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Analgesic efficacy of ultrasound guided transversus abdominis plane block as part of a multimodal analgesic regime for post elective caesarean section pain – a comparative double-blinded placebo controlled trial using plain bupivacaine, bupivacaine with adrenaline and bupivacaine with dexamethasone. - Do adjuncts in TAP blocks prolong analgesia post caesarean section?

Analgesic efficacy of ultrasound guided transversus abdominis plane block as part of a multimodal analgesic regime for post elective caesarean section pain – a comparative double-blinded placebo controlled trial using plain bupivacaine, bupivacaine with adrenaline and bupivacaine with dexamethasone. - Do adjuncts in TAP blocks prolong analgesia post caesarean section?

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-006080-36-GB
Enrollment
Unknown
Registered
2009-01-19
Start date
2009-01-29
Completion date
Unknown
Last updated
2015-08-04

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

Conditions

This study is aimed at improving pain relief for women undergoing a planned caesarean section. Current pain relieving regimes are not ideal and often lead to women experiencing considerable pain after their operation. We would like to use local anaesthetic blocks (transversus abdominis plane blocks) to improve their pain relief. Adjuncts to the local anaesthetic may prolong and improve the quality of the analgesia. MedDRA version: 9.1 Level: LLT Classification code 10036276 Term: Postoperative

Interventions

Trade Name: Marcain 0.25% Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Perineural use Trade Name: Mar

Sponsors

Portsmouth Hospitals NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) women undergoing elective caesarean section at St Mary’s Hospital who are able to receive the standard anaesthetic and analgesic regime 2) women who are fit and well or who have only mild to moderate functional disability ( ASA 1 or 2) 3) women aged between 18 and 50 years of age 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: 1) women unable to receive the standard regime ie severe pre-eclampsia, coagulopathy, local anaesthetic allergy, non-steroidal anti-inflammatory drug intolerance 2) patients with an early pregnancy (booking) body mass index of >40 3) patients who are immunocompromised 4) patients weighing <50kg 5) patients with diabetes requiring insulin 6) patients taking any drugs with analgesic activity 7) women at the extremes of reproductive age: less than 18 years and greater than 50 years

Design outcomes

Primary

MeasureTime frame
Main Objective: To determine whether the addition of adrenaline and dexamethasone prolongs the analgesia effect of TAP blocks;Secondary Objective: To confirm that ultrasound guided TAP blocks are an effective and safe method to supplement a multi-modal analgesic technique for post caesarean section pain.;Primary end point(s): static and dynamic visual analogue pain scores at 24 hours—

Countries

United Kingdom

Outcome results

None listed

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