentanyl

ACTIVE COMPARATOR

0.125% Bupivacaine, Fentanyl 100 mic @ 3-5 ml/h

Drug: 0.125% Bupivacaine, Fentanyl 100 mic @ 3-5 ml/h

Interventions

0.125% Bupivacaine HCL @ 4-5 ml/h DRUG

Bupivacaine

0.125% Bupivacaine HCL , Morphine sulphate @ 3 mg 3-5 ml/h DRUG

Bupivacaine, Morphine

0.125% Bupivacaine, Fentanyl 100 mic @ 3-5 ml/h DRUG

Bupivacaine, Fentanyl

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients undergoing spine fusion surgery.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Pain

Interventions

Bupivacaine; Morphine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Omnia A Abd El Raof, M.Sc.

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer of anesthesia and ICU, Assiut University

Study Record Dates

• First Submitted: April 20, 2013
• First Posted: April 24, 2013
• Study Start: December 1, 2007
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: April 25, 2013

Record last verified: 2013-04

Locations

EG (1)