Avoid With Locoregional Analgesia Persistant Postoperative Pain In Children

Persistent Postoperative Pain Clinical Trial

— AWA3PASIC  

Official title:

Impact Evaluation of Perioperative Locoregional Analgesia on Persistent Postoperative Pain in Children After Orthopedic Surgery for Traumatology : a Prospective, Single Center, Randomised Controlled Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06271174
• Other study ID #: RC23_0009
• Status: Recruiting
• Phase: Phase 3
• Start date: June 6, 2024
• Est. completion date: June 2026

Study information

• Verified date: June 2024
• Source: Nantes University Hospital
• Contact: Rémi Bernardon
• Phone: +33(0)2 43 48 22 15
• Email: remi.bernardon[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Persistent postoperative pain is a substantial pain (scores 4-10 using a 0-10 numeric scale) that develops 3 months after surgery.

Persistent postoperative pain can be a problem even in ambulatory surgery. Loco-regional analgesia could prevent the occurrence of this pathology but contradictory results are found in ancient studies.

This study is the first randomized controlled study in children about loco-regional analgesia and persistent postoperative pain in traumatologic orthopedic surgery.

One interventional arm will receive a locoregional analgesia after general anesthesia and before incision. The other arm will only receive systemic analgesia during general anesthesia.

The incidence of persistent postoperative pain at 3, 6 and 12 months will be compared in these two groups.

The goal is to show the decrease of the incidence of the persistent postoperative pain in the group "locoregional analgesia".

Description:

Patients between 5 years old and 15 years, 3 months old operated for a traumatologic orthopedic surgery in CHU Nantes will be included in this study.

Patients between 5 years old and 15 years, 3 months old operated for a traumatologic orthopedic surgery in CHU Nantes will be included in this study.

They will be randomized in two groups. General anesthesia will be administered in both groups.

One arm will receive a locoregional analgesia guiding by echography before incision with a local anesthetic (Carbocaïne) and a systemic analgesia if necessary. One arm will only receive a systemic analgesia.

The drugs used for general anesthesia and systemic analgesia will be standardized in the two groups.

The incidence of persistent postoperative pain at 3, 6 and 12 months will be compared in both arms. A screening of a neuropathic pain will be realized if a pain exists.

The consumption of opioids the first 24 postoperative hours, the time spent in the post interventional care unit and the incidence of nausea, vomiting will also be compared.

The goal is to show the decrease of the incidence of the persistent postoperative pain and a better recovery in the post interventional care unit in the group "locoregional analgesia".

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 208
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 183 Months

Eligibility

Inclusion Criteria:

• Age between 5 years old and 15 years and 3 months

• Traumatologic orthopedic surgery in CHU Nantes

• Conscious patient (Glasgow score =15)

• Patients able to give a verbal assessment of their pain

• No contraindication to Locoregional Analgesia

• Patient member of the social security system

• Oral consent of the patient

• Signed consent of one of the two holders of parental authority

Exclusion Criteria:

• Refusal to participate of the patient or one of the two holders of parental authority

• Neurologic deficit of the operated limb before intervention

• Ischemia of the operated limb before intervention

• Polytraumatized patient

• Allergia to Carbocaïne

• Atrioventricular conduction disorders

• Patient included in an other study about analgesia

• Anticoagulant treatment

• Uncontrolled epilepsy despite treatment

• Porphyria

Related Conditions & MeSH terms

• Pain, Postoperative
• Persistent Postoperative Pain

Intervention

Drug:
• Carbocaine
After general anesthesia and before incision, patients will receive loco-regional analgesia. Carbocaïne will be injected around the nerve responsible of the innervation of the operated area by echography guidance.
• Profofol and/or Suxaméthonium and/or Sévoflurane
General anesthesia Anesthetic induction is performed on a full stomach using : Intravenous hypnotic Propofol 2-5 mg/kg A rapid-acting intravenous curare Suxamethonium 1 mg/kg On an empty stomach : - An intravenous hypnotic Propofol 2 to 5 mg/kg or/and an inhalatory hypnotic, Sevoflurane, as anesthetic co-induction by these 2 agents is generally used in pediatrics.

Locations

Country	Name	City	State
France	CHU Nantes	Nantes

Sponsors (2)

Lead Sponsor	Collaborator
Nantes University Hospital	Fondation Apicil

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Persistent Postoperative Pain	Numerical Scale of pain superior to 3 (0 to 10). 0 : no pain - better outcome 10 : max of pain - worse outcome	3 months after surgery
Secondary	Screening of neuropathic pain if persistent postoperative pain - 3 months	DN4 score (0 to 10) - Self-assessment scale for estimating the probability of neuropathic pain Patient score is equal to or greater than 4/10, the test is positive 0 : minimum value / better outcome 10 : maximul value / worse outcome	3 months after surgery.
Secondary	Screening of neuropathic pain if persistent postoperative pain - 6 months	DN4 score (0 to 10) - Self-assessment scale for estimating the probability of neuropathic pain Patient score is equal to or greater than 4/10, the test is positive 0 : minimum value / better outcome 10 : maximul value / worse outcome	6 months after surgery.
Secondary	Screening of neuropathic pain if persistent postoperative pain - 12 months	DN4 score (0 to ten) - Self-assessment scale for estimating the probability of neuropathic pain Patient score is equal to or greater than 4/10, the test is positive 0 : minimum value / better outcome 10 : maximul value / worse outcome	12 months after surgery.
Secondary	1st EN score in immediate post-operative ICU before morphine titration	Numerical Scale of pain (0 to 10) 0 : no pain - better outcome 10 : max of pain - worse outcome	in Post Interventional Care Unit after the surgery
Secondary	Persistent postoperative pain at 6 months.	Numerical Scale of pain (0 to 10) 0 : no pain - better outcome 10 : max of pain - worse outcome	6 months after surgery.
Secondary	Persistent postoperative pain at 12 months.	Numerical Scale of pain (0 to 10) 0 : no pain - better outcome 10 : max of pain - worse outcome	12 months after surgery.
Secondary	Postoperative nausea and vomiting	presence or absence	In Post Interventional Care Unit - after the surgery-
Secondary	Time in Post Interventional Care Unit	Evaluation in minutes.	In Post Interventional Care Unit - after the surgery -
Secondary	Opioïd dose received - Per-operative	Evaluation in milligrammes	Per-operative
Secondary	Opioïd dose received - in Post Interventional Care Unit	Evaluation in milligrammes	in Post Interventional Care Unit after the surgery-
Secondary	Opioïd dose received	Evaluation in milligrammes	during the first post-operative 24 hours in the surgery department
Secondary	Intravenous Morphine dose received in Post Interventional Care Unit	Evaluation in milligrammes	in Post Interventional Care Unit after the surgery-