Cesarean Section, Postoperative Pain
Conditions
Keywords
Cesarean Section, Postoperative Pain,, Fascial Closure Surgical Technique, Early Mobilization, Obstetric Surgery, Pain Management
Brief summary
This randomized controlled trial evaluates whether a guide-suture-assisted modified fascial closure technique reduces postoperative pain and improves early functional recovery compared with classical continuous fascial closure in women undergoing elective cesarean section. Cesarean section is a common surgical procedure, and postoperative pain may delay mobilization and recovery. Fascial closure technique may influence postoperative pain by affecting tissue tension and alignment. The guide-suture-assisted modified closure technique is designed to improve fascial alignment and reduce mechanical tension during closure. Participants undergoing elective cesarean section with Pfannenstiel incision are randomly assigned in a 1:1 ratio to either classical continuous fascial closure or guide-suture-assisted modified continuous fascial closure. Postoperative pain intensity is assessed using validated pain scales, and functional recovery is evaluated by measuring walking distance during the early postoperative period. The study aims to determine whether this modified surgical technique improves postoperative comfort and facilitates earlier mobilization compared with the conventional technique.
Detailed description
This prospective, single-center, randomized, parallel-group clinical trial evaluates the effect of a guide-suture-assisted modified continuous fascial closure technique on postoperative pain and functional recovery following elective cesarean section. Eligible participants include women aged 18 to 35 years undergoing elective cesarean section with Pfannenstiel incision. Participants are randomly assigned in a 1:1 ratio to either classical continuous fascial closure or guide-suture-assisted modified continuous fascial closure using a sealed-envelope randomization method. All procedures are performed by the same experienced surgeon under spinal anesthesia using standardized surgical techniques. In the classical closure group, fascial closure is performed using continuous suturing with Vicryl 1-0 (polyglactin 910). In the modified closure group, a guide suture is first placed at the intended terminal corner of the fascial incision to improve alignment and reduce tissue tension, followed by continuous fascial closure using the same suture material. Postoperative pain is assessed using the Visual Analog Scale (VAS), Numeric Rating Scale (NRS), and Short-Form McGill Pain Questionnaire (SF-MPQ) at 6, 12, 24, and 48 hours after surgery. Functional recovery is evaluated by measuring walking distance at the same time points. Postoperative analgesic use within 48 hours is also recorded. The primary objective is to evaluate whether the modified fascial closure technique reduces early postoperative pain compared with classical continuous closure. Secondary objectives include assessment of functional recovery and analgesic requirements. This study provides evidence regarding a simple surgical modification that may improve postoperative recovery following cesarean section.
Interventions
PROCEDUREClassical continuous fascial closure
Fascial closure was performed using a conventional continuous suturing technique with Vicryl 1-0 (polyglactin 910). The suture was started at one corner of the fascial incision and continued to the opposite end without the use of a guide suture. All other surgical procedures were standardized.
PROCEDUREGuide-suture-assisted modified fascial closure
A guide suture using Vicryl 1-0 (polyglactin 910) was placed at the terminal corner of the fascial incision prior to continuous closure. This guide suture was used to improve fascial alignment and reduce tissue tension. Continuous fascial closure was then performed using Vicryl 1-0. All other surgical procedures were standardized.
Sponsors
Necmettin Erbakan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This study was conducted as an open-label trial. Due to the nature of the surgical interventions, masking of participants, care providers, and investigators was not feasible.
Intervention model description
Participants were randomly assigned in a 1:1 ratio to either classical continuous fascial closure or guide-suture-assisted modified continuous fascial closure. Each participant received only one intervention, and outcomes were compared between parallel groups.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
Women aged 18 to 35 years Scheduled for elective cesarean section Singleton pregnancy Gestational age ≥ 37 weeks American Society of Anesthesiologists (ASA) physical status class I or II Planned cesarean section with Pfannenstiel incision Ability to provide written informed consent
Exclusion criteria
Emergency cesarean section History of previous cesarean section Severe intra-abdominal adhesions Known coagulopathy or bleeding disorders Active infection Intraoperative complications Inability or unwillingness to provide informed consent \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain intensity measured by Visual Analog Scale (VAS) | 6, 12, 24, and 48 hours after cesarean section | Postoperative pain intensity is assessed using a 0-10 Visual Analog Scale (VAS), where higher scores indicate greater pain severity. Pain scores are recorded at 6, 12, 24, and 48 hours following surgery and compared between the classical continuous fascial closure group and the guide-suture-assisted modified fascial closure group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity during movement measured by Numeric Rating Scale (NRS) | 6, 12, 24, and 48 hours after cesarean section | Pain during movement is assessed using a 0-10 Numeric Rating Scale (NRS), where higher scores indicate greater pain intensity. Scores are recorded at each postoperative time point. |
| Pain quality measured by Short-Form McGill Pain Questionnaire (SF-MPQ) | 6, 12, 24, and 48 hours after cesarean section | Pain quality and intensity are evaluated using the Short-Form McGill Pain Questionnaire (SF-MPQ), which assesses sensory and affective components of pain. |
| Functional recovery measured by walking distance | 6, 12, 24, and 48 hours after cesarean section | Functional recovery is assessed by measuring walking distance in meters at each postoperative time point. Greater walking distance indicates better functional recovery. |
| Postoperative analgesic consumption | Within 48 hours after cesarean section | The type and frequency of analgesic medications administered during the first 48 hours after surgery are recorded and compared between study groups. |
Countries
Turkey (Türkiye)
Outcome results
None listed