Analgesic Efficacy of Paravertebral Morphine
1 other identifier
interventional
120
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2017
CompletedFirst Posted
Study publicly available on registry
December 20, 2017
CompletedStudy Start
First participant enrolled
January 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedFebruary 11, 2019
February 1, 2019
1.5 years
December 17, 2017
February 7, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
24 hour postoperative morphine consumption
the quantity of analgesic (morphine) consumed by the patient in the first postoperative 24 hour
the first postoperative 24 hour
Secondary Outcomes (1)
VAS pain score (visual analogue pain score)
we will assess every 4 hour in the first postoperative 24 hour
Study Arms (2)
PVB morphine
EXPERIMENTALPVB bupivacaine
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- Adult patients subjected to mastectomy or renal surgery
You may not qualify if:
- Patients complaining of coagulopathies
- Patients with vertebral anomalies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Diab
Asyut, Assuit, 71515, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- anesthesia and pain management departmewnt, SECI
Study Record Dates
First Submitted
December 17, 2017
First Posted
December 20, 2017
Study Start
January 1, 2018
Primary Completion
July 1, 2019
Study Completion
August 1, 2019
Last Updated
February 11, 2019
Record last verified: 2019-02