Post-operative Pulmonary Function After Kidney Surgery Under Two Different Techniques
Evaluation of Post-operative Pulmonary Function After Open Kidney Surgery: Comparison Between Thoracic Epidural and Paravertebral Block
1 other identifier
interventional
50
1 country
1
Brief Summary
To assess the respiratory and analgesic effects of continuous thoracic paravertebral block versus thoracic epidural in patients undergoing kidney surgery
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2019
Longer than P75 for not_applicable
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
March 20, 2019
CompletedFirst Posted
Study publicly available on registry
March 21, 2019
CompletedStudy Start
First participant enrolled
May 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 29, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2022
CompletedDecember 2, 2022
November 1, 2022
3.3 years
March 20, 2019
November 30, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
vital capacity
measured by spirometer (Enraf-Nonius, Model SPIRO 601 medical Technologies)
24 hours after operation
forced vital capacity
measured by spirometer (Enraf-Nonius, Model SPIRO 601 medical Technologies)
24 hours after operation
forced expiratory volume in one second
measured by spirometer (Enraf-Nonius, Model SPIRO 601 medical Tecnologies)
24 hours after operation
Secondary Outcomes (2)
pain score
24 hours after operation
diaphragmatic excursion
24 hours after operation
Study Arms (2)
thoracic epidural group
ACTIVE COMPARATORpatients in this group will receive ultrasound guided thoracic epidural block preoperatively for pain management, continuous infusion of 0.5% bupivacaine through epidural catheter during operation and early post-operative period
paravertebral group
ACTIVE COMPARATORpatients in this group will receive ultrasound guided pararvertebral block preoperatively for pain management, continuous infusion of paravertebral bupivacaine 0.5% through paravetebral catheter during operation and early post-operative period
Interventions
thoracic epidural block with bupivacaine 0.25% will be given in the 8th thoracic space using ultrasound
paravertebral block with 0.25 bupivacaine will be given at the level of the incision using ultrasound
Eligibility Criteria
You may qualify if:
- ASA II, III
- elective kidney surgery
You may not qualify if:
- patient refusal
- contraindications to neuraxial blocks
- pneumonectomy
- planed postoperative mechanical ventilatoin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut University Hospital
Asyut, 71516, Egypt
Study Officials
- STUDY DIRECTOR
Mohammed G Abdelraheem, MD
Assiut University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
March 20, 2019
First Posted
March 21, 2019
Study Start
May 1, 2019
Primary Completion
August 29, 2022
Study Completion
November 30, 2022
Last Updated
December 2, 2022
Record last verified: 2022-11