Cesarean Section SurgeryNCT07067021
Post-Cesarean Gastrointestinal Dysfunction
An observational study of Cesarean Section Surgery and TAP Blocks, run by Elazıg Fethi Sekin Sehir Hastanesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Cesarean Section Surgery, TAP Blocks, Gastrointestinal Dysfunction
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2025to 2 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Turkish kohort
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Elazığ Fethi Sekin City Hospital
Elâzığ, Elâzığ, 23100
About this study
Official title: Detection of Postoperative Gastrointestinal System Dysfunctions in Patients Undergoing Cesarean Section With Transabdominal Block Under General Anesthesia"
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.
Read more
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.
Read the detailed description
Postoperative Gastrointestinal Dysfunction (POGD) refers to a collection of clinical symptoms that arise after general anesthesia, encompassing disruptions in normal gastrointestinal (GI) peristaltic activity and imbalances in absorption and secretion. This condition develops as a result of a complex interaction of neurological, inflammatory, pharmacological, and metabolic factors. These symptoms include nausea and vomiting, gastroparesis, delayed flatus and defecation, delayed oral feeding, abdominal distension, and pathophysiological changes like paralytic ileus.
Many risk factors affect POGD after Cesarean Delivery (CD) surgery. Predisposing factors include the surgical method, degree of abdominal adhesions, amount of opioid use, postoperative blood transfusion, bowel manipulation, duration of surgery, advanced age, and infection and inflammation statuses.
In patients undergoing CD under general anesthesia, POGD disorders are observed due to surgical stress and opioid use. The Enhanced Recovery After Cesarean Delivery (ERAC) protocol offers a multidisciplinary, holistic approach that reduces POGD and accelerates maternal recovery through a set of perioperative care guidelines.
The Transabdominal Plane (TAP) block, a regional anesthesia technique with proven efficacy in postoperative pain management after CD, holds an important place within the modern multimodal analgesia approach of ERAC protocols. By reducing opioid consumption, it decreases the prevalence of POGD and enhances maternal comfort, indirectly contributing to newborn care.
To reflect patients' subjective experiences regarding postoperative GI symptoms, the PRO-diGI (Patient-Reported Outcome Measure for Gastrointestinal Dysfunction after major abdominal surgery) scale has been developed and is being effectively used. The Obstetric Quality-of-Recovery score (ObsQoR-11) is a Patient-Reported Outcome Measure (PROM) developed to comprehensively and standardly assess the quality of maternal recovery after childbirth. This score, whose reliability and validity have been proven in the Turkish population (ObsQoR-11T), clinically and objectively evaluates the postpartum period by considering both physical symptoms and the mother's psychological well-being and functional capacity.
This study aims to determine the effects of ultrasound-guided TAP block on recovery quality assessment (ObsQoR-11T score), postoperative gastrointestinal dysfunction (PRO-diGI score), and gastrointestinal motility (Perlas Score determined by USG) in patients who have undergone CD.
- Keywords
- Cesarean Section, TAP Block, Gastrointestinal Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24. hour, 48. hour, 72. hour
Secondary outcomes (1)
The Obstetric Quality-of-Recovery score (ObsQoR-11)
The Obstetric Quality-of-Recovery score (ObsQoR-11) is a Patient-Reported Outcome Measure (PROM) developed to provide a standardized and comprehensive assessment of maternal postpartum recovery quality.The ObsQoR-11 score is a scale used to assess the quality of recovery in mothers after a cesarean section, ranging from 0 (indicating the worst recovery) to 110 (indicating the best recovery); higher scores signify a better quality of recovery in terms of the mother's physical symptoms, psychological well-being, and functional capacity.
Measured: 24. hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start15 Jun 2025
- Primary completion30 Jun 2025
- Study completion2 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elazıg Fethi Sekin Sehir Hastanesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07067021
- Sponsor's protocol ID
- FSCH-SB-2024/06-15
- Status last verified
- Jun 2025
- First submitted
- 4 Jul 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Postoperative Gastrointestinal System Dysfunctions in Patients Undergoing Cesarean Section With Transabdominal Block Under General Anesthesia"
- ClinicalTrials.gov ID
- NCT07067021
- Acronym / sponsor ID
- FSCH-SB-2024/06-15
- Keywords
- Cesarean Section, TAP Block, Gastrointestinal Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Elazıg Fethi Sekin Sehir HastanesiUniversity, hospital or other
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 2 Jul 2025 (actual)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Postoperative Gastrointestinal Dysfunction (POGD) refers to a collection of clinical symptoms that arise after general anesthesia, encompassing disruptions in normal gastrointestinal (GI) peristaltic activity and imbalances in absorption and secretion. This condition develops as a result of a complex interaction of neurological, inflammatory, pharmacological, and metabolic factors. These symptoms include nausea and vomiting, gastroparesis, delayed flatus and defecation, delayed oral feeding, abdominal distension, and pathophysiological changes like paralytic ileus.
Many risk factors affect POGD after Cesarean Delivery (CD) surgery. Predisposing factors include the surgical method, degree of abdominal adhesions, amount of opioid use, postoperative blood transfusion, bowel manipulation, duration of surgery, advanced age, and infection and inflammation statuses.
In patients undergoing CD under general anesthesia, POGD disorders are observed due to surgical stress and opioid use. The Enhanced Recovery After Cesarean Delivery (ERAC) protocol offers a multidisciplinary, holistic approach that reduces POGD and accelerates maternal recovery through a set of perioperative care guidelines.
The Transabdominal Plane (TAP) block, a regional anesthesia technique with proven efficacy in postoperative pain management after CD, holds an important place within the modern multimodal analgesia approach of ERAC protocols. By reducing opioid consumption, it decreases the prevalence of POGD and enhances maternal comfort, indirectly contributing to newborn care.
To reflect patients' subjective experiences regarding postoperative GI symptoms, the PRO-diGI (Patient-Reported Outcome Measure for Gastrointestinal Dysfunction after major abdominal surgery) scale has been developed and is being effectively used. The Obstetric Quality-of-Recovery score (ObsQoR-11) is a Patient-Reported Outcome Measure (PROM) developed to comprehensively and standardly assess the quality of maternal recovery after childbirth. This score, whose reliability and validity have been proven in the Turkish population (ObsQoR-11T), clinically and objectively evaluates the postpartum period by considering both physical symptoms and the mother's psychological well-being and functional capacity.
This study aims to determine the effects of ultrasound-guided TAP block on recovery quality assessment (ObsQoR-11T score), postoperative gastrointestinal dysfunction (PRO-diGI score), and gastrointestinal motility (Perlas Score determined by USG) in patients who have undergone CD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Turkish kohort
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PRO-diGI (Patient-Reported Outcome Measure for Gastrointestinal Dysfunction after major abdominal surgery)
Time frame: 24. hour, 48. hour, 72. hour
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.
1 secondary outcome
The Obstetric Quality-of-Recovery score (ObsQoR-11)
Time frame: 24. hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section Surgery and TAP Blocks, run by Elazıg Fethi Sekin Sehir Hastanesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PRO-diGI (Patient-Reported Outcome Measure for Gastrointestinal Dysfunction after major abdominal surgery) (time frame: 24. hour, 48. hour, 72. hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.