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Completed

NCT Number: NCT03618264

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

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing Tiantan Hospital

Beijing, 100050, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Miscible liquid of dexamethasone and ropivacaine

Drug

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.

Ropivacaine

Drug

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.

Primary outcomes

  1. Cumulative sufentanil consumption within 48 hours postoperatively

    Time frame: 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.

Secondary outcomes

  1. The number of participants who have no sufentanil consumption

    Time frame: 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.

  2. The first time to press the patient-controlled analgesia button

    Time frame: Within 48 hours after the operation

    The first time that the participants press the patient-controlled analgesia button.

  3. The total times that participants press patient-controlled analgesia button

    Time frame: Within 48 hours after the operation

    The total times that participants press patient-controlled analgesia button including effective presses and ineffective presses.

  4. Numerical rating scale of pain

    Time frame: 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).

  5. Postoperative nausea and vomiting

    Time frame: At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery

    Postoperative nausea and vomiting (PONV) was rated by participates as: 0, absent; 1, nausea not requiring treatment; 2, nausea requiring treatment; and 3, vomiting.

  6. Ramsay Sedation Scale

    Time frame: 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

  7. Respiratory depression

    Time frame: Within 48 hours after the operation

    Respiratory depression is defined as a respiratory rate less than 10 breaths per minute or oxygen saturation was less than ninety percent.

  8. Heart rate

    Time frame: 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

  9. Mean arterial pressure

    Time frame: 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

  10. The times of emergency reducing blood pressure after the operation

    Time frame: Within 48 hours after the operation

    The criteria for treatment is determined by the participant's surgeon in charge.The times of emergency reducing blood pressure will be recording by the investigator.

  11. Patient satisfactory scale (PSS)

    Time frame: At 48 hours, 1 week, 1 month, 3 months and 6 months after surgery

    0 for unsatisfactory, and 10 for very satisfied

  12. The total consumption of opioids during the operation

    Time frame: During procedure

  13. The total consumption of anaesthetic during the operation

    Time frame: During procedure

  14. The duration of hospitalization after the operation

    Time frame: Approximately 2 weeks after the operation

  15. The World Health Organization Quality of Life (WHOQOL)-BREF

    Time frame: At 1 month, 3 months and 6 months after surgery

    Quality of life will be measured using the World Health Organisation QoL-BREF (WHOQOL-BREF) questionnaire. The WHOQOL-BREF is a abbreviated version of the WHOQOL-100 assessment. WHOQOL-BREF is a self-report questionnaire that contains 26 items and addresses 4 QOL domains: physical health (7 items), psychological health (6 items), social relationships (3 items) and environment (8 items). Two other items measure overall QOL and general health. Each domain's mean score can range between 4 and 20 and a higher score indicates a higher quality of life. The mean score of items within each domain is used to calculate the domain score. A transformation method converts domain scores to a 0-100 scale.

  16. Incisional related adverse events Incisional related adverse events

    Time frame: Within 1 month after surgery

    Including delayed incisional healing, incisional infection, intracranial infection, scar healing

  17. Wound Healing Score

    Time frame: 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

  18. Patient and Observer Scar Assessment Scale

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Aug 7, 2018
Registry last updated
Feb 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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