Thoracic Paravertebral Block in Pain Management After Renal Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PVB group

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

Group Type EXPERIMENTAL

Paravertebral blockade (PVB)

Intervention Type PROCEDURE

preoperative ThPVB performed unilaterally at Th10 level

Sopodorm

Intervention Type DRUG

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

Propofol WZF

Intervention Type DRUG

propofol 2 mgkg-1intravenously (anesthesia induction)

Nimbex

Intervention Type DRUG

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

Fentanyl WZF

Intervention Type DRUG

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

Sevorane

Intervention Type DRUG

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

Intubation

Intervention Type DEVICE

Intratracheal intubation with a single lumen endotracheal tube

Oxynorm

Intervention Type DRUG

1 mgml-1 concentration oxycodone solution intravenously

Paracetamol Kabi

Intervention Type DRUG

1g paracetamol intravenously every 6 hours

Ketonal

Intervention Type DRUG

100 mg ketoprofen intravenously every 12 hours

Bupivacaine WZF

Intervention Type DRUG

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

GEN group

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

Group Type OTHER

Sopodorm

Intervention Type DRUG

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

Propofol WZF

Intervention Type DRUG

propofol 2 mgkg-1intravenously (anesthesia induction)

Nimbex

Intervention Type DRUG

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

Fentanyl WZF

Intervention Type DRUG

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

Sevorane

Intervention Type DRUG

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

Intubation

Intervention Type DEVICE

Intratracheal intubation with a single lumen endotracheal tube

Oxynorm

Intervention Type DRUG

1 mgml-1 concentration oxycodone solution intravenously

Paracetamol Kabi

Intervention Type DRUG

1g paracetamol intravenously every 6 hours

Ketonal

Intervention Type DRUG

100 mg ketoprofen intravenously every 12 hours

Interventions

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Paravertebral blockade (PVB)

preoperative ThPVB performed unilaterally at Th10 level

Intervention Type PROCEDURE

Sopodorm

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

Intervention Type DRUG

Propofol WZF

propofol 2 mgkg-1intravenously (anesthesia induction)

Intervention Type DRUG

Nimbex

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

Intervention Type DRUG

Fentanyl WZF

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

Intervention Type DRUG

Sevorane

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

Intervention Type DRUG

Intubation

Intratracheal intubation with a single lumen endotracheal tube

Intervention Type DEVICE

Oxynorm

1 mgml-1 concentration oxycodone solution intravenously

Intervention Type DRUG

Paracetamol Kabi

1g paracetamol intravenously every 6 hours

Intervention Type DRUG

Ketonal

100 mg ketoprofen intravenously every 12 hours

Intervention Type DRUG

Bupivacaine WZF

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No