Early Mobilization and No Urinary Catheter After Cesarean for Improved Post Operative Recovery: A Randomized Trial

Procedure

According to our department policy, the protocol for women undergoing a planned cesarean delivery includes prophylactic intravenous antibiotics with cefazolin 2 g given within 60 minutes of the start of surgery, together with 500-1000 mL of lactated Ringer's solution before surgery. Spinal anesthesia is then performed using 10 mg hyperbaric bupivacaine with 100 micrograms intrathecal morphine. Immediately afterward, a Foley urinary catheter is inserted into the bladder.

The surgical technique is at the discretion of the surgeon and is usually performed using the Misgav Ladach method. During the operation, the patient receives intravenous ondansetron to prevent nausea and vomiting, and phenylephrine is given to treat episodes of hypotension. Skin closure is performed using a continuous subcuticular suture. After surgery, the woman receives thromboprophylaxis according to her risk factors. Eight hours after surgery, the urinary catheter is removed and the woman gets out of bed for the first time, accompanied by a nurse, to go to the toilet or shower.

All women receive scheduled, around-the-clock analgesia during the first 24 hours: 1,000 mg intravenous paracetamol plus 400 mg ibuprofen every 8 hours, with the option to add dipyrone, tramadol, or morphine for breakthrough pain according to the VAS score. After that, pain treatment is given on request. Women are usually discharged on postoperative day 3.

A woman who agrees to participate in the study will sign an informed consent form and will be randomized to one of two groups. Women in the control group will receive the routine care described above. The intervention group will receive different perioperative care: no urinary catheter will be inserted, and the woman will be asked to void immediately before transfer to the operating room. Preoperative fluids will be limited to 200-300 mL of lactated Ringer's, and the woman will receive phenylephrine during surgery to maintain blood pressure. After surgery, the woman will get out of bed after 4 hours for her first void and to shower. All other perioperative care will be identical to the control group, including antibiotics, spinal anesthesia, pain control, and antithrombotic prophylaxis.

Randomization will be performed according to a computerized list, and allocation will be placed in an opaque, sequentially numbered envelope. After the patient signs the consent form, the envelope will be opened.

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Data collection

Demographic and obstetric data will be collected from the women's medical records. The primary outcome will be a composite outcome that includes: the QoR-15 (Quality of Recovery 15) questionnaire score completed 24 hours after delivery, the number of steps during the first 24 hours as counted by a smartwatch , and opioid consumption beyond the scheduled regimen during the first postoperative day. A positive outcome will be recorded if the participant meets 2 of the following 3 criteria:

1. QoR-15 score > 118
2. More than 454 steps per day (one standard deviation below the mean)
3. Opioid consumption during the first 24 hours after surgery (beyond the scheduled regimen)

Secondary outcomes will include the number of steps in the first 24 hours, and VAS pain scores at 2, 4, 8, 12, 24, and 48 hours. VAS scores at 4 and 8 hours will be recorded at rest and immediately after the first mobilization. Additional secondary outcomes will include inability to mobilize to the shower after the first time out of bed, patient satisfaction, use of analgesics, breastfeeding and time to first breastfeeding, intraoperative and postoperative complications, and length of hospital stay. Intraoperative complications will include bladder or bowel injury and postpartum hemorrhage. Postoperative complications will include urinary retention, need for blood transfusion, wound infection, endometritis, urinary tract infection, paralytic ileus, hematoma requiring drainage, need for repeat laparotomy, and readmission during the first two weeks after surgery.

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Sample size calculation

Assuming a composite outcome rate of 80% in the control group, and a hypothesized clinically meaningful improvement of 15% in the intervention group, with an alpha error of 5% and power of 80%, the calculated sample size is 260 participants (130 in each group).