Buprenorphine與Morphine於在脊椎融合手術後經靜脈自控式止痛的比較

Comparison of Intravenous Patient-controlled Analgesia with Buprenorphine Versus Morphine after Lumbar Spinal Fusion-- A Prospective Randomized Clinical Trial

背景：以嗎啡類藥為主的病患自控式止痛已被廣泛運用在脊椎手術後的疼痛處理，但靜脈給予嗎啡類的藥物會因使用的藥物而有不同的副作用。Buprenorphine是一種部份型的嗎啡類藥物，具有呼吸抑制少和低成癮性的優點，可能減少傳統嗎啡的副作用。因此我們進行這個隨機臨床試驗以評估脊椎術後以buprenorphine或morphine做為經靜脈自控式止痛（PCA）的療效與安全性比較。方法：五十名進行腰椎融合術的病患隨機分派到兩個不同的治療組，實驗組的PCA藥物使用buprenorphine而對照組則使用morphine。以雙盲的方式從病人轉送至恢復室開始，進行為期兩天的試驗，在手術後第6，24與48小時記錄其疼痛程度，並收集其副作用的資料。結果：每組病人各隨機分配25人。有一名實驗組的病患因暈眩而中途退出試驗。兩組在病患基本資料上並無差別，其疼痛的程度也無差異。術後六小時內，buprenorphine組在PCA累計使用藥量、PCA壓按（demand）與給藥次數（delivery）、及demand/delivery比率方面，比morphine組來得多；其餘時段內兩組沒有差異。兩組均未出現嚴重之併發症。實驗組發生搔癢的比例較少（0 與24％，P = 0.02），其他副作用則相似。結論：使用buprenorphine或morphine做為經靜脈自控式止痛藥物在脊椎手術後皆可提供適當的止痛效果。Buprenorphine除了產生搔癢的比例較少外，其他副作用產生比例則與morphine相似。Buprenorphine在經靜脈自控式止痛的效果與morphine相似，可安全有效的用在脊椎手術後的經靜脈自控式止痛。

Background: Opioid-based patient-controlled analgesia (PCA) has been used widely and effectively after spine surgery. The untoward effects of intravenous opioids could vary with the drug and dose applied. Buprenorphine, a partial opioid agonist, might be devoid of the adverse effects which the traditional opioids have. We conducted this prospective randomized clinical trial to evaluate the efficacy and safety of buprenorphine for intravenous PCA after spine surgery. Methods: Fifty patients undergoing elective lumbar spinal fusion were randomly assigned to either buprenorphine or morphine group. PCA was administered in a double-blind manner for a 2-day postoperative course. The evaluation was initiated after patients were transferred to the post-anesthetic care unit. Pain assessment with visual analog scale (VAS) at rest and after pain elicitation by sitting was carried out and recorded at 6, 24, 48 hrs after surgery. Untoward effects were also collected. Results: Twenty-five patients were randomized to each group. One patient in the buprenorphine group dropped out from the study due to dizziness. There was no difference between the groups with respect to the baseline variables. The VAS scores at rest and after elicitation of pain by sitting showed no difference between both groups. The delivered volume of buprenorphine, the numbers of demand and delivery, and the demand/delivery ratio were higher in buprenorphine than morphine group at 6 hr after surgery but were not different later. No major complications occurred in both groups. The pruritus incidence in buprenorphine group was significantly lower than in morphine group (0 vs. 24%, P = 0.02). Other adverse effects were similar in both groups. Conclusions: Both buprenorphine and morphine by intravenous PCA provided adequate pain relief after posterior lumbar spinal fusion. The incidences of side effects were similar in both groups except for pruritus which did not appear in buprenorphine group. Buprenorphine was as efficient as morphine and safe for intravenous PCA after spine surgery.