Thoracic Paravertebral Block in Pain Management After Renal Surgery
NCT02840526 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58
Last updated 2016-07-21
Summary
Objective: The objective of the study was to assess the usefulness of ThPVB in postoperative pain management after open renal resection surgery.
Design, setting, participants: It was a prospective, randomised, open label study held in a university hospital between 08.2013-12.2014. 58 Patients enrolled in the study were scheduled for elective open renal surgery (open nephrectomy or open nephron-sparing surgery) and randomised into two groups - group PVB (n=27) and group GEN (n=31).
Interventions: PVB group received preoperative ThPVB with 0,5% bupivacaine followed by general anaesthesia. GEN group received standard general anaesthesia. Both groups were treated postoperatively with oxycodone IV PCA (patient controlled analgesia) combined with non-opioid analgesics as rescue drugs. The investigators recorded pain severity in VAS, oxycodone requirement in time points, total oxycodone requirement, and sedation levels throughout the first 48h. The investigators measured opioid related adverse events 24 and 48 h postoperatively and patients satisfaction 48h postoperatively.
Conditions
- Postoperative Pain
Interventions
- PROCEDURE
-
Paravertebral blockade (PVB)
preoperative ThPVB performed unilaterally at Th10 level
- DRUG
-
Sopodorm
midazolam 0,1 mgkg-1 intravenously (anesthesia induction)
- DRUG
-
Propofol WZF
propofol 2 mgkg-1intravenously (anesthesia induction)
- DRUG
-
Nimbex
cis-atracurium 0,15 mgkg-1 intravenously (anesthesia induction)
- DRUG
-
Fentanyl WZF
fentanyl 1,5 µgkg-1 intravenously (anesthesia induction)
- DRUG
-
Sevorane
sevoflurane in 1 MAC (Minimal Alveolar Concentration) - anesthesia maintenance
- DEVICE
-
Intubation
Intratracheal intubation with a single lumen endotracheal tube
- DRUG
-
Oxynorm
1 mgml-1 concentration oxycodone solution intravenously
- DRUG
-
Paracetamol Kabi
1g paracetamol intravenously every 6 hours
- DRUG
-
Ketonal
100 mg ketoprofen intravenously every 12 hours
- DRUG
-
Bupivacaine WZF
0,3 ml kg-1 0,5% plain bupivacaine (regional anesthesia - paravertebral blockade)
Sponsors & Collaborators
-
Silesian University of Medicine
lead OTHER
Principal Investigators
-
Hanna Misiolek, MD PhD · Medical School of Silesia
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-05-31
- Primary Completion
- 2014-12-31
- Completion
- 2014-12-31
Countries
- Poland
Study Locations
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