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

Phase 4

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: The R group; Drug: The TR group

• Registration Number: NCT06069804
• Lead Sponsor: Beijing Tiantan Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-24
• Study First Submitted QC: 2023-09-29
• Study First Posted: 2023-10-06
• Study Start: 2023-10-07
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The R group	The R group	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.
The TR group	The TR group	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.

Primary Outcome Measures

Name	Time	Method
Cumulative sufentanil consumption within 48 hours postoperatively	Within 48 hours after the operation	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.

Secondary Outcome Measures

Name	Time	Method
The first time to press the patient-controlled analgesia button	Within 48 hours after the operation	The first time that the participants press the patient-controlled analgesia button.
The times of emergency reducing blood pressure after the operation	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.
The total consumption of opioids during the operation	During procedure	The total consumption of opioids during the operation
Postoperative nausea and vomiting	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.
The total times that participants press patient-controlled analgesia button	Within 48 hours postoperatively	The total times that participants press patient-controlled analgesia button including effective presses and ineffective presses.
Numerical rating scale (NRS)	At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 1 month,	Pain will be assessed after surgery by numerical rating scale (0 indicates no pain, 10 indicates the most severe pain imaginable).
The length of stay	Approximately 2 weeks after the surgery	The duration of hospitalization after the operation
Wound Healing Score	At 1 month 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

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China