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Triamcinolone Acetonide as an Adjuvant to Pre-emptive Scalp Infiltration for Relief of Post-craniotomy Pain in Adults - Trial NCT06069804

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NCT06069804
Phase 4
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06069804
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Triamcinolone Acetonide as an Adjuvant to Pre-emptive Scalp Infiltration for Relief of Post-craniotomy Pain in Adults

Study Focus

Pain, Postoperative

The TR group

Interventional

drug

Sponsor & Location

Beijing Tiantan Hospital

Beijing, China

Timeline & Enrollment

Phase 4

Sep 25, 2023

Dec 31, 2023

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 operation
During surgical operation
During surgical operation
Pain, unspecified
Postoperative intestinal obstruction

Data Source

ClinicalTrials.gov

NCT06069804

Non-Device Trial