Thoracic Paravertebral Block in Pain Management After Renal Surgery

NCT02840526 | Completed

• 1 other identifier: SUM-PSK-1
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

PVB; PCA; nephrectomy; postoperative pain

Outcome Measures

Primary Outcomes (1)

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

  48 hours postoperatively

Secondary Outcomes (4)

• Difference in prevalence of opioid related adverse events in OBAS scale

  24 hours, 48 hours after surgery

• Difference in pain level in VAS scale

  48 hours postoperatively

• Difference in level of sedation assessed in Ramsay scale

  48 hours after surgery

• Difference in patient satisfaction level assessed in Likert scale

  48 hours after surgery

Study Arms (2)

PVB group

EXPERIMENTAL

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

Procedure: Paravertebral blockade (PVB); Drug: Sopodorm; Drug: Propofol WZF; Drug: Nimbex; Drug: Fentanyl WZF; Drug: Sevorane; Device: Intubation; Drug: Oxynorm; Drug: Paracetamol Kabi; Drug: Ketonal; Drug: Bupivacaine WZF

GEN group

OTHER

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

Drug: Sopodorm; Drug: Propofol WZF; Drug: Nimbex; Drug: Fentanyl WZF; Drug: Sevorane; Device: Intubation; Drug: Oxynorm; Drug: Paracetamol Kabi; Drug: Ketonal

Interventions

Paravertebral blockade (PVB) PROCEDURE

preoperative ThPVB performed unilaterally at Th10 level

PVB group

Sopodorm DRUG

midazolam 0,1 mgkg-1 intravenously (anesthesia induction)

GEN group; PVB group

Propofol WZF DRUG

propofol 2 mgkg-1intravenously (anesthesia induction)

GEN group; PVB group

Nimbex DRUG

cis-atracurium 0,15 mgkg-1 intravenously (anesthesia induction)

GEN group; PVB group

Fentanyl WZF DRUG

fentanyl 1,5 µgkg-1 intravenously (anesthesia induction)

GEN group; PVB group

Sevorane DRUG

sevoflurane in 1 MAC (Minimal Alveolar Concentration) - anesthesia maintenance

GEN group; PVB group

Intubation DEVICE

Intratracheal intubation with a single lumen endotracheal tube

GEN group; PVB group

Oxynorm DRUG

1 mgml-1 concentration oxycodone solution intravenously

GEN group; PVB group

Paracetamol Kabi DRUG

1g paracetamol intravenously every 6 hours

GEN group; PVB group

Ketonal DRUG

100 mg ketoprofen intravenously every 12 hours

GEN group; PVB group

Bupivacaine WZF DRUG

0,3 ml kg-1 0,5% plain bupivacaine (regional anesthesia - paravertebral blockade)

PVB group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Silesian University of Medicine: lead

Study Sites (1)

Samodzielny Publiczny Szpital Kliniczny nr 1 SUM Zabrze

Zabrze, Silesian Voivodeship, 41-800, Poland

Location

Related Publications (1)

• 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.

  PMID: 28731925 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

cisatracurium; Sevoflurane; Intubation

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Therapeutics; Investigative Techniques

Study Officials

• Hanna Misiolek, MD PhD

  Medical School of Silesia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: November 22, 2013
• First Posted: July 21, 2016
• Study Start: May 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 21, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)