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Postoperative PainNCT04648358

REDUCE Trial: Perineural Dexamethasone on Scalp Nerve Blocks

A study testing Bupivacaine and Dexamethasone combined with bupivacaine in people with Postoperative Pain and Craniotomy, run by Beijing Tiantan Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Pain is common in the first 2 days after major craniotomy. Inadequate analgesia may lead to an increased risk of postoperative complications. Most pain following craniotomy arises from the pericranial muscles and soft tissues of the scalp. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Postoperative Pain, Craniotomy, Dexamethasone
What is being tested?
Bupivacaine and Dexamethasone combined with bupivacaine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
156 participants
Where
1 siteChina
Study dates
13 Dec 2020to 2 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • scheduled for elective supratentorial craniotomy under general anesthesia;
  • age 18 to 64 years;
  • an American Society of Anesthesiologists (ASA) physical status of I, II or III;
  • preoperative Glasgow Coma Scale (GCS) score of 15/15.

Who cannot join

  • History of chronic headache or chronic pain syndrome of any cause, psychiatric disorders, or uncontrolled epilepsy;
  • Inability to understand or use the pain scales before surgery;
  • Excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks or 3 days per week for more than 1 month), use of drugs with confirmed or suspected sedative or analgesic effects, or use of any painkiller within 24 hours before surgery;
  • Request of oral/intravenous glucocorticoid to decrease cerebral edema within 1 week before surgery;
  • Pregnancy or breastfeeding;
  • Extreme body mass index (BMI) (< 15 or > 35);
Show all 11Show fewer
  • Participation in another interventional trial that interferes with the intervention or outcome of this trial;
  • Refusal or inability of the patient and/or legal guardian to provide informed consent;
  • Coagulopathy;
  • Infection around the puncture point;
  • History of allergies to any of the study drugs.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Tiantan Hospital

    Beijing, Beijing Municipality, 100070

Other trials in China

About this study

Official title: REDUCE Trial: The Effects of Perineural Dexamethasone on Scalp Nerve Blocks for Relief of Postcraniotomy Pain

Pain is common in the first 2 days after major craniotomy. Inadequate analgesia may lead to an increased risk of postoperative complications. Most pain following craniotomy arises from the pericranial muscles and soft tissues of the scalp. Scalp nerve blocks with local anesthesia seem to provide effective, safe, however transient postoperative analgesia which does not seem to meet the requirements of craniotomy. Currently, peripheral dexamethasone has been observed to significantly prolong the duration of analgesia of nerve blocks (e.g., saphenous nerve block, adductor canal block, thoracic paravertebral block, brachial plexus nerve block). On the contrary, a study reported that perineural dexamethasone did not appear to prolong the analgesic time after supratentorial craniotomy. However, all patients in this study were given 24 mg of oral or intravenous dexamethasone regularly at least 7 days during the perioperative period, which possibly masked the role of single local low doses of perineural dexamethasone. Therefore, the analgesic effect of single dexamethasone for scalp nerve blocks without the backdrop of perioperative glucocorticoid deserves further clarification.

Being tested
Bupivacaine, Dexamethasone combined with bupivacaine
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BupivacaineDrug

    The control group will receive scalp nerve blocks with 0.5% bupivacaine with epinephrine at 1:200,000, plus normal saline 1 ml. The anesthesiologist will perform scalp nerve blocks based on the group allocation 10 mins before the incision. Scalp nerve blocks will be performed according to the technique previously described by Pinosky et al.

  • Dexamethasone combined with bupivacaineDrug

    The DEX4mg group will receive scalp nerve blocks with 0.5% bupivacaine with epinephrine at 1:200,000, plus 4 mg dexamethasone (1 ml). The anesthesiologist will perform scalp nerve blocks based on the group allocation 10 mins before the incision. Scalp nerve blocks will be performed according to the technique previously described by Pinosky et al.

Study groups in NCT04648358
Study groupRoleWhat they receive
Control groupActive comparatorThe control group will receive scalp nerve blocks with 0.5% bupivacaine, plus normal saline with epinephrine at 1:200,000
Receives: Drug: Bupivacaine
DEX4mg groupExperimentalDEX4mg group will receive scalp nerve blocks with 0.5% bupivacaine, plus 4 mg dexamethasone with epinephrine at 1:200,000.
Receives: Drug: Dexamethasone combined with bupivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The duration of analgesia

    The time between the performance of the block and the administration of the first press the PCA demand button postoperatively.

    Measured: Within 48 hours after surgery

Secondary outcomes (9)

  1. Sufentanil consumption

    The cumulative amount of sufentanil consumption by PCA

    Measured: At 4, 12, 24 and 48 hours postoperatively

  2. Numeric rating scale (NRS)

    NRS: 11-point scale in which 0 = no pain to 10 = worst imaginable pain. An NRS score ≥4 will be considered significant or moderate pain. An NRS score ≥7 will be considered severe pain. Meanwhile, the localization of the site of the pain will also be documented.

    Measured: At 2, 4, 8, 12, 16, 20, 24, and 48 hours postoperatively

  3. Glasgow Coma Scale (GCS)

    A scale for measuring level of consciousness, in which scoring is determined by three factors: amount of eye opening, verbal responsiveness, and motor responsiveness.

    Measured: At 2, 4, 8, 12, 16, 20, 24, and 48 hours postoperatively

  4. Postoperative nausea and vomiting (PONV)

    Vomiting will be defined as the forceful expulsion of gastric contents, and nausea will be defined as an unpleasant sensation associated with the urge to vomit.

    Measured: Within 48 hours after surgery

  5. Bradycardia

    Bradycardia will be defined as HR<60 beats/minute in at least two instances more than 5 minutes apart.

    Measured: Within 48 hours after surgery

  6. Hypotension

    Hypotension will be defined as any of the following: systolic BP <90 mm Hg for 5 minutes or a 35% decrease in mean arterial blood pressure.

    Measured: Within 48 hours after surgery

  7. Emergence delirium

    Emergence delirium will be assessed by the Sedation Agitation Scale (SAS), a 7-point scale on which a higher score represents greater agitation.

    Measured: Within 48 hours after surgery

  8. The length of stay (LOS)

    The LOS will be defined as the number of nights spent in the hospital after surgery.

    Measured: About at 2 weeks after surgery

  9. Patient satisfaction score (PSS)

    PSS: 0 for unsatisfactory to 10 for very satisfactory.

    Measured: At 2, 4, 8, 12, 16, 20, 24, and 48 hours postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2020
  2. Study start13 Dec 2020
  3. Primary completion2 Jan 2023
  4. Study completion2 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
156 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04648358
Sponsor's protocol ID
KY 2018-034-02-9
Status last verified
Jan 2024
First submitted
22 Nov 2020
Last updated
25 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Flexman AM, Ng JL, Gelb AW. Acute and chronic pain following craniotomy. Curr Opin Anaesthesiol. 2010 Oct;23(5):551-7. doi: 10.1097/ACO.0b013e32833e15b9.

    PubMed 20717011

  • Dilmen OK, Akcil EF, Tunali Y, Karabulut ES, Bahar M, Altindas F, Vehid H, Yentur E. Postoperative analgesia for supratentorial craniotomy. Clin Neurol Neurosurg. 2016 Jul;146:90-5. doi: 10.1016/j.clineuro.2016.04.026. Epub 2016 May 4.

    PubMed 27164511

  • Pinosky ML, Fishman RL, Reeves ST, Harvey SC, Patel S, Palesch Y, Dorman BH. The effect of bupivacaine skull block on the hemodynamic response to craniotomy. Anesth Analg. 1996 Dec;83(6):1256-61. doi: 10.1097/00000539-199612000-00022.

    PubMed 8942596

  • Yang Y, Ou M, Zhou H, Tan L, Hu Y, Li Y, Zhu T. Effect of Scalp Nerve Block with Ropivacaine on Postoperative Pain in Patients Undergoing Craniotomy: A Randomized, Double Blinded Study. Sci Rep. 2020 Feb 13;10(1):2529. doi: 10.1038/s41598-020-59370-z.

    PubMed 32054899

  • Baloda R, Bhupal JP, Kumar P, Gandhi GS. Supraclavicular Brachial Plexus Block With or Without Dexamethasone as an Adjuvant to 0.5% Levobupivacaine: A Comparative Study. J Clin Diagn Res. 2016 Jun;10(6):UC09-12. doi: 10.7860/JCDR/2016/18325.8048. Epub 2016 Jun 1.

    PubMed 27504384

  • Jose R, Chakravarthy K, Nair S, Joseph M, Jeyaseelan V, Korula G. A Randomized Controlled Trial Studying the Role of Dexamethasone in Scalp Nerve Blocks for Supratentorial Craniotomy. J Neurosurg Anesthesiol. 2017 Apr;29(2):150-156. doi: 10.1097/ANA.0000000000000272.

    PubMed 26756502

  • Zhao C, Jia Z, Shrestha N, Luo F. REDUCE trial: the effects of perineural dexamethasone on scalp nerve blocks for relief of postcraniotomy pain-a study protocol for a randomized controlled trial. Trials. 2021 Nov 4;22(1):772. doi: 10.1186/s13063-021-05747-y.

    PubMed 34736497

Questions about this trial

What is this clinical trial studying?

A study testing Bupivacaine and Dexamethasone combined with bupivacaine in people with Postoperative Pain and Craniotomy, run by Beijing Tiantan Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The duration of analgesia (time frame: Within 48 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04648358, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.

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