Determination of the efficacy of the Transversus Abdominis Plane (TAP) Block in the management of postoperative pain following Total Abdominal Hysterectomy (TAH). - TAP post TAH

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-004049-41-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

Post operative pain following Total Abdominal Hysterectomy. 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 Other descriptive name: Local Anaesthetic Concentration unit: % percent Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult Females aged >18 years old Presenting for elective Total Abdominal Hysterectomy Written Informed Consent ASA Grade 1 to 3 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patient 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 . These neural afferents course through the neurofascial plane between the internal oblique and the transversus abdominus muscles . Based on anatomic studies, our group has identified the lumbar triangle of Petit as a potential access point to this neurofascial plane. In this study, we aim to determine the analgesic efficacy of TAP blockade in the first 48 postoperative hours, in patients undergoing TAH, in a randomized controlled double blind clinical trial.;Secondary Objective: Sedation Postoperative Nausea and Vomiting Patient Satisfaction Systemic absorption of Ropivacaine Effect on the stress response to surgery ;Primary end point(s): Primary Measures:Severity of Postoperative Pain [VAS and Categorical pain Scales] Total opiate usage in the first 48 hours after surgery Secondary Measures:Sedation Postoperative Nausea and Vomiting Patient Satisfaction Tertiary Measures:Systemic absorption of Ropivacaine Effect on the stress response to surgery	—

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 . These neural afferents course through the neurofascial plane between the internal oblique and the transversus abdominus muscles . Based on anatomic studies, our group has identified the lumbar triangle of Petit as a potential access point to this neurofascial plane. In this study, we aim to determine the analgesic efficacy of TAP blockade in the first 48 postoperative hours, in patients undergoing TAH, in a randomized controlled double blind clinical trial.;Secondary Objective: Sedation Postoperative Nausea and Vomiting Patient Satisfaction Systemic absorption of Ropivacaine Effect on the stress response to surgery ;Primary end point(s): Primary Measures:Severity of Postoperative Pain [VAS and Categorical pain Scales] Total opiate usage in the first 48 hours after surgery Secondary Measures:Sedation Postoperative Nausea and Vomiting Patient Satisfaction Tertiary Measures:Systemic absorption of Ropivacaine Effect on the stress response to surgery

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Countries

Ireland

Outcome results

None listed

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