NCT06069804

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

Beijing Tiantan Hospital·Phase 4·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Pain, Postoperative
Drug/Device/Intervention
The TR group
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Beijing Tiantan Hospital
Location
Beijing, China
Timeline & enrollment
Phase
Phase 4
Start date
Sep 25, 2023
End date
Dec 31, 2023
Enrollment
130 participants
Primary outcome

Cumulative sufentanil consumption within 48 hours postoperatively

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.

ICD-10 classifications
During surgical operationDuring surgical operationDuring surgical operationPain, unspecifiedPostoperative intestinal obstruction
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06069804
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06069804 through Pure Global AI's free database. This Phase 4 trial is sponsored by Beijing Tiantan Hospital and is currently Recruiting. The study focuses on Pain, Postoperative. Target enrollment is 130 participants.

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