NCT04073069

Scalp Infiltration With Diprospan Plus Ropivacaine for Postoperative Pain After Craniotomy in Adults

Completed Phase 4 Last updated 29 April 2022

What this trial tests

Phase 4 trial testing The DR group in Pain, Postoperative in 96 participants. Completed in 15 February 2021.

Timeline

3 September 2019

Primary endpoint
15 August 2020

15 February 2021

Quick facts

Lead sponsor	Beijing Tiantan Hospital
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	96
Start date	3 September 2019
Primary completion	15 August 2020
Estimated completion	15 February 2021
Sites	1 location across China

Drugs / interventions tested

• The DR group — full drug profile →
• The R group — full drug profile →

Conditions studied

• Pain, Postoperative — all drugs for Pain, Postoperative →
• Post-Craniotomy Headache — all drugs for Post-Craniotomy Headache →

Sponsor

Beijing Tiantan Hospital

Who can join

Adults 18 to 64, any sex, with Pain, Postoperative or Post-Craniotomy Headache. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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, such as arterial hypertension, intracranial hemorrhage, prolonged hospital stay, and mortality. 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 diprospan as an adjuvant to local anesthetics intra-articular injected locally ameliorated pain intensity in knee osteoarthritis or in total knee arthroplasty. However, there has not been reported about local application of diprospan on scalp infiltration. Thus, the investigators suppose that pre-emptive scalp infiltration with steroid (diprospan) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in adults.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.