Ultrasound Guided Distal Peripheral Nerve Blocks and Postoperative Pain.
Effectiveness of Distal Peripheral Nerve Blocks on Postoperative Pain Management After Ambulatory Thumb Resection Arthroplasty.
調査の概要
詳細な説明
We designed a prospective randomized controlled trial, with nursing blinded evaluation.
We enrolled 52 patients scheduled for elective ambulatory TRA. 2 patients were excluded after randomization. Patients were randomized into two groups:
A. Group A= no distal peripheral nerve blocks (no dPNBs group; n = 24 ): We performed usual anesthetic technique for surgery: an AXILLARY BRAQUIAL PLEXUS BLOCK using SHORT ACTING local anesthetic (mepivacaine 1%). Patients allocated in this group didn't received any additional intervention in the postoperative period.
B. Group B (dPNBs group; n = 26): We performed the same anesthetic technique for surgery (AXILLARY BLOCK with 1% of mepivacaine) with an additional intervention. Patients allocated in this group received postoperatively dPNBs on target nerves. Based on surgical approached and technique we evaluated that radial and median nerves were responsible for the innervation of the surgical area, and therefore responsible for the postoperative pain. We performed dPNBs ON RADIAL AND MEDIAN NERVES (TARGET NERVES) WITH LONG ACTING AND LOW CONCENTRATION LOCAL ANESTHETIC (0,125% levobupivacaine 5ml/nerve).
All blocks were performed under ultrasound guidance.
Analgesic regime prescribed at discharge was the same in both groups: dexketoprofen with tramadol for rescue analgesia.
The primary outcome was to evaluate the proportion of patients experienced moderate to severe pain during first and second day postoperatively, mesured using a numerical visual scale (NVS) of 0 to 10 (0= no pain and 10= worst pain imaginable). We defined mild pain (NVS 0-3), moderate pain (NVS 7-10) and severe pain (NVS 7-10).
We considered dPNBs effective when patients experienced mild pain (NVS 0-3) for at least 6 hours after dPNBs puncture.
Secondary outcomes included:
- Maximum pain intensity during first and second day postoperatively.
- Duration of dPNBs, defined as the interval between dPNBs performance and the occurrence of first pain.
- Time to discharge, defined as the interval since patient arrived at postoperative care unit (PACU) until discharge home.
- Presence of distal hand motor block after dPNBs puncture.
- Needed for rescue analgesia and total consumption of tramadol during first and second day postoperatively
- Incidence of postoperative nausea and vomiting during 1st and 2nd day postoperatively
- Needed for rescue antiemetic therapy, total consumption of ondansetron and effectiveness of treatment during 1st and 2nd day postoperatively.
Patients were contacted by phone first and second day postoperatively from a blinded PACU nursing staff (all outcome data were collected by PACU nursing staff blinded to group allocation).
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Barcelona、スペイン、08025
- Hospital de La Santa Creu i Sant Pau
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age more than 18 years.
- Ambulatory TRA.
- Free acceptance to participate in the study, with informed consent signed by patient, guardian or family member.
Exclusion Criteria:
- Age less than 18 years
- Pregnancy.
- Inability to provide informed consent.
- Allergy to amide local anesthetics/NSAIDs
- Preexisting chronic pain treated with opioids.
- Neuropathy involving the extremity undergoing surgery or neurological-cognitive deficits that may interfere in the assessement.
- Contraindications to dPNBs
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：No dPNBs group
Patients in this group didn't receive any intervention in the postoperative period.
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実験的：dPNBs group
Patients in this group received ultrasound guided dPNBs on radial and median nerves (target nerves of TRA) in the postoperative period, before discharge. The procedural objective of dPNBs was to place local anesthetic around the target nerves to achieve a long lasting, sensitive and selective block in the surgical area. dPNBs were performed with 5 ml/nerve of levobupivacaine 0,125%. Ultrasound guidance allowed us to verify the correct distribution of LA around the target nerves target and optimize needle position if it was necessary, always avoiding the intraneural injection. |
In dPNBs group, we performed ultrasound guided dPNBs on radial and median nerves using low concentration and low volume of long acting local anesthetic (0.125% levobupivacaine, 5 ml per nerve).
Using low concentrations of levobupivacaine on target nerves could achieve a prolonged sensitive block in the surgical area without motor block of the hand.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of Patients Who Experienced Moderate to Severe Pain During First and Second Postoperative Day
時間枠：Up to 48 hours
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Pain scores assessed using pain numerical visual scale (NVS) of 0-10 (o= no pain and 10= worst pain imaginable).
We defined mild pain (NVS 0-3); moderate pain (NVS 4-6) and severe pain (NVS 7-10).The analysis of this variable at the end of the study will confirm or not the effectiveness of dPNBs for management of postoperative pain after TRA.
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Up to 48 hours
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Maximum Pain Intensity, Rescue Analgesia, Nausea and Vomiting Incidence, Use of Ondansetron for NVPO, Efectiveness of Ondansetron
時間枠：Up to 48 hours
|
Number of participants with Maximum pain intensity NVS > 3; Rescue analgesia; Nausea and Vomiting incidence; use of ondansetron for NVPO; Ondansetron being effective (number of participants for whom ondansetron was effective to stop NVPO).
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Up to 48 hours
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協力者と研究者
捜査官
- 主任研究者：Mireia Rodriguez, anesthesia、Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
出版物と役立つリンク
一般刊行物
- Dufeu N, Marchand-Maillet F, Atchabahian A, Robert N, Ait Yahia Y, Milan D, Robert C, Coroir M, Beaussier M. Efficacy and safety of ultrasound-guided distal blocks for analgesia without motor blockade after ambulatory hand surgery. J Hand Surg Am. 2014 Apr;39(4):737-43. doi: 10.1016/j.jhsa.2014.01.011. Epub 2014 Feb 28.
- Fredrickson MJ, Ting FS, Chinchanwala S, Boland MR. Concomitant infraclavicular plus distal median, radial, and ulnar nerve blockade accelerates upper extremity anaesthesia and improves block consistency compared with infraclavicular block alone. Br J Anaesth. 2011 Aug;107(2):236-42. doi: 10.1093/bja/aer101. Epub 2011 May 15.
- Fredrickson MJ, Wolstencroft PJ, Chinchanwala S, Boland MR. Does motor block related to long-acting brachial plexus block cause patient dissatisfaction after minor wrist and hand surgery? A randomized observer-blinded trial. Br J Anaesth. 2012 Nov;109(5):809-15. doi: 10.1093/bja/aes266. Epub 2012 Aug 2.
- Bouaziz H, Narchi P, Mercier FJ, Khoury A, Poirier T, Benhamou D. The use of a selective axillary nerve block for outpatient hand surgery. Anesth Analg. 1998 Apr;86(4):746-8. doi: 10.1097/00000539-199804000-00013.
- Vial F, Bouaziz H, Mekler G, Cornet C, Merle M, Laxenaire MC. [Postoperative pain and surgical treatment of trapeziometacarpal osteoarthritis of the thumb after ambulatory surgery]. Ann Fr Anesth Reanim. 2000 Nov;19(9):643-8. doi: 10.1016/s0750-7658(00)00292-6. French.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
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最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- IIBSP-LEV-2011-21
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