Thoracic Paravertebral Block in Pain Management After Renal Surgery

Thoracic Paravertebral Block in Postoperative Pain Management After Renal Surgery

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Slaskie
    • Zabrze, Slaskie, Poland, 41-800
      • Samodzielny Publiczny Szpital Kliniczny nr 1 SUM Zabrze

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PVB group; Thoracic paravertebral blockade PVB (preoperatively) Bupivacaine WZF Sopodorm Propofol WZF Fentanyl WZF Nimbex Sevorane Intubation Oxynorm Ketonal Paracetamol Kabi	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)
Other: GEN group; Sopodorm Propofol WZF Fentanyl WZF Nimbex Sevorane Intubation Oxynorm Ketonal Paracetamol Kabi	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Difference in total amount of oxycodone needed in 48 hours after surgery	48 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Silesian University of Medicine
• Investigators: Study Chair: Hanna Misiolek, MD PhD, Medical School of Silesia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: November 22, 2013
• First Submitted That Met QC Criteria: July 18, 2016
• First Posted (Estimate): July 21, 2016

Study Record Updates

• Last Update Posted (Estimate): July 21, 2016
• Last Update Submitted That Met QC Criteria: July 18, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: PCA; postoperative pain; nephrectomy; PVB
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Platelet Aggregation Inhibitors; Antipyretics; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anesthetics, Local; Anesthetics, Inhalation; Fentanyl; Propofol; Acetaminophen; Sevoflurane; Bupivacaine
• Other Study ID Numbers: SUM-PSK-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No