Clinical trial • Not applicable • Neurology|Other

Levobupivacaine for Chronic postsurgical pain (inguinal)|Inguinal hernia

Not applicable trial of Levobupivacaine for Chronic postsurgical pain (inguinal)|Inguinal hernia.

Overview

Trial Therapeutic Area
Neurology|Other
Trial Disease
Chronic postsurgical pain (inguinal)|Inguinal hernia
Trial Stage
Not applicable
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
13-05-2024
First CTIS Authorization Date
12-08-2024

Trial design

Randomised, group a: patients receiving the tap block before the surgery; group b: patients receiving the tap block after the surgery. the local anaesthetic product listed is levobupivacaine (local injection, max total dose 150 mg); specific dose and schedule per arm not specified.-controlled Not applicable trial in Spain.

Randomised
Yes
Comparator
Group A: Patients receiving the TAP block before the surgery; Group B: Patients receiving the TAP block after the surgery. The local anaesthetic product listed is LEVOBUPIVACAINE (local injection, max total dose 150 mg); specific dose and schedule per arm not specified.
Target Sample Size
70
Trial Duration For Participant
90

Eligibility

Recruits 70 No vulnerable population selected; participants must have the ability to give written informed consent..

Pregnancy Exclusion
Pregnancy or lactation
Vulnerable Population
No vulnerable population selected; participants must have the ability to give written informed consent.

Inclusion criteria

  • {"criterion_text":"- Patients over 18 years old"}
  • {"criterion_text":"- Patients scheduled to undergo open inguinal hernia mesh repair accoding to Lichtenstein technique"}
  • {"criterion_text":"- Patients with symptomatic inguinal hernia clinically confirmed or with image test"}
  • {"criterion_text":"- Ability to give written informed consent"}
  • {"criterion_text":"- Patients with clinical consideration ASA I, II or III"}

Exclusion criteria

  • {"criterion_text":"- Recurrent hernias or those requiring a different therapeutic technique"}
  • {"criterion_text":"- Urgent or complicated surgery or hernia"}
  • {"criterion_text":"- Previous chronic inguinal pain"}
  • {"criterion_text":"- Severe neuromuscular disorders"}
  • {"criterion_text":"- Pregnancy or lactation"}
  • {"criterion_text":"- Previous opioid treatment"}
  • {"criterion_text":"- Inability to understand the trial's instructions"}
  • {"criterion_text":"- Patients participating in other trials at the same time"}
  • {"criterion_text":"- Allergy to any of the drugs used"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Prevention of chronic postsurgical pain in patients udergoing open inguinal hernia mesh repair with the use of a TAP block","definition_or_measurement_approach":"Incidence of chronic postsurgical inguinal pain assessed using the sf-IPQ questionnaire three months after surgery."}

Secondary endpoints

  • {"endpoint_text":"- Decrease in the chronic use of analgesic drugs in patients undergoing open inguinal hernia mesh repair with the use of a TAP block","definition_or_measurement_approach":"Difference in use of analgesic drugs assessed three months after surgery."}

Other endpoints

  • {"endpoint_text":"- To assess the difference in inguinal pain (using the sf-IPQ questionnaire) before and after the surgery in every group","definition_or_measurement_approach":"Change in inguinal pain measured by sf-IPQ pre-surgery and at three months post-surgery."}
  • {"endpoint_text":"- To assess the difference in the use of analgesic drugs before and after the surgery in every group","definition_or_measurement_approach":"Change in analgesic drug use measured pre-surgery and at three months post-surgery."}

Recruitment

Planned Sample Size
70
Recruitment Window Months
12
Consent Approach
Written informed consent must be provided by participants; inclusion criterion requires 'Ability to give written informed consent'. No paediatric assent procedures (adults only). Consent documentation available in Spanish (translations provided).

Geography

Total Number Of Sites
1
Total Number Of Participants
70

Spain

Earliest CTIS Part Ii Submission Date
13-05-2024
Latest Decision Or Authorization Date
12-08-2024
Processing Time Days
91
Number Of Sites
1
Number Of Participants
70

Sites

Site Name
Hospital Central De La Defensa Gomez Ulla
Department Name
Servicio de Anestesiología y Renimación
Principal Investigator Name
Julio Morillas Martínez
Principal Investigator Email
julio.828@hotmail.com
Contact Person Name
Julio Morillas Martínez
Contact Person Email
julio.828@hotmail.com
Number Of Participants
70

Sponsor

Primary sponsor

Full Name
Hospital Central De La Defensa Gomez Ulla
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
LEVOBUPIVACAINE
Active Substance
Levobupivacaine
Modality
Small molecule
Routes Of Administration
LOCAL INJECTION
Route
LOCAL INJECTION
Authorisation Status
ProdAuthStatus 2
Maximum Dose
150 mg

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