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Thoracic Paravertebral Block in Pain Management After Renal Surgery

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Paravertebral blockade (PVB)
Sopodorm
Propofol WZF
Nimbex
Fentanyl WZF
Sevorane
Intubation
Oxynorm
Paracetamol Kabi
Ketonal
Bupivacaine WZF
Sponsored by
Silesian University of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring PVB, PCA, nephrectomy, postoperative pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Age 18-75
  • Scheduled for elective open nephrectomy or NSS
  • Gave written consent
  • BMI 19-30
  • ASA status I-III

Exclusion criteria:

  • Presence of chronic pain
  • Chronic mental conditions (depression)
  • Contraindications for PVB
  • Chest or spine deformations
  • Infection in planned site of PVB
  • Allergies for drugs used in the study
  • Cancer invading chest wall

Sites / Locations

  • Samodzielny Publiczny Szpital Kliniczny nr 1 SUM Zabrze

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

PVB group

GEN group

Arm Description

Thoracic paravertebral blockade PVB (preoperatively) Bupivacaine WZF Sopodorm Propofol WZF Fentanyl WZF Nimbex Sevorane Intubation Oxynorm Ketonal Paracetamol Kabi

Sopodorm Propofol WZF Fentanyl WZF Nimbex Sevorane Intubation Oxynorm Ketonal Paracetamol Kabi

Outcomes

Primary Outcome Measures

Difference in total amount of oxycodone needed in 48 hours after surgery

Secondary Outcome Measures

Difference in prevalence of opioid related adverse events in OBAS scale
Difference in pain level in VAS scale
Difference in level of sedation assessed in Ramsay scale
Difference in patient satisfaction level assessed in Likert scale

Full Information

First Posted
November 22, 2013
Last Updated
July 18, 2016
Sponsor
Silesian University of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02840526
Brief Title
Thoracic Paravertebral Block in Pain Management After Renal Surgery
Official Title
Thoracic Paravertebral Block in Postoperative Pain Management After Renal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
In PVB group before the induction of general anaesthesia a single shot thoracic paravertebral blockade was performed. ThPVB was performed on Th7-Th10 level, approximately 2,5 - 3 cm lateral from the top of the spinous process with prior ultrasound control of the depth of the transverse process and the pleura. To make the procedure safer the investigators used peripheral nerve stimulation with an isolated 10 cm needle with a start current of 2,5 mA. The needle was inserted until visible muscle activity from intercostal muscles appeared, with a current of 0,5-0,3mA (paravertebral space identification). Next 0,3 ml kg-1 0,5% plain bupivacaine was injected after negative aspiration for air and blood. The efficacy of the blockade was checked after 20 minutes with cold saline. In both groups, PVB and GEN general anaesthesia was induced with midazolam 0,1 mgkg-1, propofol 2 mgkg-1, cis-atracurium 0,15 mgkg-1 and fentanyl 1,5 µgkg-1. Patients were intubated with a standard single lumen tracheal tube. Anaesthesia was maintained with 1 MAC (Minimal Alveolar Concentration) sevoflurane. For surgical analgesia the investigators used fractional doses of fentanyl 1-3 mg kg-1 if HR (heart rate) or MBP (mean blood pressure) raised above 20% of basal values. Waking up from anaesthesia was in a post-anaesthesia care unit. Postoperative pain management schedule was identical in both groups. After the surgery, if pain appeared, the patient was given oxycodone i.v. titrated to achieve acceptable analgesia level or until side effects appeared. Every patient received a PCA (Patient controlled analgesia) device with a 1 mgml-1 concentration oxycodone solution with a programmed single bolus dose of 1 mg and a lockout time of 5 minutes. Additionally, patients were given 1g i.v. paracetamol every 6 hours and 100 mg of i.v. ketoprofen every 12 hours. For 48 h postoperatively, the investigators monitored HR, SBP (systolic blood pressure) , DBP (diastolic blood pressure), sedation level in Ramsay scale, pain intensity at rest in VAS (visual analogue score) scale, oxycodone requirement in pre-selected time points and total oxycodone requirement. The investigators also recorded opioid-related adverse events 24 and 48 h postoperatively in OBAS scale and patients' satisfaction regarding postoperative analgesia 48 h postoperatively in Likert scale.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
PVB, PCA, nephrectomy, postoperative pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PVB group
Arm Type
Experimental
Arm Description
Thoracic paravertebral blockade PVB (preoperatively) Bupivacaine WZF Sopodorm Propofol WZF Fentanyl WZF Nimbex Sevorane Intubation Oxynorm Ketonal Paracetamol Kabi
Arm Title
GEN group
Arm Type
Other
Arm Description
Sopodorm Propofol WZF Fentanyl WZF Nimbex Sevorane Intubation Oxynorm Ketonal Paracetamol Kabi
Intervention Type
Procedure
Intervention Name(s)
Paravertebral blockade (PVB)
Intervention Description
preoperative ThPVB performed unilaterally at Th10 level
Intervention Type
Drug
Intervention Name(s)
Sopodorm
Intervention Description
midazolam 0,1 mgkg-1 intravenously (anesthesia induction)
Intervention Type
Drug
Intervention Name(s)
Propofol WZF
Intervention Description
propofol 2 mgkg-1intravenously (anesthesia induction)
Intervention Type
Drug
Intervention Name(s)
Nimbex
Intervention Description
cis-atracurium 0,15 mgkg-1 intravenously (anesthesia induction)
Intervention Type
Drug
Intervention Name(s)
Fentanyl WZF
Intervention Description
fentanyl 1,5 µgkg-1 intravenously (anesthesia induction)
Intervention Type
Drug
Intervention Name(s)
Sevorane
Intervention Description
sevoflurane in 1 MAC (Minimal Alveolar Concentration) - anesthesia maintenance
Intervention Type
Device
Intervention Name(s)
Intubation
Intervention Description
Intratracheal intubation with a single lumen endotracheal tube
Intervention Type
Drug
Intervention Name(s)
Oxynorm
Intervention Description
1 mgml-1 concentration oxycodone solution intravenously
Intervention Type
Drug
Intervention Name(s)
Paracetamol Kabi
Intervention Description
1g paracetamol intravenously every 6 hours
Intervention Type
Drug
Intervention Name(s)
Ketonal
Intervention Description
100 mg ketoprofen intravenously every 12 hours
Intervention Type
Drug
Intervention Name(s)
Bupivacaine WZF
Intervention Description
0,3 ml kg-1 0,5% plain bupivacaine (regional anesthesia - paravertebral blockade)
Primary Outcome Measure Information:
Title
Difference in total amount of oxycodone needed in 48 hours after surgery
Time Frame
48 hours postoperatively
Secondary Outcome Measure Information:
Title
Difference in prevalence of opioid related adverse events in OBAS scale
Time Frame
24 hours, 48 hours after surgery
Title
Difference in pain level in VAS scale
Time Frame
48 hours postoperatively
Title
Difference in level of sedation assessed in Ramsay scale
Time Frame
48 hours after surgery
Title
Difference in patient satisfaction level assessed in Likert scale
Time Frame
48 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Age 18-75 Scheduled for elective open nephrectomy or NSS Gave written consent BMI 19-30 ASA status I-III Exclusion criteria: Presence of chronic pain Chronic mental conditions (depression) Contraindications for PVB Chest or spine deformations Infection in planned site of PVB Allergies for drugs used in the study Cancer invading chest wall
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanna Misiolek, MD PhD
Organizational Affiliation
Medical School of Silesia
Official's Role
Study Chair
Facility Information:
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 1 SUM Zabrze
City
Zabrze
State/Province
Slaskie
ZIP/Postal Code
41-800
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28731925
Citation
Copik M, Bialka S, Daszkiewicz A, Misiolek H. Thoracic paravertebral block for postoperative pain management after renal surgery: A randomised controlled trial. Eur J Anaesthesiol. 2017 Sep;34(9):596-601. doi: 10.1097/EJA.0000000000000673.
Results Reference
derived

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Thoracic Paravertebral Block in Pain Management After Renal Surgery

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