Scalp Infiltration With Dexamethasone Plus Ropivacaine for Post-craniotomy Pain

NCT04488315 | Unknown Phase 4 DMC

• 1 other identifier: KY-2018-034-02-8
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

According to recent studies, patients following craniotomy suffer more than minimal pain; two-thirds of patients experienced moderate to severe pain. Postoperative pain most often occurs within 48 hours after surgery. Local infiltration of anesthesia is the most simple and effective analgesia. However, the analgesic effect only lasts for a short-time after surgery, and it cannot adequately meet the needs of postoperative analgesia after craniotomy. Several studies have shown that the mixture of dexamethasone with local anesthetics could reduce the postoperative pain scores better than local anesthetics alone. Lipid microsphere is a relatively new drug delivery system. It is an artificial lipid emulsion. Studies have shown that dexamethasone lipid microsphere, the dexamethasone palmitate emulsion (D-PAL emulsion), has stronger anti-inflammatory effect than dexamethasone. Therefore, the investigators hypothesize that the pre-emptive scalp infiltration with dexamethasone lipid microsphere plus ropivacaine could achieve superior postoperative pain-relief compared to ropivacaine alone for patients undergoing craniotomy.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• The pain NRS scores at 24 h after craniotomy

  The numeral rating scale allows a person to describe the intensity of the pain as a number usually ranging from 0 to 10, where "0" means "no pain" and "10" means pain as "bad as it could be".

  At 24 hours after the operation

Secondary Outcomes (12)

• The first time the patients press the PCA button

  Within 24, 48,72 hours postoperatively

• The number of patients who didn't press the PCA button

  Within 24, 48, 72 hours postoperatively

• The number of times patients press the PCA button

  Within 24, 48, 72 hours postoperatively

• The NRS score

  At 2 hours, 4 hours, 12 hours, 48 hours, 72 hours, 1 month, and 3 months after the operation

• The incidence of PONV

  Within 24, 48, 72 hours after surgery

Study Arms (2)

The dexamethasone lipid microsphere plus ropivacaine group

EXPERIMENTAL

Drug: Dexamethasone lipid microsphere plus ropivacaine

The ropivacaine alone group

ACTIVE COMPARATOR

Drug: Ropivacaine alone

Interventions

Dexamethasone lipid microsphere plus ropivacaine DRUG

Local scalp infiltration solution will consist of 30ml miscible liquids containing 8 mg dexamethasone lipid microsphere, 150mg ropivacaine and normal saline.

Also known as: ropivacaine plus D-PAL

The dexamethasone lipid microsphere plus ropivacaine group

Ropivacaine alone DRUG

Local scalp infiltration solution will consist of 30ml miscible liquids containing 150mg ropivacaine and normal saline

The ropivacaine alone group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients scheduled for elective craniotomy under general anesthesia;
• Age 18-64 years;
• American Society of Anesthesiologists (ASA) physical status of I or II;
• Anticipated tracheal extubation, full recovery and cooperation within 2 hours postoperatively
• Patients required to fix their head in a head clamp during the operation.

You may not qualify if:

• Previous history of craniotomy;
• Plan to delay extubation or no plan to extubate;
• Patients who cannot use the patient-controlled analgesia (PCA) device;
• Patients who cannot comprehend the instructions of a numeric rating scale (NRS) before craniotomy;
• Body mass index (BMI) \<15 or \>35;
• Allergy to dexamethasone, lipid microsphere, opioids or ropivacaine;
• History of drug abuse or excessive alcohol, chronic opioids use (more than 2 weeks), or use of any sedative or analgesic before surgery;
• History of uncontrolled epilepsy, psychiatric disorders or chronic headache;
• Pregnant or at breastfeeding;
• Symptomatic cardiopulmonary, liver or renal dysfunction or combined with diabetes or other systemic dysfunction;
• Glasgow Coma Scale \<15 before the surgery;
• Intracranial hypertension;
• Peri-incisional infection;
• Patients who have received chemoradiotherapy before the surgery or expected to receive postoperative chemoradiotherapy according to the preoperative imaging.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

Location

Related Publications (4)

• Zhou H, Ou M, Yang Y, Ruan Q, Pan Y, Li Y. Effect of skin infiltration with ropivacaine on postoperative pain in patients undergoing craniotomy. Springerplus. 2016 Jul 26;5(1):1180. doi: 10.1186/s40064-016-2856-3. eCollection 2016.

  PMID: 27512639 BACKGROUND

• Gottschalk A, Berkow LC, Stevens RD, Mirski M, Thompson RE, White ED, Weingart JD, Long DM, Yaster M. Prospective evaluation of pain and analgesic use following major elective intracranial surgery. J Neurosurg. 2007 Feb;106(2):210-6. doi: 10.3171/jns.2007.106.2.210.

  PMID: 17410701 BACKGROUND

• Jia Y, Zhao C, Ren H, Wang T, Luo F. Pre-emptive scalp infiltration with dexamethasone plus ropivacaine for postoperative pain after craniotomy: a protocol for a prospective, randomized controlled trial. J Pain Res. 2019 May 24;12:1709-1719. doi: 10.2147/JPR.S190679. eCollection 2019.

  PMID: 31213883 BACKGROUND

• Zhang W, Li C, Zhao C, Ji N, Luo F. Pre-incisional infiltration with ropivacaine plus dexamethasone palmitate emulsion for postoperative pain in patients undergoing craniotomy: study protocol for a prospective, randomized controlled trial. Trials. 2022 Dec 12;23(1):996. doi: 10.1186/s13063-022-06936-z.

  PMID: 36510271 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Fang Luo, M.D.

  Beijing Tian Hospital

  PRINCIPAL INVESTIGATOR

• Wei Zhang, MD

  Beijing Tian Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Day Surgery and Pain Management

Study Record Dates

• First Submitted: July 19, 2020
• First Posted: July 28, 2020
• Study Start: October 1, 2022
• Primary Completion: September 26, 2023
• Study Completion: December 25, 2023
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)