AzTrials
AzTrials

Pain, PostoperativePhase 4NCT04051723

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

A Phase 4 study testing The dexamethasone plus ropivacaine and The ropivacaine in people with Pain, Postoperative and Children, run by Beijing Tiantan Hospital at 2 sites in China.

Completed

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

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 2 to 12 years
Conditions the study is for
Pain, Postoperative, Children
What is being tested?
The dexamethasone plus ropivacaine and The ropivacaine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
2 sitesChina
Study dates
2 Sep 2019to 5 Jul 2020
Phase
Phase 4
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 2 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 9Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Beijing Tiantan Hospital

    Beijing, Beijing Municipality, 100050

  • Beijing children's hospital affiliated to capital medical university

    Beijing, Beijing Municipality

Other trials in China

About this study

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.

Being tested
The dexamethasone plus ropivacaine, The ropivacaine
Medical subject headings
Pain, Postoperative

What participants receive

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

  • The dexamethasone plus ropivacaineDrug

    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 ropivacaineDrug

    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.

Study groups in NCT04051723
Study groupRoleWhat they receive
The dexamethasone plus ropivacaine groupExperimentalPatients 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.
Receives: Drug: The dexamethasone plus ropivacaine
The ropivacaine groupActive comparatorPatients in the ropivacaine group will receive a peri-incisional scalp infiltration with 0.2% ropivacaine and normal saline miscible liquids.
Receives: Drug: The ropivacaine

What is being measured

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

  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.

    Measured: At 24 hours after the operation

Secondary outcomes (14)

  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.

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

  2. The time to the first rescue analgesic

    Rescue analgesics will be administered if the patient exhibits signs of sympathetic stimulation in the form of undue tachycardia, a rise in mean arterial pressure (rise of >20% from the baseline), and mCHEOPS score above 5 (range 1 to 10) or if the children are in obvious pain and distress at any time point during a subjective assessment by the intensivist or parents.

    Measured: Within 48 hours after the operation

  3. Patient satisfactory scale (PSS)

    0 for unsatisfactory, and 10 for very satisfied

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

  4. length of stay (LOS)

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

    Measured: Approximately 2 weeks after the operation

  5. The occurrence of postoperative nausea and vomiting (PONV)

    PONV will be rated by participants as: 0, absent; 1, nausea not requiring treatment; 2, nausea requiring treatment; and 3, vomiting.

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

  6. Ramsay Sedation Scale (RSS)

    1: Anxious, agitated, restless; Ramsey 2: Cooperative, oriented, tranquil; Ramsey 3: Responsive to commands only If Asleep; Ramsey 4: Brisk response to light glabellar tap or loud auditory stimulus; Ramsey 5: Sluggish response to light glabellar tap or loud auditory stimulus; Ramsey 6: No response to light glabellar tap or loud auditory stimulus.

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

  7. The occurrence of respiratory depression

    Respiratory depression is defined as persistent (more than 1 minutes) oxygen desaturation 90 percent or respiratory rate less than 8 breaths per minute, or oxygen desaturation less than 94 percent along with respiratory rate less than 10 breaths per minute requiring supplemental oxygen to maintain oxygen saturation more than 94 percent in the absence of clinically obvious upper airway obstruction.

    Measured: Within 48 hours after the operation

  8. Heart rate

    Measured: During the operation and at 2 hours, 4 hours, 8 hours, 24 hours after surgery

  9. Mean arterial pressure

    Measured: During the operation and at 2 hours, 4 hours, 8 hours, 24 hours after surgery

  10. The total consumption of opioids during the operation

    Measured: During procedure

  11. The total consumption of anaesthetic during the operation

    Measured: During procedure

  12. Wound Healing Score

    Skin Healing 1: fully healed; 2: ≤3 cm in total not healed; 3: >3 cm not healed; 4: areas of necrosis ≤3 cm; 5: areas of necrosis >3 cm Infection 1: none; 2: ≤0.5-cm margin of redness; 3: more redness or superficial pus; 4: deep infection; not applicable Hair Regrowth 1: even regrowth along wound; 2: ≤3 cm not regrowing; 3: >3-6 cm not regrowing; 4: >6 cm not regrowing; not applicable

    Measured: At 1 month after surgery

  13. Incisional related adverse events

    Incisional related adverse events Including delayed incisional healing, incisional infection, intracranial infection, scar healing.

    Measured: Approximately 2 weeks after the operation

  14. The occurrence of the Adverse events (AEs) and serious adverse events (SAEs)

    An AE was defined as any untoward medical occurrence. An SAE included death, immediately life-threatening conditions, coma, in-patient hospitalisation or prolongation of existing hospitalisation.

    Measured: Within 2 weeks after the operation

Timeline

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

  1. First posted9 Aug 2019
  2. Study start2 Sep 2019
  3. Primary completion5 Jun 2020
  4. Study completion5 Jul 2020

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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04051723
Sponsor's protocol ID
KY 2018-066-02-2
Status last verified
Jul 2020
First submitted
8 Aug 2019
Last updated
21 Jul 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 24467608

  • 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.

    PubMed 10861145

  • 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.

    PubMed 16037734

  • 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.

    PubMed 23306715

  • 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.

    PubMed 24060088

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing The dexamethasone plus ropivacaine and The ropivacaine in people with Pain, Postoperative and Children, run by Beijing Tiantan Hospital at 2 sites 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 9 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 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS) (time frame: At 24 hours after the operation). 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 NCT04051723, which also lists 5 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 21 Jul 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in