Determination of the efficacy of the Transversus Abdominis Plane (TAP) Block in the management of postoperative pain following Caesarean Section. - TAP post LSCS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-004053-20-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 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: Adult Females aged >18 years old Presenting for elective or emergent Caesarean Section 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) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patient refusal Severe Pregnancy related diseases such as Pre-Eclamsia, HELLP. 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 In hours, in patients undergoing Caesarean Section, 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 48 hours after surgery ;Secondary Objective: Secondary Measures:Sedation Postoperative Nausea and Vomiting Patient Satisfaction Tertiary Measures:Systemic absorption of Ropivacaine Effect on the stress response to surgery ;Primary end point(s): •Time to first request for supplemental analgesia (morphine) •Total Morphine usage at 4, 12, 24 and 48 hours •Visual Analog Scores (VAS, 0= no pain, 10= worst imaginable) at rest and at movement at 30 minutes and at 2, 4, 6,12 and 24 hours. •Categorical pain scores (none=0; mild = 1; moderate = 2; severe = 3) will be recorded. •Sedation scores (awake and alert=0; quietly awake= 1; asleep but easily roused = 2; deep sleep = 3) will be recorded. •Patient satisfaction will be assessed, they will be asked whether they would be interested in having regional anaesthesia for supplemental pain relief following a future operation.	—

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 In hours, in patients undergoing Caesarean Section, 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 48 hours after surgery ;Secondary Objective: Secondary Measures:Sedation Postoperative Nausea and Vomiting Patient Satisfaction Tertiary Measures:Systemic absorption of Ropivacaine Effect on the stress response to surgery ;Primary end point(s): •Time to first request for supplemental analgesia (morphine) •Total Morphine usage at 4, 12, 24 and 48 hours •Visual Analog Scores (VAS, 0= no pain, 10= worst imaginable) at rest and at movement at 30 minutes and at 2, 4, 6,12 and 24 hours. •Categorical pain scores (none=0; mild = 1; moderate = 2; severe = 3) will be recorded. •Sedation scores (awake and alert=0; quietly awake= 1; asleep but easily roused = 2; deep sleep = 3) will be recorded. •Patient satisfaction will be assessed, they will be asked whether they would be interested in having regional anaesthesia for supplemental pain relief following a future operation.

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Countries

Ireland

Outcome results

None listed

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