Pregnancy Related
Conditions
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.
Interventions
COMBINATION_PRODUCTEnhanced recovery after surgery (ERAS)
The ERAS arm was exposed to standard preoperative, intraoperative and postoperative ERAS protocols of care. However, some were modified to our local resources and requirements as well as to the emergency nature of the surgeries.
Sponsors
Mbarara University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Mothers delivering by emergency CS were randomly assigned to either ERAS or routine care arms in a ratio of 1:1. We did simple randomization to either ERAS or routine care arm without any blocks. We generated patient group assignments using the computer algorithm (computer-generated list of random numbers) and placed in identical sealed opaque envelopes. A statistician not involved in the research generated the random number list. The envelopes were opened sequentially by the anesthetist when an eligible patient was encountered. Mothers were recruited into the study by the two research assistants implementing ERAS elements. Single blinding of PI and the two research assistants assessing outcomes was done to minimize bias.
Intervention model description
The ERAS arm was exposed to modified ERAS elements including preoperative counseling and education, prophylaxis against nausea and vomiting (PONV), individualized goal directed fluid therapy, early mobilization at 6-8 hours postoperative, early feeding within 1 hour postoperative,urethral catheter removal at 6 hours, oral fixed combination non opioid analgesia, oral antibiotics and anti-emetics. PONV included intravenous metoclopromide and dexametasone, no ondansetron given. Patients in the control arm recovered with routine care.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | Measured from surgery up to 120 hours. | Length of hospital stay was measured in hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Uganda
Outcome results
None listed