Postoperative Pain Clinical Trial
Official title:
Scalpel Versus Diathermy for Transverse Abdominal Incision in Women Undergoing First Elective Caesarean Section: a Randomized Controlled Trial
The objective of this study will be to compare two methods of skin incisions during the first caesarean section (CS), that is scalpel and diathermy, assessing differences in blood loss during incision, incisional time, total surgery time, post-operative pain, wound healing, complications, and cosmetic outcomes.
Status | Not yet recruiting |
Enrollment | 84 |
Est. completion date | December 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Women without a history of previous cesarean section or other abdominal surgery 2. Age greater then 18 years (only adult patients) 3. Body Mass Index (BMI) between 18.5 and 29.9 kg/m2 4. Gestational age greater then 37 weeks (at term pregnancies) 5. No contraindications to spinal anesthesia 6. Indication to elective CS: extra-obstetrical reasons, failure of medical induction of labor, breech fetal presentation 7. Informed consent Exclusion Criteria: 1. Women refusing to participate in the study 2. Women undergoing urgency or emergency cesarean deliveries 3. Women with a history of previous cesarean section or abdominal surgery 4. Women with multifetal pregnancies 5. Necessity of general anesthesia 6. Use of anticoagulants 7. Patients needing a median longitudinal abdominal section 8. Patients with pacemakers 9. Allergy to cephalosporins 10. Any medical disorder that can affect wound healing as diabetes, hypertension, hepatic or renal diseases, chronic anemia, chronic skin conditions, congenital or acquired bleeding diathesis. |
Country | Name | City | State |
---|---|---|---|
Italy | Azienda Ospedaliero-Universitaria "Consorziale Policlinico" | Bari |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incision blood loss | This will be calculated by weighing the gauze pre and postoperatively (1mg = 1ml) after complete hemostasis will be achieved. | During surgery | |
Secondary | Incision time | We will compare incisional time by using a digital clock. The incisional time will be established as follows: when skin incision will be made, the surgeon will verbally announce "start ". Once the parietal peritoneum will be opened, the surgeon will announce "stop". The incision time will be calculated as the difference between "start" and "stop" times. | During surgery | |
Secondary | Total surgery time | Total surgery time will be the time between the start of the skin incision and the completion of the skin suture. | During surgery | |
Secondary | Post-operative pain assessed by VAS | Post-operative pain will be evaluated for each participant at 1, 4, 8, 16, 24, 48, 72 hours postoperatively, by using the Visual Analog Scale (VAS). The VAS consists of a 10 cm long horizontal line with its extremes marked as 'no pain' (0) and 'worst pain imaginable' (10). | During the first three days after surgery | |
Secondary | Wound complications | Will include edema, seroma, hematoma, dehiscence, and infection. The wound will be evaluated 24h and 72h after surgery, before patients discharge. Then, outpatient wound evaluation will be made 7 and 30 days after surgery. | During the first month after surgery | |
Secondary | Cosmetic wound evaluation assessed by POSAS | The cosmetic aspect of the wound will be evaluated outpatient 30 days after surgery by using the Patient and Observer Scar Assessment Scale (POSAS), that is a questionnaire that was developed to assess scar quality. It consists of two separate six-item scales (Observer Scale and Patient Scale), both of which are scored on a 10-point rating scale (1 = best result; 10 = worst result). | One month after surgery |
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