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Analgesic Efficacy of Paravertebral Morphine

Primary Purpose

Acute Pain

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
PVB morphine
PVB bupivacaine
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

  • Adult patients subjected to mastectomy or renal surgery

Exclusion criteria

  • Patients complaining of coagulopathies
  • Patients with vertebral anomalies

Sites / Locations

  • DiabRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PVB morphine

PVB bupivacaine

Arm Description

Outcomes

Primary Outcome Measures

24 hour postoperative morphine consumption
the quantity of analgesic (morphine) consumed by the patient in the first postoperative 24 hour

Secondary Outcome Measures

VAS pain score (visual analogue pain score)
a scle in which 0 = no pain and 10 = maximum tolerable pain

Full Information

First Posted
December 17, 2017
Last Updated
February 7, 2019
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03379987
Brief Title
Analgesic Efficacy of Paravertebral Morphine
Official Title
Analgesic Efficacy of Paravertebral Morphine for Acute Postoperative Pain: Randomized Multicenter Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
August 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The investigator will test the analgesic efficacy of paravertebral morphine as an adjuvant to local anesthetics for acute postoperative pain following breast surgery and renal surgery

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PVB morphine
Arm Type
Experimental
Arm Title
PVB bupivacaine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
PVB morphine
Intervention Description
The PVB was performed under ultrasonographic guidance in the sitting position. Surgical disinfection of thoracoabdominal paravertebral area was done. A linear high-frequency transducer (10-12 MHz, Sonosite, Bothell, WA, USA) was used. The scanning process (Longitudinal out-of-plane technique) was started at 5-10 cm lateral to the spinous process of thoracic vertebrae to identify the rounded ribs and parietal pleura underneath. The transducer is then moved progressively more medially until the transverse processes are identified as more squared structure deeper to the ribs. A 100 mm needle was inserted out-of-plane to contact the transverse process of thoracic vertebra and then, walked off above the transverse process 1-1.5 cm deeper searching for loss of resistance injecting 10 ml of 0.25% bupivacaine + 3 mg morphine for group PVB morphine in incremental doses of 3 ml.
Intervention Type
Drug
Intervention Name(s)
PVB bupivacaine
Intervention Description
the same steps mentioned in group PVB morphine but the solution used for paravertebral block contain bupivacaine only 10 ml of 0.25% bupivacaine injected in in incremental doses of 3 ml.
Primary Outcome Measure Information:
Title
24 hour postoperative morphine consumption
Description
the quantity of analgesic (morphine) consumed by the patient in the first postoperative 24 hour
Time Frame
the first postoperative 24 hour
Secondary Outcome Measure Information:
Title
VAS pain score (visual analogue pain score)
Description
a scle in which 0 = no pain and 10 = maximum tolerable pain
Time Frame
we will assess every 4 hour in the first postoperative 24 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Adult patients subjected to mastectomy or renal surgery Exclusion criteria Patients complaining of coagulopathies Patients with vertebral anomalies
Facility Information:
Facility Name
Diab
City
Assiut
State/Province
Assuit
ZIP/Postal Code
71515
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diab Hetta, MD
Phone
+201091090009
Email
diabgetta25@gmail.com

12. IPD Sharing Statement

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Analgesic Efficacy of Paravertebral Morphine

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