Pre-emptive Scalp Infiltration With Dexamethasone Plus Ropivacaine for Post-Craniotomy Pain in Children

NCT04051723 | Completed Phase 4 DMC

• 1 other identifier: KY 2018-066-02-2
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

At present, pediatric postoperative analgesia has not been fully understood and controlled, particularly craniotomy surgery. On the one hand, professional evaluation of postoperative pain for young children is difficult; on the other hand, the particularity of craniotomy adds (such as consciousness obstacle, sleepiness, et al) disturbance to the pain assessment in children. Although opioids administration is regarded as the first-line analgesic for post-craniotomy pain management, it may be associated with delayed awakening, respiratory depression, hypercarbia and it may interfere with the neurologic examination. For the avoidance of side-effects of systemic opioids, local anesthetics administered around the incision have been performed clinically. However, some studies revealed that the analgesic effect of local anesthetics was unsatisfactory due to its short pain relief duration, steroid as adjuvant can enhance postoperative analgesia and prolong postoperative analgesia time. As is reported that postoperative pain of craniotomy is mainly caused by skin incision and reflection of muscles, preventing the liberation of inflammatory mediators around the incision seems to be more effective than simply blocking nerve conduction. Researchers have clarified that the addition of dexamethasone to local infiltration of analgesia could provide significant analgesic effects and significantly prolong the duration of analgesic effects without obvious complications for various types of surgeries. To date, no studies have evaluated the addition of dexamethasone to local infiltration for patients receiving craniotomy. Thus, investigators suppose that pre-emptive scalp infiltration with steroid (Dexamethasone) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in children.

Conditions

Pain, Postoperative; Children

Outcome Measures

Primary Outcomes (1)

• modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS)

  Postoperative pain will be estimated by using the modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS). 0 indicates no pain, 10 indicates the most severe pain imaginable.

  At 24 hours after the operation

Secondary Outcomes (14)

• modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS)

  At 2 hours, 4 hours, 8 hours, 48 hours, 72 hours, 1 week, 2 weeks after surgery

• The time to the first rescue analgesic

  Within 48 hours after the operation

• Patient satisfactory scale (PSS)

  At 2 hours, 4 hours, 8 hours, 48 hours, 72 hours, 1 week, 2 weeks after surgery

• length of stay (LOS)

  Approximately 2 weeks after the operation

• The occurrence of postoperative nausea and vomiting (PONV)

  At 2 hours, 4 hours, 8 hours, 24 hours after surgery

Study Arms (2)

The dexamethasone plus ropivacaine group

EXPERIMENTAL

Patients in the dexamethasone plus ropivacaine group will receive a peri-incisional scalp infiltration with 0.025% dexamethasone and 0.2% ropivacaine and normal saline miscible liquids.

Drug: The dexamethasone plus ropivacaine

The ropivacaine group

ACTIVE COMPARATOR

Patients in the ropivacaine group will receive a peri-incisional scalp infiltration with 0.2% ropivacaine and normal saline miscible liquids.

Drug: The ropivacaine

Interventions

The dexamethasone plus ropivacaine DRUG

The local infiltration solution containing 0.25mg Dexamethasone and 2mg ropivacaine per milliliter. The total volume is 20 ml. The assigned solution will be injected subcutaneously by surgeons along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigators.

The dexamethasone plus ropivacaine group

The ropivacaine DRUG

The local infiltration solution containing 2mg ropivacaine per milliliter. The total volume is 20 ml. The assigned solution will be injected subcutaneously by surgeons along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigators.

The ropivacaine group

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• An elective craniotomy under general anesthesia;
• American Society of Anesthesiologists (ASA) physical status of I or II;
• Participates with an anticipated fully recovery within 2 hours postoperatively;
• Informed consent by parent(s) and/or legal guardian.

You may not qualify if:

• History of allergies to any of the study drugs;
• Drugs with confirmed or suspected sedative or analgesic effects; receiving any painkiller within 24 h before surgery; children who received steroids;
• Psychiatric disorders;
• Uncontrolled epilepsy;
• Chronic headache;
• Peri-incisional infection;
• Body mass index exceeded the 99th percentile for age;
• Children who must use a patient-controlled analgesia (PCA) device;
• Children who cannot understand an instruction of pain scales before surgery.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• Beijing Children's Hospital: collaborator

Study Sites (2)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100050, China

Location

Beijing children's hospital affiliated to capital medical university

Beijing, Beijing Municipality, China

Location

Related Publications (5)

• Bronco A, Pietrini D, Lamperti M, Somaini M, Tosi F, del Lungo LM, Zeimantz E, Tumolo M, Lampugnani E, Astuto M, Perna F, Zadra N, Meneghini L, Benucci V, Bussolin L, Scolari A, Savioli A, Locatelli BG, Prussiani V, Cazzaniga M, Mazzoleni F, Giussani C, Rota M, Ferland CE, Ingelmo PM. Incidence of pain after craniotomy in children. Paediatr Anaesth. 2014 Jul;24(7):781-7. doi: 10.1111/pan.12351. Epub 2014 Jan 28.

  PMID: 24467608 BACKGROUND

• Basali A, Mascha EJ, Kalfas I, Schubert A. Relation between perioperative hypertension and intracranial hemorrhage after craniotomy. Anesthesiology. 2000 Jul;93(1):48-54. doi: 10.1097/00000542-200007000-00012.

  PMID: 10861145 BACKGROUND

• Law-Koune JD, Szekely B, Fermanian C, Peuch C, Liu N, Fischler M. Scalp infiltration with bupivacaine plus epinephrine or plain ropivacaine reduces postoperative pain after supratentorial craniotomy. J Neurosurg Anesthesiol. 2005 Jul;17(3):139-43. doi: 10.1097/01.ana.0000171730.41008.da.

  PMID: 16037734 BACKGROUND

• Ikeuchi M, Kamimoto Y, Izumi M, Fukunaga K, Aso K, Sugimura N, Yokoyama M, Tani T. Effects of dexamethasone on local infiltration analgesia in total knee arthroplasty: a randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. 2014 Jul;22(7):1638-43. doi: 10.1007/s00167-013-2367-5. Epub 2013 Jan 11.

  PMID: 23306715 BACKGROUND

• Ju NY, Cui GX, Gao W. Ropivacaine plus dexamethasone infiltration reduces postoperative pain after tonsillectomy and adenoidectomy. Int J Pediatr Otorhinolaryngol. 2013 Nov;77(11):1881-5. doi: 10.1016/j.ijporl.2013.08.037. Epub 2013 Sep 8.

  PMID: 24060088 BACKGROUND

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 Tiantan Hospital

  PRINCIPAL INVESTIGATOR

• Ming Ge, M.D.

  Beijing Children' Hospital, Capital Medical University

  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 Pain Management

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 9, 2019
• Study Start: September 2, 2019
• Primary Completion: June 5, 2020
• Study Completion: July 5, 2020
• Last Updated: July 21, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (2)