Multimodal smärtstudie i patienter med fri klaff

Randomiserad kontrollerad prospektiv studie för att jämföra två standarder för vård för smärtbehandling av huvud- och nackkirurgi. Arm A, kommer att innehålla:

• Schemalagd Tylenol 1000 mg IV engångsdos intraoperativt, sedan 650 mg via PEG-rör eller PO Q4H till en maxdos på 4gm/24 timmar
• Opioider prn baserad på numerisk smärtskala (0-10, där 0 indikerar ingen smärta och 10 indikerar värsta smärtan någonsin):
• 0-3: ingen prn meds, lugnande, lyssna på musik, titta på TV.
• 4-7: Oxykodon 5 mg q4h prn via PEG-rör eller PO med max 30 mg/24 timmar.
• 8-10 Morfin 2 mg IV q2h prn genombrottssmärta.

Arm B, kommer att innehålla:

• Arm En beskrivning med tillägg..
• Schemalagd Ketorolac med start efter operation dag #1, 15 mg q6h (max 120 mg/dag), i totalt 5 dagar
• Schemalagd Gabapentin med start 7 dagar preoperativt för att fortsätta postoperativt
• Regionalt blockering per anestesiprotokoll - Inledande blockering: 0,5 % bupivakain, 20 ml Kontinuerlig infusion: 0,125 % bupivakain med 6 ml/timme med en 5 ml bolus tillgänglig var 30:e minut

Pain was measured on a Likert scale from 0 to 10 (i.e. 0 being the lowest and 10 being the greatest amount of pain). Baseline pain (P0) was measured on this scale for each patient in the preoperative setting. Pain was similarly assessed at regular intervals post-operatively during hospitalization (Pn).

Patient pain percentage was subsequently defined as follows:

{ 100*[(P_n/P_0) -1]│ n∈N, n≥1}

Where:

P_0: the baseline (initial) measurement taken at time t=0. P_n: the measurement taken at the nth time interval after baseline, where n∈N, n≥1

Interpretation of "pain percentage compared to baseline":

• A value of 0% indicates no change from baseline pain
• Negative values indicate lower pain than baseline
• Positive values indicate higher pain than baseline
• Therefore, lower values represent a better outcome and higher values represent a worse outcome

Each of the domain of ABC pain index is weighted (mult_D) based on relative importance.

For each domain D ∈{sleep, lying, sitting, oob, walk}, let:

D_able∈{1,2,3}, (1 = able with pain; 2 = unable due to pain; 3 = unable for other reasons) D_pain∈[0, 5] (reported pain score)

Then if:

D_able = 1 numerator_D = D_pain × mult_D denominator_D = 1 +(5×mult_D) D_able=2 numerator_D = 1 + (5×mult_D) denominator_D= 1 + (5×mult_D ) D_able=3 numerator_D = 1 denominator_D = 1

For the site-specific domains D ∈{h&n,flap,graft}, let:

D_present∈{1,2} (1=present; 2=absent) D_pain∈[0, 5] (reported pain score)

Then if:

D_present=1:

numerator_D = D_pain × mult_D denominator_D = 5 × mult_D

D_present=2:

numerator_D = 0 denominator_D = 0

Patient Pain Assessment Percentage:

ABC_numerator = sum(numerator_D) ABC_denominator = sum(denominator_D) ABC_percentage = ABC_numerator / ABC_denominator This ranges from 0-100%. Lower values are better, higher values are worse.