Disertasi

Keamanan, Efektivitas, dan Kemamputerapan Larutan Tumescent One-per-Mil Berkadar Epinefrin Satu per Satu Juta dan Lidokain 0,2% dalam Operasi Bedah Tangan dan Ekstremitas Atas Tanpa Turniket: Studi Eksperimental dan Uji Klinis. = The Safety, Efficacy and Applicability of One-per-Mil Tumescent Solution Containing One per Million Epinephrine and 0.2% Lidocaine in Surgery for the Hand and Upper Extremity without Tourniquet: Experimental and Clinical Studies.

Rangkaian penelitian ini ditujukan untuk mengkaji alternatif operasi tanpa turniket melalui upaya untuk mengetahui efektivitas, keamanan, dan kemamputerapan larutan tumescent one-per-mil. Desain penelitian merupakan penelitian eksperimental, uji acak buta ganda dan seri kasus klinis penggunaan larutan tumescent yang mengandung epinefrin 1 : 1.000.000 dan lidokain 0,2% yang dilaksanakan di Fakultas Kedokteran Universitas Indonesia dan RS Cipto Mangunkusumo selama periode Juli 2013– Desember 2017. Penelitian pada flap inguinal tikus Sprague-Dawley dilakukan untuk mengetahui kejelasan lapangan operasi, peran vasokompresi hidrostatik, dan kesintasan flap. Uji klinis dilakukan pada subjek normal melalui suntikan pada pulpa jari untuk mengetahui masa tunda optimal melalui pengukuran SpO2; serta mengenali peran vasokompresi hidrostatik. Terapan klinis operasi sadar penuh dikawal dengan uji klinis untuk mengetahui mula dan lama kerja lidokain. Kelompok seri kasus meliputi operasi tangan dan ekstremitas atas pada kelompok anak, operasi kontraktur pascaluka bakar, operasi yang melibatkan tulang dan sendi, operasi eksisi malformasi vaskular, rekonstruksi web dengan flap, serta operasi sadar penuh. Uji statistik dilakukan dengan metode Chi-square, Wilcoxon bertingkat, uji t-independen dan berpasangan, dan ANOVA. Tingkat kemaknaan ditetapkan sebagai p < 0,05. Operasi pada flap inguinal tikus menghasilkan 63/63 lapangan operasi bebas perdarahan dengan 26/26 flap hidup walaupun diberi perlakuan iskemia sebelum disuntik. Tidak dijumpai perbedaan kesintasan flap antara teknik suntik acak dan teknik teratur. Walaupun kedua kelompok mengalami penurunan bermakna TcPO2, rerata TcPO2 pascaperlakuan iskemia kelompok tumescent lebih rendah daripada rerata kelompok kontrol. Hasil uji klinis menunjukkan rerata delta SpO2 pada kelompok epinefrin lebih besar secara bermakna daripada kelompok salin normal. Epinefrin menunjukkan masa tunda optimal 13,9 (SB 5,38) menit. Mula kerja lidokain 5 (1–9) menit dengan lama kerja 186,8 (SD 44.02) menit. Seluruh operasi pada 77 subjek bedah tangan dapat dikerjakan tanpa konversi turniket. Operasi sadar penuh efektif pada 20 dari 24 kasus. Lapangan operasi bebas perdarahan dapat dicapai sebesar 38,7%, baik pada subjek dewasa maupun anak. Epinefrin bersama-sama dengan efek vasokompresi hidrostatik efektif dalam menghasilkan lapangan operasi bebas perdarahan pada tikus. Keberhasilan hidup 100% flap yang telah diberi perlakuan iskemia sebelumnya menunjukkan keamanan larutan one-per-mil. Nilai saturasi yang menurun namun masih dalam rentang normal menunjukkan tidak terjadinya efek iskemia pada jari. Hasil studi pada tikus maupun subjek normal menunjukkan bahwa epinefrin bersama-sama dengan efek vasokompresi hidrostatik berperan dalam penurunan perfusi tanpa mengakibatkan iskemia. Masa tunda optimal efek hiperfusi selama 14 menit menjadi referensi yang relevan untuk mendukung praktik klinis masa tunggu sebelum insisi selama 7−10 menit. Selain efektif, termasuk dalam operasi sadar penuh yang berlangsung tanpa konversi turniket, hasil pengamatan teknik tumescent one-per-mil pada operasi kontraktur pascaluka bakar mematahkan paradigma bahwa operasi harus dilakukan dengan turniket. Larutan one-per-mil juga aman diterapkan pada operasi kasus pediatrik dengan tidak dijumpainya nekrosis flap maupun jari anak. Berdasarkan evaluasi luaran fungsi pada seri kasus operasi pada kontraktur luka bakar dan spaghetti wrists, teknik tumescent one-per-mil menunjukkan potensinya untuk dapat diterapkan pada kasus-kasus kompleks. Simpulan: Larutan tumescent one-per-mil aman, efektif, dan mampu terap untuk menggantikan turniket dalam operasi bedah tangan dan ekstremitas atas. Walaupun menyebabkan hipoperfusi, larutan one-per-mil tidak menyebabkan iskemia dan kematian jari. Masa tunda optimal sebelum insisi 13,9 menit, dengan mula dan lama kerja anestesi lokal masing-masing adalah 5 dan 186,8 menit.
Kata kunci: anestesia lokal; epinefrin; lidokain; sadar penuh; trauma tangan.


The study series were aimed to delineate hand and upper extremity surgery without tourniquet by studying the efficacy, safety, and applicability of the oneper-mil tumescent solution. Studies were designed as experimental studies, randomized clinical trials and clinical case series on the use of solution containing 1 : 1,000,000 epinephrine and 0.2% lidocaine. All the studies were conducted at Faculty of Medicine Universitas Indonesia and Cipto Mangunkusumo Hospital during the periode of July 2013– December 2017. Groin flaps in Sprague-Dawley rats were elevated to study the operative field clarity, the role of hydrostatic vasocompressive effect and flap survivals. Clinical trials were performed on normal subject’s fingers to know the optimal time delay by measuring SpO2, while also to delineate the role of vasocompressive effect. The practice of fully awake hand surgery was guided by clinical study to reveal the onset and duration of anaesthetic action. Case series were including grouped surgeries for the hand and upper extremity in children, post burn hand contractures, bone and joint related problems, vascular malformation, web reconstruction using flaps, and fully awake surgeries. Statistical analysis were performed using Chi-square test, Wilcoxon sign rank test, independent and pair t-test, and ANOVA. Significance was set at p < 0.05. Studies on animal revealed 63/63 bloodless operative fields and 26/26 flaps survived even after given ischemic insult before injection. The random pattern injection technique was not significantly different from systematic pattern technique. The epinephrine group showed significantly lower TcPO2 than control group, although both experienced significant decrease of TcPO2. The mean delta of SpO2 of the epinephrine group was significantly higher than control group in the clinical study. Epinephrine showed optimal time delay 13.9 (SD 5.38) minutes. The average onset and duration of lidocaine actions were 5 (1–9) and 186.8 (SD 44.02) minutes respectively. Surgery on 77 subjects was successfully performed without tourniquet conversion. Fully awake surgery was effective in 20 out of 24 cases. Overall, bloodless operative field was achieved in 38.7%. Epinephrine works together with hydrostatic vasocompressive effect in creating bloodless operative field in animal tissue. The safety was proven by the fact of 100% survival rate of flaps after surviving from ischemic insult. The decrease of SpO2, which was still within normal range, is an evidence of non-ischemic fingers. Both experimental and clinical studies showed that epinephrine and hydrostatic vasocompressive effect are responsible to create hypoperfusion without causing ischemia. The 14 minutes optimal time delay is relevant to the clinical practice of 7–10 minutes waiting time before incision. Besides its efficacy, the study outcome of one-per-mil tumescent technique to facilitate surgery on burn contracture breaks the old paradigm about surgery under tourniquet. The technique is also safe to be applied in paediatric patients as it showed no evidence of flap or finger necrosis. Based on the evaluation of functional outcome, one-per-mil tumescent technique is promising to be used in complicated surgeries. In summary, one-per-mil tumescent solution is safe, effective and clinically applicable to substitute tourniquet in surgery for the hand and upper extremity. Although causing hypoperfusion, one-per-mil solution did not cause ischemia and subsequent finger necrosis. The optimal time delay is 13.9 minutes; the onset and duration of local anaesthesia is 5 and 186.8 minutes respectively.
Keywords: epinephrine; hand injuries; lidocaine; local anesthesia; wakefulness.