Enhanced Recovery After Surgery for Emergency Caesarean Deliveries
- Conditions
- Pregnancy Related
- Interventions
- Combination Product: Enhanced recovery after surgery (ERAS)
- Registration Number
- NCT03518463
- Lead Sponsor
- Mbarara University of Science and Technology
- Brief Summary
Caesarean section (CS) constitutes a large proportion of the total surgical volume in low-income countries. This rate comes with challenges including surgical complications, shortage of beds, and consequently long waiting time for operations and high costs. These have led to the adoption of ERAS in developed countries in a bid to save costs by reducing hospital length of stay without compromising the health of the mother and her baby.
- Detailed Description
CS is the most common major surgery at Mbarara Hospital (56.2%). This rate comes with challenges including surgical complications, shortage of beds, and consequently long waiting time for operations. Enhanced recovery programs are composed of preoperative, intraoperative and postoperative strategies combined to form a multi-modal pathway. ERAS requires a multidisciplinary team of anesthetists, surgeons and nurses for successful implementation and realization of its advantages. ERAS has been seen to reduce duration of hospital stay, complications and costs. Although many of the elements of enhanced recovery after surgery are similar, it has not been tested in emergency CS and there is limited data about its applicability in low income settings like Uganda where 95% of CS are emergencies. The aim of this study was to assess the impact of ERAS protocols following emergency caesarean delivery in a low resource setting.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 160
- We included women who were ASA 1 and 2 mothers who were delivering by emergency caesarean section using spinal anesthetic technique.
- Exclusion criteria included refusal to consent, pregnancy complicated by preeclampsia, antepartum hemorrhage, malaria, gestational diabetes mellitus, physical disability that would prevent postoperative mobilization and mental illness precluding comprehension of protocols.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Enhanced recovery after surgery (ERAS) Standard care arm received; 1. IV ceftriaxone 2g or ampiclox 2g 2. Anesthetists administered IV fluids, vasopressors, and managed hypothermia based on their clinical impressions. 3. Oral feeding and breastfeeding were allowed any time after transfer to postnatal ward. 4. Urethral catheters were removed between 12-24 hours after surgery. 5. Ward nurses and obstetricians made decisions regarding treatment without study staff input or oversight. Intervention Enhanced recovery after surgery (ERAS) ERAS arm received; Preoperative:1. Intravenous (IV) cefazoline 1g 2. IV metoclopromide 10mg, dexamethasone 8mg, ranitidine 150mg Intraoperative: 1. Hyperbaric bupivacaine 10-15mg plus intrathecal morphine 100mcg 2. Adrenaline 100mcg in 500ml of ringers lactate 3. Individualized goal directed fluid therapy 4. Reinforced counseling and education 5. wound infiltration with isobaric bupivacaine 2mg/kg 6. Rectal diclofenac 100mg and misoprostol 400mcg stat Postoperative: 1. Feeding within 1 hour 2. urethral catheter removal at 6-8 hours 3. Mobilization at 8-10 hours 4. A single fixed dose combination of ibuprofen 400 mg and paracetamol 500 mg 8 hourly 5. Tablets Amoxicillin-clavulunate 850mg 12 hourly
- Primary Outcome Measures
Name Time Method Length of hospital stay Measured from surgery up to 120 hours. Length of hospital stay was measured in hours
- Secondary Outcome Measures
Name Time Method Complication rates Pain was assessed after 6 hours postoperative; PONV, pruritus and urine retention were assessed for 24 hours; headache was assessed for 1 week; wound infection, puerperal sepsis and readmission were assessed up to 30 days postoperative These included pain, PONV, headache, pruritus, urine retention, wound infection, puerperal sepsis and readmission
Trial Locations
- Locations (1)
Mbarara university of Science and Technology
🇺🇬Mbarara, Uganda