Pre-emptive Scalp Infiltration With Dexamethasone Plus Ropivacaine vs. Ropivacaine for Relief of Postoperative Pain After Craniotomy in Adults
Overview
- Phase
- Phase 4
- Intervention
- Miscible liquid of dexamethasone and ropivacaine
- Conditions
- Pain, Postoperative
- Sponsor
- Beijing Tiantan Hospital
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Cumulative sufentanil consumption within 48 hours postoperatively
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Fang Luo
Director of Department of Pain Management
Beijing Tiantan Hospital
Eligibility Criteria
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;
Arms & Interventions
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
Intervention: Miscible liquid of dexamethasone and ropivacaine
Ropivacaine group
Participates received peri-incisional scalp infiltration of 5mg/mL ropivacaine.
Intervention: Ropivacaine
Outcomes
Primary Outcomes
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
- The number of participants who have no sufentanil consumption(Within 48 hours after the operation)
- The first time to press the patient-controlled analgesia button(Within 48 hours after the operation)
- The duration of hospitalization after the operation(Approximately 2 weeks after the operation)
- Postoperative nausea and vomiting(At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery)
- Mean arterial pressure(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)
- The total consumption of opioids during the operation(During procedure)
- The total consumption of anaesthetic during the operation(During procedure)
- The World Health Organization Quality of Life (WHOQOL)-BREF(At 1 month, 3 months and 6 months after surgery)
- Patient and Observer Scar Assessment Scale(At 6 months after surgery)
- Numerical rating scale of pain(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)
- Respiratory depression(Within 48 hours after the operation)
- Heart rate(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)
- The times of emergency reducing blood pressure after the operation(Within 48 hours after the operation)
- Patient satisfactory scale (PSS)(At 48 hours, 1 week, 1 month, 3 months and 6 months after surgery)
- Incisional related adverse events Incisional related adverse events(Within 1 month after surgery)
- The total times that participants press patient-controlled analgesia button(Within 48 hours after the operation)
- Ramsay Sedation Scale(At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery)
- Wound Healing Score(At 3 weeks and 6 weeks after surgery)