Determination of the efficacy of the Transversus Abdominis Plane Block in the management of postoperative pain in children post open abdominal surgery.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-003231-71-IE

Enrollment

Registered

2006-09-20

Start date

2006-12-08

Completion date

Unknown

Last updated

2025-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative pain in children post open abdominal surgery MedDRA version: 8.1 Level: LLT Classification code 10054711 Term: Postoperative pain

Interventions

Trade Name: Naropin Pharmaceutical Form: Solution for injection INN or Proposed INN: ROPIVACAINE CAS Number: 84057954 Concentration unit: % percent Concentration type: up to Concentration number: 0.75

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Children under 18 years of age Presenting for elective or emergent abdominal surgery Written Informed Consent [Parental consent where appropriate] ASA Grade 1 to 3 Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion Criteria: Patient or Parental refusal Outside Age Range Allergy to bupivacaine, morphine, paracetamol, diclofenac sodium Skin lesions/infection at site of injection Renal or other organ dysfunction Sepsis

Design outcomes

Primary

Measure	Time frame
Main Objective: We have recently described the Transversus Abdominis Plane (TAP) Block, a reliable approach to the blockade of the neural afferents to the anterior abdominal wall.The lumbar triangle of Petit is a potential access point to this neurofascial plane. Therefore, by introducing local anesthetic agents into this space via the triangle of Petit it is possible to block the sensory nerves of the anterior abdominal wall before they pierce the musculature to innervate the abdomen. We aim to determine the analgesic efficacy of TAP blockade in the first 24 postoperative hours, in children undergoing abdominal surgery via an abdominal wall incision, in a randomized controlled double blind clinical trial. Primary Measures: Severity of Postoperative Pain [VAS and Categorical pain Scales] Total opiate usage in the first 24 hours after surgery ;Secondary Objective: Secondary Measures:Sedation Postoperative Nausea and Vomiting Systemic absorption of Bupivacaine Effect on the stress response to surgery Patient Satisfaction ;Primary end point(s): Primary Measures:Severity of Postoperative Pain [VAS and Categorical pain Scales] Total opiate usage in the first 24 hours after surgery Secondary Measures:Sedation Postoperative Nausea and Vomiting Systemic absorption of Bupivacaine Effect on the stress response to surgery Patient Satisfaction	—

Measure

Time frame

Main Objective: We have recently described the Transversus Abdominis Plane (TAP) Block, a reliable approach to the blockade of the neural afferents to the anterior abdominal wall.The lumbar triangle of Petit is a potential access point to this neurofascial plane. Therefore, by introducing local anesthetic agents into this space via the triangle of Petit it is possible to block the sensory nerves of the anterior abdominal wall before they pierce the musculature to innervate the abdomen. We aim to determine the analgesic efficacy of TAP blockade in the first 24 postoperative hours, in children undergoing abdominal surgery via an abdominal wall incision, in a randomized controlled double blind clinical trial. Primary Measures: Severity of Postoperative Pain [VAS and Categorical pain Scales] Total opiate usage in the first 24 hours after surgery ;Secondary Objective: Secondary Measures:Sedation Postoperative Nausea and Vomiting Systemic absorption of Bupivacaine Effect on the stress response to surgery Patient Satisfaction ;Primary end point(s): Primary Measures:Severity of Postoperative Pain [VAS and Categorical pain Scales] Total opiate usage in the first 24 hours after surgery Secondary Measures:Sedation Postoperative Nausea and Vomiting Systemic absorption of Bupivacaine Effect on the stress response to surgery Patient Satisfaction

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Countries

Ireland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026