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Completed

NCT Number: NCT04648358

REDUCE Trial: Perineural Dexamethasone on Scalp Nerve Blocks

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.

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Key information

Conditions

Postoperative Pain Craniotomy Dexamethasone Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Scalp Nerve Blocks Signs and Symptoms

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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);
  • 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.

Treatment and study plan

Bupivacaine

Drug

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 bupivacaine

Drug

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.

Primary outcomes

  1. The duration of analgesia

    Time frame: Within 48 hours after surgery

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

Secondary outcomes

  1. Sufentanil consumption

    Time frame: At 4, 12, 24 and 48 hours postoperatively

    The cumulative amount of sufentanil consumption by PCA

  2. Numeric rating scale (NRS)

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

    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.

  3. Glasgow Coma Scale (GCS)

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

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

  4. Postoperative nausea and vomiting (PONV)

    Time frame: Within 48 hours after surgery

    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.

  5. Bradycardia

    Time frame: Within 48 hours after surgery

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

  6. Hypotension

    Time frame: Within 48 hours after surgery

    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.

  7. Emergence delirium

    Time frame: Within 48 hours after surgery

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

  8. The length of stay (LOS)

    Time frame: About at 2 weeks after surgery

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

  9. Patient satisfaction score (PSS)

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

    PSS: 0 for unsatisfactory to 10 for very satisfactory.

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 1, 2020
Registry last updated
Jan 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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