Triamcinolone Acetonide as an Adjuvant to Pre-emptive Scalp Infiltration for Relief of Post-craniotomy Pain in Adults

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 triamcinolone acetonide as an adjuvant to local anesthetics intra-articular injected locally ameliorated pain intensity inarthroscopic knee surgery or total knee arthroplasty. However, there has not been reported about local application of triamcinolone acetonide on scalp infiltration. Thus, the investigators suppose that pre-emptive scalp infiltration with steroid (triamcinolone acetonide) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in adults.

Official Title
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Triamcinolone Acetonide as an Adjuvant to Pre-emptive Scalp Infiltration for Relief of Post-craniotomy Pain in Adults

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: The TR group
* Drug: The R 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, triamcinolone acetonide 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 TR group<br>The respective drugs to be used for incision-site infiltration were prepared by an independent study investigator in the two groups: Participates will receive peri-incisional scalp infiltration with10 mg triamcinolone acetonide, 150 mg ropivacaine diluted to a total volume of 30 mL in 0.9% saline . The concentration of ropivacaine was 0.5% in both groups. The anesthesia protocol and monitoring were standardized for all patients. Monitoring, including blood pressure (BP), heart rate (HR), 5-lead electrocardiography (ECG), peripheral oxygen saturation (SpO2) and bispectral index (BIS) were continuously performed. | Drug: The TR group<br>* Miscible liquid of triamcinolone acetonide and ropivacaine in this study will be peri-incisional scalp infiltration with 10ml ropivacaine 1% wt/vol, 0.25ml triamcinolone acetonide (40mg/ml), plus 10 ml saline miscible liquids for participants who will undergo elective craniotomy. Local infiltration of the study solution was performed by the neurosurgeon after induction of general anesthesia and intubation, once all equipment and catheters had been placed, during stable and steady state anesthetic conditions before skin incision. The solution was infiltrated with a 22-gauge needle introduced into the skin at a 45° angle throughout the entire thickness of the scalp along the planned incision site and the head-holder sites, by the same neurosurgeon. The total volume of the study solution used for each patient was determined by the neurosurgeon mainly based on the length of the incision and recorded by the investigator.<br>|
| Active Comparator: The R group<br>The respective drugs to be used for incision-site infiltration were prepared by an independent study investigator in the two groups: Participates will receive peri-incisional scalp infiltration with 150 mg ropivacaine diluted to a total volume of 30 mL in 0.9% saline in the control group. The concentration of ropivacaine was 0.5% in both groups. The anesthesia protocol and monitoring were standardized for all patients. Monitoring, including blood pressure (BP), heart rate (HR), 5-lead electrocardiography (ECG), peripheral oxygen saturation (SpO2) and bispectral index (BIS) were continuously performed. | Drug: The R group<br>* Miscible liquid of ropivacaine in this study will be peri-incisional scalp infiltration with 10ml ropivacaine 1% wt/vol, plus 10 ml saline miscible liquids for participants who will undergo elective craniotomy. Local infiltration of the study solution was performed by the neurosurgeon after induction of general anesthesia and intubation, once all equipment and catheters had been placed, during stable and steady state anesthetic conditions before skin incision. The solution was infiltrated with a 22-gauge needle introduced into the skin at a 45° angle throughout the entire thickness of the scalp along the planned incision site and the head-holder sites, by the same neurosurgeon. The total volume of the study solution used for each patient was determined by the neurosurgeon mainly based on the length of the incision and recorded by the investigator.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative sufentanil 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 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, | 
| 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 | 
| 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 | 
| 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 | 
| 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, Pre-emptive Scalp Infiltration, Ropivacaine, Triamcinolone Acetonide