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?
- 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: 9.1Level: LLTClassification code 10036276Term: Postoperative analgesiaMedDRA version: 9.1Level: LLTClassification code 10024977Term: Lower segment Caesarean section
- Registration Number
- EUCTR2008-006080-36-GB
- Lead Sponsor
- Portsmouth Hospitals NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method