Analgesic Effects of Intrathecal Morphine and Transversalis Plane Block After Cesarean Delivery

April 5, 2026 updated by: Vezirköprü State Hospital

The Effects of Intrathecal Morphine and Ultrasound-Guided Bilateral Transversalis Fascia Plane Block on Postoperative Acute Pain and Patient Satisfaction in Patients Undergoing Elective Cesarean Section

A comparison of postoperative pain levels, patient satisfaction, and side effects is planned between patients who received morphine during spinal anesthesia for cesarean section and patients who did not receive morphine but underwent bilateral transverse fascial plane block.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

It is known that cesarean deliveries are increasingly performed worldwide today. Cesarean operations can cause severe postoperative pain; inadequate control of this pain can lead to negative outcomes such as increased opioid requirements, delayed recovery, chronic pain syndrome, and postpartum depression . Furthermore, inadequate pain control may limit the mother's ability to care for her newborn, negatively affecting mother-newborn interaction, reducing breastfeeding success, and weakening the mother-baby bond.

The ideal analgesic approach should include agents that do not affect the mother's functions and have minimal transfer into breast milk. In this regard, current guidelines recommend multimodal analgesia protocols that include the use of neuraxial local anesthetics and opioids, nonsteroidal anti-inflammatory drugs (NSAIDs), and paracetamol . Although morphine administered via the neuraxial route can provide effective analgesia for the first 12-24 hours postoperatively, its use may be limited due to undesirable side effects such as delayed respiratory depression, nausea, vomiting, and pruritus . For these reasons, alternative methods aimed at reducing opioid use have come to the fore in recent years. Fascial plane blocks performed under ultrasound guidance are recommended as a complementary part of multimodal analgesia in situations where neuroaxial opioids are not used or where analgesia control is inadequate. First described by Hebbard in 2009, the Transverse Fascial Plane Block (TFPB) provides analgesia by targeting the proximal branches of the T12 and L1 nerves between the transversus abdominis muscle and the transverse fascia. TFPB is used to relieve postoperative pain, particularly after lower abdominal surgeries, cesarean sections, and appendectomies.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
117

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Samsun, Turkey (Türkiye)
        • Vezirköprü State Hospital
    • Vezirköprü
      • Samsun, Vezirköprü, Turkey (Türkiye)
        • Vezirköprü State Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patient who underwent cesarean section under spinal anesthesia

Description

Inclusion Criteria:

  • Woman aged 18-45
  • ASA physical status II
  • Patients undergoing cesarean section under spinal anesthesia
  • Patients received intrathecal morphine and bilateral TFB block.

Exclusion Criteria:

  • Contraindications to spinal anesthesia
  • ASA physical statu III- IV
  • History of hypersensitivity or allergy to the study drugs
  • Pregnancy-related diseases ( preeclampsia, eclampsia, gestational diabetes, gestational hypertension, placental abnormalities vb)
  • Obesity (body mass index > 35 kg/m2)
  • Cognitive impairment or inability to cooperate
  • Alcohol or drug dependence
  • Patients who do not provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
intrathecal morphine, transversalis fascia plane block

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain intensity assessed by Numeric Rating Scale (NRS)
Time Frame: 2nd, 6th, 12th, and 24th hours postoperatively
Pain intensity, will be assessed using the Numeric Rating Scale ("0" no pain, "10" most severe pain experienced) at rest and during movement (passive flexion of the legs).
2nd, 6th, 12th, and 24th hours postoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
1. Time to first opioid request
Time Frame: First 24 hours postoperatively
Time from the end of surgery to the first postoperative opioid request, recorded in hours
First 24 hours postoperatively
2. Sedation Level
Time Frame: 2, 6, 12 and 24 hours postoperatively
Postoperative sedation level will be assessed at 2nd, 6th, 12th and 24 hours using Ramsay Sedation Scale (RSS) (1 = anxious or agitated, 2 = cooperative and oriented, 3 = responds to commands only, 4 = brisk responde to stimulus, 5 = sluggish response, 6 = no response)
2, 6, 12 and 24 hours postoperatively
Incidence postoperative nausea and vomiting
Time Frame: First 24 hours postoperatively

The presence of nausea and/or vomiting will be recorded during the first 24 postoperative hours PONV SCORE 0: No nausea or vomiting

  1. Nause without vomiting
  2. One episode of vomiting
  3. More than one episode of vomiting
First 24 hours postoperatively
Incidence of pruritis
Time Frame: First 24 hours postoperatively

The incidence of pruritis will be recorded during the first 24 postoperative hours.

Pruritus will be assessed using the following scale:

0: No pruritis

  1. Mild pruritis (sensation without need to scratch)
  2. Moderate pruritis ( requires scratching)
  3. Severe pruritis (requires treatment)
First 24 hours postoperatively
Obstetric Quality of Recovery -11(ObsQoR-11) Score
Time Frame: 24 hours postoperatively
Quality of recovery will be assessed using the Obstetric Quality of Recovery -11(ObsQoR-11) Score questionnaire, which concists of 11 items scored from 0 to 10, with a total score ranging from 0-110, where higher scores indicate better postoperative recovery.
24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vezirköprü State Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: BETÜL YILMAZ, Specialist medical doctor, Vezirköprü State Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OMU KAEK 2025/245

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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