Unique ID issued by UMIN | UMIN000022970 |
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Receipt number | R000026426 |
Scientific Title | Effect of pregabalin combined with NSAIDs and thoracic epidural analgesia on pain after thoracotomy in lung cancer |
Date of disclosure of the study information | 2016/07/01 |
Last modified on | 2016/07/01 15:54:17 |
Effect of pregabalin combined with NSAIDs and thoracic epidural analgesia on pain after thoracotomy in lung cancer
Effect of pregabalin after thoracotomy
Effect of pregabalin combined with NSAIDs and thoracic epidural analgesia on pain after thoracotomy in lung cancer
Effect of pregabalin after thoracotomy
Japan |
lung cancer
Surgery in general | Chest surgery | Adult |
Malignancy
NO
The aim of this prospective and randomized study was to assess the analgesic efficacy, adverse effects and clinical value of pregabalin with NSAIDs and thoracic epidural analgesia (TEA), comparing to the pain management without pregabalin in post-operative thoracotomy-relating pain.
Efficacy
Confirmatory
Pragmatic
Phase II
Pain score (NRS) after removing the thoracic epidural analgesia (TEA)
Daily pain score
Times of oatient Controlled analgesia (PCA) injection of thoracic epidural analgesia
Pain scale in the morning, evening and sleeping
Occurrence rate and severity of adverse effects
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
2
Treatment
Medicine |
An epidural catheter was inserted at the T4-T5 interspace in the operating room just before starting the general anesthesia. An epidural test dose of 3mL lidocaine 10mg/mL, 5 mL ropivacaine 7.5 mg/mL was administered epidurally before the induction of general anaesthesia, followed by a continuous infusion of 5 mL/hr during surgery. An additional bolus of 5 mL ropivacaine 7.5 mg/mL was injected during chest closure. General anaesthesia was induced and maintained with an i.v. infusion of 0.2 microgram/kg/min remifentanil and a target-controlled infusion of propofol. Postoperative analgesia was provided to all patients with a patient-controlled epidural analgesia (PCEA) pump using a combination of ropivacaine 2 mg/mL and fentanyl 10 microgram/mL by continuous infusion at 4 mL/hr, bolus 3 mL, and lockout interval 20min. PCEA was maintained until the moning of the third post-operative day. Patients in the both groups were given 60 mg three times a day oral loxoprofen (Loxonin, Daiichi Sankyo Inc., Tokyo, Japan) from the lung on the first post-operative day. In the cases of inadequate analgesia (pain score at rest >5 on the numerical rating scale: NRS), 60 mg oral loxoprofen or 25mg suppository diclofenac was administered as rescue medication.
An epidural catheter was inserted at the T4-T5 interspace in the operating room just before starting the general anesthesia. An epidural test dose of 3mL lidocaine 10mg/mL, 5 mL ropivacaine 7.5 mg/mL was administered epidurally before the induction of general anaesthesia, followed by a continuous infusion of 5 mL/hr during surgery. An additional bolus of 5 mL ropivacaine 7.5 mg/mL was injected during chest closure. General anaesthesia was induced and maintained with an i.v. infusion of 0.2 microgram/kg/min remifentanil and a target-controlled infusion of propofol. Postoperative analgesia was provided to all patients with a patient-controlled epidural analgesia (PCEA) pump using a combination of ropivacaine 2 mg/mL and fentanyl 10 microgram/mL by continuous infusion at 4 mL/hr, bolus 3 mL, and lockout interval 20min. PCEA was maintained until the moning of the third post-operative day. Patients in the both groups were given 60 mg three times a day oral loxoprofen (Loxonin, Daiichi Sankyo Inc., Tokyo, Japan) from the lung on the first post-operative day. In the cases of inadequate analgesia (pain score at rest >5 on the numerical rating scale: NRS), 60 mg oral loxoprofen or 25mg suppository diclofenac was administered as rescue medication.
The patients in pregabalin, NSAIDs and TEA group were given 75 mg pregabalin at the noon and the evening on the first post-operative day, and 150 mg pregabalin three times a day after meals since the second post-operative day.The patients in pregabalin, NSAIDs and TEA group were given 75 mg pregabalin at the noon and the evening on the first post-operative day, and 150 mg pregabalin three times a day after meals since the second post-operative day.
20 | years-old | <= |
80 | years-old | >= |
Male and Female
lung cancer patients who can undergo lobectomy and pneumonectomy, and who epidural catheter is inserted at the T4-T5 interspace in the operating room.
patients who have signed the consent form to participate in this study.
patients over 20 years old when participate in this study.
patients with serious complications (such as asthma, renal disease, gastric ulcer), which are contraindication of NSAIDs.
patients over P 3 (ECOG)
patients considered unsuitable for the study by a primary physician
40
1st name | |
Middle name | |
Last name | Yasoo Sugiura |
National Hospital Organization, Kanagawa National Hospital
General Thoracic Surgery
666-1 Ochiai, Hadano City, Kanagawa Japan
0463-81-1771
yasoos@hotmail.com
1st name | |
Middle name | |
Last name | Yasoo Sugiura |
National Hospital Organization, Kanagawa National Hospital
General Thoracic Surgery
666-1 Ochiai, Hadano City, Kanagawa Japan
0463-81-1771
yasoos@hotmail.com
National Hospital Organization, Kanagawa Hospital
Not applicable
Other
NO
2016 | Year | 07 | Month | 01 | Day |
Unpublished
Completed
2012 | Year | 09 | Month | 01 | Day |
2012 | Year | 09 | Month | 01 | Day |
2014 | Year | 08 | Month | 31 | Day |
2016 | Year | 07 | Month | 01 | Day |
2016 | Year | 07 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026426
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