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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04051723
• Other study ID #: KY 2018-066-02-2
• Status: Completed
• Phase: Phase 4
• Start date: September 2, 2019
• Est. completion date: July 5, 2020

Study information

• Verified date: July 2020
• Source: Beijing Tiantan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 5, 2020
• Est. primary completion date: June 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Children
• Pain, Postoperative

Intervention

Drug:
• The dexamethasone plus ropivacaine
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 ropivacaine
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.

Locations

Country	Name	City	State
China	Beijing children's hospital affiliated to capital medical university	Beijing	Beijing
China	Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital	Beijing Children's Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

Basali A, Mascha EJ, Kalfas I, Schubert A. Relation between perioperative hypertension and intracranial hemorrhage after craniotomy. Anesthesiology. 2000 Jul;93(1):48-54. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 2 hours, 4 hours, 8 hours, 48 hours, 72 hours, 1 week, 2 weeks after surgery
Secondary	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.	Within 48 hours after the operation
Secondary	Patient satisfactory scale (PSS)	0 for unsatisfactory, and 10 for very satisfied	At 2 hours, 4 hours, 8 hours, 48 hours, 72 hours, 1 week, 2 weeks after surgery
Secondary	length of stay (LOS)	LOS will be recorded as the number of nights spent in hospital after surgery.	Approximately 2 weeks after the operation
Secondary	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.	At 2 hours, 4 hours, 8 hours, 24 hours after surgery
Secondary	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.	At 2 hours, 4 hours, 8 hours, 24 hours after surgery
Secondary	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.	Within 48 hours after the operation
Secondary	Heart rate		During the operation and at 2 hours, 4 hours, 8 hours, 24 hours after surgery
Secondary	Mean arterial pressure		During the operation and at 2 hours, 4 hours, 8 hours, 24 hours after surgery
Secondary	The total consumption of opioids during the operation		During procedure
Secondary	The total consumption of anaesthetic during the operation		During procedure
Secondary	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	At 1 month after surgery
Secondary	Incisional related adverse events	Incisional related adverse events Including delayed incisional healing, incisional infection, intracranial infection, scar healing.	Approximately 2 weeks after the operation
Secondary	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.	Within 2 weeks after the operation