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

Study Overview
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Brief Summary
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Pain is common for the first 2 days after major craniotomy. A majority of patients would suffer from moderate-to-severe postoperative pain after undergoing craniotomy. Inadequate analgesia induced sympathetically mediated hypertension may lead to an increased risk for post-operative complications. Adequate pain control is essential for patients' prognosis and their postoperative life quality. Pain after craniotomy derives from the scalp and pericranial muscles. 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. Pain is common for the first 2 days after major elective intracranial surgery, and the relatively short analgesic time of scalp infiltration does not seem to meet the requirements of craniotomy. Steroid such as methylprednisolone as an adjuvant to local anesthetics intra-articular injected locally reduced pain intensity after total knee arthroplasty or lumbar discectomy. However, there has not been reported about local application of methylprednisolone on scalp infiltration. Thus, the investigators suppose that pre-emptive scalp infiltration with steroid (methylprednisolone) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in adults.

Official Title
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Effects of Pre-emptive Scalp Infiltration With Ropivacaine and Methylprednisolone- Ropivacaine on Pain After Craniotomy in Adults

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: The MP/RP group
* Drug: The RP group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for elective craniotomy for resection of tumour under general anaesthesia; American Society of Anesthesiologists (ASA) physical status of I , II or III; 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, methylprednisolone 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The MP/RP group<br>Participates will receive peri-incisional scalp infiltration with 10ml ropivacaine 1% wt/vol, 40mg methylprednisolone, plus 10ml saline; | Drug: The MP/RP group<br>* Miscible liquid of methylprednisolone and ropivacaine in this study will be peri-incisional scalp infiltration with 40mg methylprednisolone, 10 ml 1% ropivacaine and 10 ml normal saline miscible liquids for participants who will undergo elective craniotomy. The local infiltration solution containing 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.<br>|
| Active Comparator: The RP group<br>Participates will receive peri-incisional scalp infiltration with 10ml ropivacaine 1% wt/vol, plus 10ml saline; | Drug: The RP group<br>* Miscible liquid of ropivacaine in this study will be peri-incisional scalp infiltration with 10 ml 1% ropivacaine and 10 ml normal saline miscible liquids for participants who will undergo elective craniotomy. The local infiltration solution containing 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative butorphanol consumption within 48 hours postoperatively | All participates will receive an electronic intravenous patient-controlled analgesia (PCA) device. Participates will be advised to push the analgesic demand button if they feel pain. | Within 48 hours after the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of participants who have no butorphanol consumption | The number of participants who have not pushed the button of patient-controlled analgesia pump. | Within 48 hours after the operation | 
| The first time to press the patient-controlled analgesia button | The first time that the participants press the patient-controlled analgesia button. | Within 48 hours after the operation | 
| The total times that participants press patient-controlled analgesia button | The total times that participants press patient-controlled analgesia button including effective presses and ineffective presses. | Within 48 hours postoperatively | 
| Numerical rating scale (NRS) | Pain will be assessed after surgery by 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 | 
| Postoperative nausea and vomiting | Postoperative nausea and vomiting (PONV) was rated by participates as: 0, absent; 1, nausea not requiring treatment; 2, nausea requiring treatment; and 3, vomiting. | At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery | 
| Ramsay Sedation Scale (RSS) | 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 | 
| Respiratory depression | Respiratory depression is defined as a respiratory rate less than 10 breaths per minute or oxygen saturation was less than ninety percent. | Within 48 hours after the operation | 
| The times of emergency reducing blood pressure 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. | Within 48 hours after the operation | 
| Patient satisfactory scale (PSS) | 0 for unsatisfactory, and 10 for very satisfied | 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 | 
| The total consumption of opioids during the operation | The total consumption of opioids during the operation | During procedure | 
| The length of stay | The duration of hospitalization after the operation | Approximately 2 weeks after the surgery | 
| The World Health Organization Quality of Life (WHOQOL)-BREF | 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. | At 1 month, 3 months and 6 months after surgery | 
| Wound Healing Score | 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 1 month after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative Pain;, Post-Craniotomy;, Methylprednisolone, Ropivacaine, Scalp Infiltration