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REDUCE Trial: Perineural Dexamethasone on Scalp Nerve Blocks

Primary Purpose

Postoperative Pain, Craniotomy, Dexamethasone

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Bupivacaine
Dexamethasone combined with bupivacaine
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Tiantan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

DEX4mg group

Arm Description

The control group will receive scalp nerve blocks with 0.5% bupivacaine, plus normal saline with epinephrine at 1:200,000

DEX4mg group will receive scalp nerve blocks with 0.5% bupivacaine, plus 4 mg dexamethasone with epinephrine at 1:200,000.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Sufentanil consumption
The cumulative amount of sufentanil consumption by PCA
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.
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.
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.
Bradycardia
Bradycardia will be defined as HR<60 beats/minute in at least two instances more than 5 minutes apart.
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.
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.
The length of stay (LOS)
The LOS will be defined as the number of nights spent in the hospital after surgery.
Patient satisfaction score (PSS)
PSS: 0 for unsatisfactory to 10 for very satisfactory.

Full Information

First Posted
November 22, 2020
Last Updated
December 25, 2020
Sponsor
Beijing Tiantan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04648358
Brief Title
REDUCE Trial: Perineural Dexamethasone on Scalp Nerve Blocks
Official Title
REDUCE Trial: The Effects of Perineural Dexamethasone on Scalp Nerve Blocks for Relief of Postcraniotomy Pain
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 13, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Craniotomy, Dexamethasone, Scalp Nerve Blocks

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The control group will receive scalp nerve blocks with 0.5% bupivacaine, plus normal saline with epinephrine at 1:200,000
Arm Title
DEX4mg group
Arm Type
Experimental
Arm Description
DEX4mg group will receive scalp nerve blocks with 0.5% bupivacaine, plus 4 mg dexamethasone with epinephrine at 1:200,000.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone combined with bupivacaine
Intervention Description
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 Outcome Measure Information:
Title
The duration of analgesia
Description
The time between the performance of the block and the administration of the first press the PCA demand button postoperatively.
Time Frame
Within 48 hours after surgery
Secondary Outcome Measure Information:
Title
Sufentanil consumption
Description
The cumulative amount of sufentanil consumption by PCA
Time Frame
At 4, 12, 24 and 48 hours postoperatively
Title
Numeric rating scale (NRS)
Description
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.
Time Frame
At 2, 4, 8, 12, 16, 20, 24, and 48 hours postoperatively
Title
Glasgow Coma Scale (GCS)
Description
A scale for measuring level of consciousness, in which scoring is determined by three factors: amount of eye opening, verbal responsiveness, and motor responsiveness.
Time Frame
At 2, 4, 8, 12, 16, 20, 24, and 48 hours postoperatively
Title
Postoperative nausea and vomiting (PONV)
Description
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.
Time Frame
Within 48 hours after surgery
Title
Bradycardia
Description
Bradycardia will be defined as HR<60 beats/minute in at least two instances more than 5 minutes apart.
Time Frame
Within 48 hours after surgery
Title
Hypotension
Description
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.
Time Frame
Within 48 hours after surgery
Title
Emergence delirium
Description
Emergence delirium will be assessed by the Sedation Agitation Scale (SAS), a 7-point scale on which a higher score represents greater agitation.
Time Frame
Within 48 hours after surgery
Title
The length of stay (LOS)
Description
The LOS will be defined as the number of nights spent in the hospital after surgery.
Time Frame
About at 2 weeks after surgery
Title
Patient satisfaction score (PSS)
Description
PSS: 0 for unsatisfactory to 10 for very satisfactory.
Time Frame
At 2, 4, 8, 12, 16, 20, 24, and 48 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fang Luo
Phone
010-59976664
Email
13611326978@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chunmei Zhao
Phone
010-59976664
Email
zhaochunmei1206@163.com
Facility Information:
Facility Name
Beijing Tiantan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100070
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fang Luo, M.D.
Phone
+86 13611326978
Email
13211326978@163.com
First Name & Middle Initial & Last Name & Degree
Fang Luo, M.D.

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
20717011
Citation
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.
Results Reference
background
PubMed Identifier
27164511
Citation
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.
Results Reference
background
PubMed Identifier
8942596
Citation
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.
Results Reference
background
PubMed Identifier
32054899
Citation
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.
Results Reference
background
PubMed Identifier
27504384
Citation
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.
Results Reference
background
PubMed Identifier
26756502
Citation
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.
Results Reference
background
PubMed Identifier
34736497
Citation
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.
Results Reference
derived

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REDUCE Trial: Perineural Dexamethasone on Scalp Nerve Blocks

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