Thoracic Paravertebral Block in Pain Management After Renal Surgery
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| ClinicalTrials.gov Identifier: NCT02840526 |
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Recruitment Status :
Completed
First Posted : July 21, 2016
Last Update Posted : July 21, 2016
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Postoperative Pain | 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 | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 58 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Thoracic Paravertebral Block in Postoperative Pain Management After Renal Surgery |
| Study Start Date : | May 2013 |
| Actual Primary Completion Date : | December 2014 |
| Actual Study Completion Date : | December 2014 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: PVB group
Thoracic paravertebral blockade PVB (preoperatively) Bupivacaine WZF Sopodorm Propofol WZF Fentanyl WZF Nimbex Sevorane Intubation Oxynorm Ketonal Paracetamol Kabi
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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) |
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GEN group
Sopodorm Propofol WZF Fentanyl WZF Nimbex Sevorane Intubation Oxynorm Ketonal Paracetamol Kabi
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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 |
- Difference in total amount of oxycodone needed in 48 hours after surgery [ Time Frame: 48 hours postoperatively ]
- Difference in prevalence of opioid related adverse events in OBAS scale [ Time Frame: 24 hours, 48 hours after surgery ]
- Difference in pain level in VAS scale [ Time Frame: 48 hours postoperatively ]
- Difference in level of sedation assessed in Ramsay scale [ Time Frame: 48 hours after surgery ]
- Difference in patient satisfaction level assessed in Likert scale [ Time Frame: 48 hours after surgery ]
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840526
| Poland | |
| Samodzielny Publiczny Szpital Kliniczny nr 1 SUM Zabrze | |
| Zabrze, Slaskie, Poland, 41-800 | |
| Study Chair: | Hanna Misiolek, MD PhD | Medical School of Silesia |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Maja Copik, M.D., Silesian University of Medicine |
| ClinicalTrials.gov Identifier: | NCT02840526 |
| Other Study ID Numbers: |
SUM-PSK-1 |
| First Posted: | July 21, 2016 Key Record Dates |
| Last Update Posted: | July 21, 2016 |
| Last Verified: | July 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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PVB PCA nephrectomy postoperative pain |
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Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Signs and Symptoms Acetaminophen Fentanyl Bupivacaine Propofol Sevoflurane Cisatracurium Anesthetics, Local Anesthetics Central Nervous System Depressants |
Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Hypnotics and Sedatives Anesthetics, Intravenous Anesthetics, General Analgesics, Opioid Narcotics Analgesics Adjuvants, Anesthesia Analgesics, Non-Narcotic Antipyretics Platelet Aggregation Inhibitors Anesthetics, Inhalation Neuromuscular Blocking Agents |