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Pre-emptive Scalp Infiltration With Dexamethasone Plus Ropivacaine for Postoperative Pain After Craniotomy

15. februar 2020 opdateret af: Fang Luo, Beijing Tiantan Hospital

Pre-emptive Scalp Infiltration With Dexamethasone Plus Ropivacaine vs. Ropivacaine for Relief of Postoperative Pain After Craniotomy in Adults

A majority of patients would suffer from moderate-to-severe postoperative pain after undergoing craniotomy. As a result, adequate pain control is essential for patients' prognosis and their postoperative life quality. Although opioids administration is regarded as the first-line analgesic for post-craniotomy pain management, it may be associated with delayed awakening, respiratory depression, hypercarbia and it may interfere with the neurologic examination. For the avoidance of side-effects of systemic opioids, local anesthetics administered around the incision have been performed clinically. However, some studies revealed that the analgesic effect of local anesthetics was not unsatisfactory due to its short pain relief duration. As is reported that postoperative pain of craniotomy is mainly caused by skin incision and reflection of muscles, preventing the liberation of inflammatory mediators around the incision seems to be more effective than simply blocking nerve conduction. Thus, Investigators suppose that pre-emptive scalp infiltration with steroid (dexamethasone) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in adults.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

140

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
      • Beijing, Kina, 100050
        • Beijing Tiantan Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 64 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patients scheduled for elective craniotomy for resection of a supratentorial tumour under general anaesthesia;
  • American Society of Anesthesiologists (ASA) physical status of I or II;
  • Participates required to fix their head in a head clamp intraoperatively;
  • Participates with an anticipated fully recovery within 2 hours postoperatively.

Exclusion Criteria:

  • History of craniotomy;
  • Expected delayed extubation or no plan to extubate;
  • Participants who cannot use a patient-controlled analgesia (PCA) device;
  • Participants who cannot understand the instructions of a numeral rating scale (NRS) 35 before surgery;
  • Extreme body mass index (BMI) (< 15 or > 35);
  • Allergy to opioids, dexamethasone or ropivacaine;
  • History of excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks), or use of drugs with confirmed or suspected sedative or analgesic effects;
  • History of psychiatric disorders, uncontrolled epilepsy or chronic headache;
  • Pregnant or at breastfeeding;
  • Symptomatic cardiopulmonary, renal, or liver dysfunction or history of diabetes;
  • Preoperative Glasgow Coma Scale< 15;
  • Suspicion of intracranial hypertension;
  • Peri-incisional infection;
  • Participants who have received radiation therapy and chemotherapy preoperatively or with a high probability to require a postoperative radiation therapy and chemotherapy according to the preoperative imaging.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Dexamethasone plus Ropivacaine group
Participates received peri-incisional scalp infiltration of a miscible liquid of dexamethasone and ropivacaine. The local infiltration miscible liquid containing 0.33mg dexamethasone and 5mg ropivacaine per milliliter
Medicin: Miscible liquid of dexamethasone and ropivacaine
Intervention in this study will be peri-incisional scalp infiltration with dexamethasone, ropivacaine and normal saline miscible liquids for participants who will undergo elective craniotomy. The local infiltration solution containing 0.33mg dexamethasone and 5mg ropivacaine per milliliter will be infiltrated along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigator.
Aktiv komparator: Ropivacaine group
Participates received peri-incisional scalp infiltration of 5mg/mL ropivacaine.
Medicin: Ropivacaine
Intervention in this study will be peri-incisional scalp infiltration with ropivacaine for participants who will undergo elective craniotomy. The local infiltration solution containing 5mg ropivacaine per milliliter will be infiltrated along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigator.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cumulative sufentanil consumption within 48 hours postoperatively
Tidsramme: Within 48 hours after the operation
All participates will receive an electronic intravenous patient-controlled analgesia (PCA) device in which the bolus dose of sufentanil will be set as 2 μg with a lockout interval of 10 min and the maximum dose will be limited as 8 μg per hour. If the participates feel inadequate analgesia after 5 times of sufentanil bolus, the bolus dose will be increased to 3 μg and the maximum dose will be increased to 12 μg per hour.
Within 48 hours after the operation

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Første gang at trykke på den patientkontrollerede analgesi-knap
Tidsramme: Inden for 48 timer efter operationen
Første gang, at deltagerne trykker på den patientstyrede analgesi-knap.
Inden for 48 timer efter operationen
Postoperativ kvalme og opkastning
Tidsramme: 2 timer, 4 timer, 8 timer, 24 timer, 48 timer efter operationen
Postoperativ kvalme og opkastning (PONV) blev vurderet af deltagerne som: 0, fraværende; 1, kvalme, der ikke kræver behandling; 2, kvalme, der kræver behandling; og 3, opkastning.
2 timer, 4 timer, 8 timer, 24 timer, 48 timer efter operationen
Respirationsdepression
Tidsramme: Inden for 48 timer efter operationen
Respirationsdepression er defineret som en respirationsfrekvens på mindre end 10 vejrtrækninger i minuttet eller iltmætning var mindre end halvfems procent.
Inden for 48 timer efter operationen
Tiderne for nødsituationer, der reducerer blodtrykket efter operationen
Tidsramme: Inden for 48 timer efter operationen
Kriterierne for behandling bestemmes af deltagerens ansvarlige kirurg. Tidspunkterne for nødsænkning af blodtrykket vil blive registreret af investigator.
Inden for 48 timer efter operationen
Verdenssundhedsorganisationens livskvalitet (WHOQOL)-BREF
Tidsramme: 1 måned, 3 måneder og 6 måneder efter operationen
Livskvalitet vil blive målt ved hjælp af Verdenssundhedsorganisationens QoL-BREF (WHOQOL-BREF) spørgeskema. WHOQOL-BREF er en forkortet version af WHOQOL-100-vurderingen. WHOQOL-BREF er et selvrapporterende spørgeskema, der indeholder 26 emner og adresserer 4 QOL-domæner: fysisk sundhed (7 emner), psykologisk sundhed (6 emner), sociale relationer (3 emner) og miljø (8 emner). To andre punkter måler overordnet QOL og generel sundhed. Hvert domænes gennemsnitlige score kan variere mellem 4 og 20, og en højere score indikerer en højere livskvalitet. Den gennemsnitlige score for elementer inden for hvert domæne bruges til at beregne domænescore. En transformationsmetode konverterer domænescores til en skala fra 0-100.
1 måned, 3 måneder og 6 måneder efter operationen
Det samlede forbrug af opioider under operationen
Tidsramme: Under proceduren
Under proceduren
Det samlede forbrug af bedøvelse under operationen
Tidsramme: Under proceduren
Under proceduren
Det samlede antal gange, deltagerne trykker på patientstyret analgesi-knap
Tidsramme: Inden for 48 timer efter operationen
Det samlede antal gange, deltagerne trykker på patientkontrolleret analgesi-knap inklusive effektive tryk og ineffektive tryk.
Inden for 48 timer efter operationen
The number of participants who have no sufentanil consumption
Tidsramme: Within 48 hours after the operation
The number of participants who have not pushed the button of patient-controlled analgesia pump. Both of the initial dose and background infusion of the patient-controlled analgesia pump in this study will be set as 0. Participates will be advised to push the analgesic demand button if they feel pain.
Within 48 hours after the operation
Numerical rating scale of pain
Tidsramme: At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 1 month, 3 months and 6 months after surgery
Pain was assessed after surgery by a numerical rating scale (0 indicates no pain, 10 indicates the most severe pain imaginable).
At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 1 month, 3 months and 6 months after surgery
Ramsay Sedation Scale
Tidsramme: At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery
Ramsey 1: Anxious, agitated, restless; Ramsey 2: Cooperative, oriented, tranquil; Ramsey 3: Responsive to commands only If Asleep; Ramsey 4: Brisk response to light glabellar tap or loud auditory stimulus; Ramsey 5: Sluggish response to light glabellar tap or loud auditory stimulus; Ramsey 6: No response to light glabellar tap or loud auditory stimulus
At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery
Heart rate
Tidsramme: Before anesthesia induction, after anesthesia induction, after scalp infiltration, during skull drilling, mater cutting, skin closure and at 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery
Before anesthesia induction, after anesthesia induction, after scalp infiltration, during skull drilling, mater cutting, skin closure and at 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery
Mean arterial pressure
Tidsramme: Before anesthesia induction, after anesthesia induction, after scalp infiltration, during skull drilling, mater cutting, skin closure and at 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery
Before anesthesia induction, after anesthesia induction, after scalp infiltration, during skull drilling, mater cutting, skin closure and at 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery
Patient satisfactory scale (PSS)
Tidsramme: At 48 hours, 1 week, 1 month, 3 months and 6 months after surgery
0 for unsatisfactory, and 10 for very satisfied
At 48 hours, 1 week, 1 month, 3 months and 6 months after surgery
The duration of hospitalization after the operation
Tidsramme: Approximately 2 weeks after the operation
Approximately 2 weeks after the operation
Incisional related adverse events Incisional related adverse events
Tidsramme: Within 1 month after surgery
Including delayed incisional healing, incisional infection, intracranial infection, scar healing
Within 1 month after surgery
Wound Healing Score
Tidsramme: At 3 weeks and 6 weeks after surgery

Skin Healing

1: fully healed; 2: ≤3 cm in total not healed; 3: >3 cm not healed; 4: areas of necrosis ≤3 cm; 5: areas of necrosis >3 cm Infection

1: none; 2: ≤0.5-cm margin of redness; 3: more redness or superficial pus; 4: deep infection; not applicable Hair Regrowth

1: even regrowth along wound; 2: ≤3 cm not regrowing; 3: >3-6 cm not regrowing; 4: >6 cm not regrowing; not applicable
At 3 weeks and 6 weeks after surgery
Patient and Observer Scar Assessment Scale
Tidsramme: At 6 months after surgery
The Patient and Observer Scar Assessment Scale includes subjective symptoms of pain and pruritus and consists of 2 numerical numeric scales: The Patient Scar Assessment Scale and the Observer Scar Assessment Scale. It assesses vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion for a scar on a score of 1 (normal skin) to 10 (worst scar imaginable). and it incorporates patient assessments of pain, itching, color, stiffness, thickness, relief and overall opinion. Participants were asked to rate the severity of their scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (very different from normal skin).
At 6 months after surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Beijing Tiantan Hospital

Efterforskere

  • Ledende efterforsker: Fang Luo, MD, Beijing Tiantan Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

4. april 2019

Primær færdiggørelse (Faktiske)

15. august 2019

Studieafslutning (Faktiske)

13. februar 2020

Datoer for studieregistrering

Først indsendt

30. juli 2018

Først indsendt, der opfyldte QC-kriterier

4. august 2018

Først opslået (Faktiske)

7. august 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. februar 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. februar 2020

Sidst verificeret

1. februar 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KY 2018-034-02-1

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