None listed
Conditions
Brief summary
A single centre double blinded randomised control trial to determine if surgical TAP blocks provide any additional post-operative analgesic benefit compared with conventional oral analgesia for caesarean sections under spinal anaesthesia with intrathecal fentanyl. 100 term pregnant women undergoing elective caesarean delivery with spinal anaesthesia (2.2mL 0.5% hyperbaric bupivacaine and 15mcg fentanyl) are to be enrolled. Patients will be randomly allocated to one of two groups of 50: they will either receive a surgical TAP block or no TAP block. In the relevant group the TAP block will be performed by the surgeon after closure of the uterus. Patient blinding will be maintained by use of the standard surgical drapes. Data collection will be carried out by the acute pain service (APS) who will also be blinded when doing follow-up assessments of pain (visual analogue 0-100mm) scores (VAS) at 2, 6, 24 and 48 hours and cumulative oxycodone use at 2, 6, 24 and 48 hours. The primary outcome will be the visual analogue scale (VAS) pain score (0-100mm) at six (6) hours post-operatively. Secondary outcomes will be: 1. Rest and dynamic visual analogue scale (VAS) pain scores (0-100mm) at 2, 6, 24 and 48 hours post-operatively. 2. Oxycodone IR use at 2, 6, 24, and 48 hours 3. Patient satisfaction scores at 24 and 48 hours (10: completely satisfied, 1: completely dissatisfied). 4. Opioid-related adverse effects including sedation, nausea, vomiting, itch and constipation over 48 hours. Sedation (assessed by the Ramsay Sedation score 1-6). The remaining side effects are graded 0-3 where 0 is none, 1 is mild with no treatment required, 2 is moderate and treatment required and helpful and 3 is severe where treatment is required and not helpful. Constipation is assessed at 48 hours only. 5. Incidence of symptoms of local anaesthetic toxicity (perioral tingling, metallic taste, tinnitus, visual disturbance, slurred speech) at 2 hours. Hypotheses 1. Surgical TAP blocks significantly reduce pain post LSCS under spinal anaesthesia as defined by reduced visual analogue scale (VAS) pain scores and oxycodone use at 2-48 hours and greater patient satisfaction scores compared to having only conventional analgesia. 2. Opioid-related adverse effects including post-operative nausea and vomiting (PONV), pruritus, sedation, constipation) by 48 hours post-operatively are reduced in the surgical TAP block groups compared to those receiving only standard care.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
Women at full term (>37 weeks) Singleton pregnancy ASA 1 or 2 Booked for elective caesarean section under spinal anaesthesia. Uncomplicated lower uterine segment caesarean section (eg. no abnormal placentation). Written informed consent 18 years or older
Exclusion criteria
ASA 3 or greater Weight<60kg or >100kg Hepatic or renal dysfunction History of chronic pain requiring more than simple analgesia Allergy/sensitivity to local anaesthetic or any other protocol medication Drug or alcohol abuse Caesarean section under general anaesthesia Failure of spinal anaesthesia Emergency caesarean section Signs or symptoms of labour Non-English speaking or inability to easily respond appropriately and independently to the post-operative questioning. Caesarean section anticipated to be greater than 1.5 hours duration. Complicated caesarean section e.g. requiring hysterectomy Post-partum haemorrhage requiring further medical or surgical intervention Localised infection at Pfannenstiel wound Withdrawal of participant from the study