Post-Cesarean Gastrointestinal Dysfunction

NCT07067021 | Completed

• 1 other identifier: FSCH-SB-2024/06-15
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

General anesthesia has a range of effects that can lead to gastrointestinal (GI) system dysfunctions in the postoperative period. These effects are linked to various factors, from the pharmacological properties of anesthetic agents to neurohumoral effects triggered by surgical stress. Commonly encountered GI dysfunctions include nausea and vomiting, abdominal distension due to decreased intestinal peristalsis and the postoperative inflammatory response, delayed gastric emptying, ileus, fatigue, and delayed initiation of oral feeding. These conditions can prolong hospital stay, increase treatment costs, and reduce patient comfort. In clinical practice, protecting GI function and preventing complications after general anesthesia are of great importance. One of the main goals of applying Enhanced Recovery After Surgery (ERAS) protocols is to reduce the surgical stress response, thereby promoting rapid recovery and improving GI functions. Postoperative gastrointestinal (GI) dysfunction after cesarean section is a common complication that negatively impacts the recovery process. This condition manifests with symptoms such as abdominal pain, nausea, vomiting, and an inability to pass flatus, and it can prolong hospital stay and increase costs. Opioid analgesics are known to negatively affect postoperative GI motility, and regional anesthesia techniques can alleviate these problems by reducing opioid requirements. Fascial plane blocks like the TAP block are thought to reduce somatic and visceral pain by injecting local anesthetics between the deep and superficial layers of the fascia, and may positively influence GI functions through sympathetic blockade. This study aims to observationally investigate the effect of ultrasound-guided transabdominal plane (TAP) block on postoperative gastrointestinal system (GI) dysfunctions in patients who have undergone cesarean section.

Conditions

Cesarean Section Surgery; TAP Blocks; Gastrointestinal Dysfunction

Keywords

Cesarean Section; TAP Block; Gastrointestinal Dysfunction

Outcome Measures

Primary Outcomes (1)

• PRO-diGI (Patient-Reported Outcome Measure for Gastrointestinal Dysfunction after major abdominal surgery)

  Patients will be asked 15 questions from the PRO-diGI (Patient-Reported Outcome Measure for Gastrointestinal Dysfunction after major abdominal surgery) scale to assess GI dysfunction.The first response option was given the highest score of 4 points, and the last response option was given the lowest score of 0 points. Patients received a maximum score of 60 points when their GI function was in the best condition.

  24. hour, 48. hour, 72. hour

Secondary Outcomes (1)

• The Obstetric Quality-of-Recovery score (ObsQoR-11)

  24. hour

Study Arms (2)

Group T: Patients who received a TAP block under general anesthesia.

Group T: This group consists of patients who underwent Cesarean section under general anesthesia and received a Transabdominal Plane (TAP) block during the surgery. The TAP block is a regional anesthetic technique administered for postoperative pain management.

Group C: Patients who did not receive a TAP block.

Group C (Control Group) Description: This group consists of patients who underwent Cesarean section under general anesthesia but did not receive a TAP block during the surgery. This group will receive standard postoperative pain management for comparison with the effects of the TAP block.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Turkish kohort

You may qualify if:

• Patients undergoing elective cesarean section surgery under general anesthesia
• Patients with American Society of Anesthesiologists (ASA) physical status I-II-III
• Patients able to understand and respond to the Visual Analog Scale (VAS) for pain
• No history of drug or alcohol addiction
• No coagulation disorders
• No anatomical abnormalities of the gastrointestinal system
• No gastrointestinal motility disorders
• No previous abdominal surgery
• No allergies to local anesthetic drugs
• No history of diabetes mellitus
• No severe systemic diseases
• No intraoperative surgical complications (such as bleeding, conversion to open surgery, or organ injury)
• Successful block achievement (for relevant groups)

You may not qualify if:

• Patients undergoing emergency cesarean section under general anesthesia
• Patients with American Society of Anesthesiologists (ASA) physical status IV-V
• Patients unable to understand the Visual Analog Scale (VAS) for pain (due to cognitive or psychiatric disorders, or mental impairments)
• Emergency operations
• Patients with drug or alcohol addiction
• Coagulation disorders
• Anatomical abnormalities of the gastrointestinal system
• Gastrointestinal motility disorders
• Previous abdominal surgery
• Allergy to local anesthetic drugs
• Diabetes mellitus
• Presence of severe systemic disease
• Intraoperative surgical complications (such as bleeding, conversion to open surgery, organ injury, etc.)
• Unsuccessful block placement

Sponsors & Collaborators

• Elazıg Fethi Sekin Sehir Hastanesi: lead

Study Sites (1)

Elazığ Fethi Sekin City Hospital

Elâzığ, Elâzığ, 23100, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: July 15, 2025
• Study Start: June 15, 2025
• Primary Completion: June 30, 2025
• Study Completion: July 2, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-06

Locations

TU (1)