Enhanced Recovery After Surgery for Emergency Caesarean Deliveries (ERAS-Mbarara)

Mbarara University of Science and Technology

Status: Completed

Conditions: Pregnancy Related

Treatments: Combination Product: Enhanced recovery after surgery (ERAS)

Study type: Interventional

Funder types: Other

Identifiers

NCT03518463

MUST 0606/2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• We included women who were ASA 1 and 2 mothers who were delivering by emergency caesarean section using spinal anesthetic technique.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups

Intervention

Experimental group

Description:

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

Treatment:

Combination Product: Enhanced recovery after surgery (ERAS)

Control

Active Comparator group

Description:

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.

Treatment:

Combination Product: Enhanced recovery after surgery (ERAS)