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Cesarean DeliveryNCT07374133

Intrathecal Morphine vs Transversalis Fascia Plane Block After Cesarean Delivery

An observational study of Cesarean Delivery and Postoperative Analgesia, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This prospective single-center study compares intrathecal morphine and ultrasound-guided bilateral transversalis fascia plane block for postoperative analgesia in patients undergoing elective cesarean delivery under spinal anesthesia. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Feb 2026to 15 Mar 2026
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 45 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: The study population consists of parturients aged 18-45 years undergoing elective cesarean delivery under spinal anesthesia at a single tertiary care center. Participants are followed prospectively as a single observational cohort, and postoperative outcomes are compared between exposure groups defined by the routine clinical analgesic approach, including intrathecal morphine or ultrasound-guided bilateral transversalis fascia plane block.

Who may be able to join

  • Female parturients aged 18 to 45 years
  • Gestational age greater than 37 weeks
  • American Society of Anesthesiologists (ASA) physical status II
  • Scheduled for elective cesarean delivery under spinal anesthesia
  • Willingness to participate in the study

Who cannot join

  • Refusal to participate in the study
  • Cesarean delivery performed under general anesthesia
  • Conversion to general anesthesia after spinal anesthesia
  • ASA physical status greater than III
  • Multiple pregnancy
  • Contraindications to central or peripheral regional anesthesia techniques
Show all 9Show fewer
  • Body mass index (BMI) greater than 35 kg/m²
  • Known allergy or hypersensitivity to local anesthetics or opioids
  • Presence of significant organ dysfunction (e.g., severe hepatic or renal disease)

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Giresun University Faculty of Medicine

    Giresun

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Intrathecal Morphine and Ultrasound-Guided Bilateral Transversalis Fascia Plane Block for Post-Cesarean Analgesia

This prospective single-center study compares intrathecal morphine and ultrasound-guided bilateral transversalis fascia plane block for postoperative analgesia in patients undergoing elective cesarean delivery under spinal anesthesia. The primary outcome is the number of parturients requiring rescue analgesia within the first 24 hours postoperatively. The secondary outcomes include postoperative pain scores, rescue analgesia requirement, nausea/vomiting, pruritus, and obstetric quality of recovery (ObsQoR-11).

Read the detailed description

This prospective single-center study investigates postoperative acute pain management in parturients aged 18-45 years undergoing elective cesarean delivery under spinal anesthesia.Participants will be followed as a single prospective cohort, and postoperative outcomes will be compared between exposure groups defined by the routine clinical analgesic approach (intrathecal morphine or ultrasound-guided bilateral transversalis fascia plane block).A total of 60 patients are planned to be enrolled. Eligible participants are term parturients with a gestational age greater than 37 weeks, classified as American Society of Anesthesiologists (ASA) physical status II, and scheduled for elective cesarean delivery under spinal anesthesia. Patients will be excluded if they refuse participation, undergo cesarean delivery under general anesthesia, have ASA physical status greater than III, multiple pregnancy, conversion to general anesthesia after spinal anesthesia, contraindications to central or peripheral regional anesthesia techniques, body mass index greater than 35 kg/m², known allergy or hypersensitivity to local anesthetics or opioids, or significant organ dysfunction such as severe hepatic or renal disease.

In routine clinical practice, the postoperative analgesic approach is determined through shared decision-making based on patient preference and the responsible anesthesiologist's clinical assessment. Accordingly, two postoperative analgesic strategies will be compared: addition of intrathecal morphine to spinal anesthesia and ultrasound-guided bilateral transversalis fascia plane block.

Following standard ASA monitoring, spinal anesthesia is performed in the sitting position at the L4-5 interspace using a 26-gauge spinal needle. After confirmation of free cerebrospinal fluid flow, 12.5 mg of 0.5% hyperbaric bupivacaine combined with 20 micrograms of fentanyl is administered intrathecally. In the intrathecal morphine group, 100 micrograms of morphine is added to the intrathecal anesthetic solution. Sensory block level is assessed using the pinprick test, and surgery is initiated when a T6 sensory level is achieved.

In the transversalis fascia plane block group, the block is performed in the postoperative period with the patient in the supine position. An ultrasound probe is placed transversely just cranial to the iliac crest, and the abdominal wall layers, transversalis fascia, retroperitoneal fat, and peritoneum are identified. Using an in-plane needle approach, after hydrodissection with 3 mL of normal saline, 20 mL of 0.25% bupivacaine is injected into the plane deep to the transversalis fascia. The procedure is repeated on the contralateral side.

For postoperative nausea and vomiting prophylaxis, 4 mg of intravenous ondansetron is administered near skin closure, and uterotonic agents are given according to institutional protocols. Postoperative analgesia consists of 1 g intravenous paracetamol every 8 hours and intramuscular diclofenac every 12 hours. When the Numeric Rating Scale (NRS) score exceeds 4, rescue analgesia is provided with 100 mg intravenous tramadol administered as a 30-minute infusion, with a maximum daily dose of 300 mg.

The primary outcome of the study is the number of participants requiring rescue analgesia within the first 24 hours postoperatively. Secondary outcomes include postoperative pain intensity assessed using the NRS at rest and during activity at 0, 3, 6, 12, and 24 hours; incidence and severity of postoperative nausea and vomiting assessed using a 0-4 verbal rating scale; incidence and severity of pruritus assessed using a 0-3 scale at the same time points; and patient satisfaction and quality of recovery assessed using the Obstetric Quality of Recovery-11(ObsQoR-11) questionnaire at 24 and 48 hours after surgery.

All data will be collected by an anesthesia resident not involved in the procedures, anonymized, and handled in accordance with the Declaration of Helsinki. The study will be reported in compliance with the STROBE reporting guidelines, and participant confidentiality will be strictly maintained.

Keywords
Cesarean Sections, Postoperative Pain, Analgesia, Ultrasonography, Interventional, Spinal Anesthesia
Medical subject headings
Pain, Postoperative, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07374133
Study groupRoleWhat they receive
Elective Cesarean Delivery CohortThis cohort includes parturients aged 18-45 years undergoing elective cesarean delivery under spinal anesthesia. Participants are followed prospectively as a single cohort. Postoperative outcomes are compared between exposure groups defined by the routine clinical analgesic approach, including intrathecal morphine or ultrasound-guided bilateral transversalis fascia plane block.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Requirement for Rescue Analgesia Within 24 Hours

    The primary outcome is the number of participants who require rescue analgesia within the first 24 hours after cesarean delivery. Rescue analgesia is administered when the Numeric Rating Scale (NRS) pain score exceeds 4 and consists of intravenous tramadol given according to the institutional protocol.

    Measured: Within the first 24 hours postoperatively

Secondary outcomes (5)
  1. Postoperative Pain Intensity (NRS) at Rest

    Pain intensity at rest assessed using the Numeric Rating Scale (NRS, 0-10; higher scores indicate worse pain) at predefined postoperative time points.

    Measured: 0, 3, 6, 12, and 24 hours postoperatively

  2. Postoperative Pain Intensity (NRS) During Activity

    Pain intensity during activity assessed using the Numeric Rating Scale (NRS, 0-10; higher scores indicate worse pain) at predefined postoperative time points.

    Measured: 0, 3, 6, 12, and 24 hours postoperatively

  3. Postoperative Nausea and Vomiting (PONV) Severity Score

    Severity of postoperative nausea and vomiting assessed using a 0-4 verbal rating scale at predefined postoperative time points.

    Measured: 0, 3, 6, 12, and 24 hours postoperatively

  4. Pruritus Severity Score

    Severity of pruritus assessed using a 0-3 scale at predefined postoperative time points.

    Measured: 0, 3, 6, 12, and 24 hours postoperatively

  5. Obstetric Quality of Recovery (ObsQoR-11T) Total Score

    Quality of recovery assessed using the Obstetric Quality of Recovery-11T (ObsQoR-11T) questionnaire. Total score range is 0-110, with higher scores indicating better recovery.

    Measured: 24 and 48 hours postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2026
  2. Study start1 Feb 2026
  3. Primary completion15 Mar 2026
  4. Study completion15 Mar 2026

Resources

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
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07374133
Sponsor's protocol ID
CS-TFPB
Status last verified
May 2026
First submitted
20 Jan 2026
Last updated
13 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Serifsoy TE, Tulgar S, Selvi O, Senturk O, Ilter E, Peker BH, Ozer Z. Evaluation of ultrasound-guided transversalis fascia plane block for postoperative analgesia in cesarean section: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2020 Feb;59:56-60. doi: 10.1016/j.jclinane.2019.06.025. Epub 2019 Jun 27.

    PubMed 31255890
  • Jemal B, Mohammed F, Tesema HG, Ahmed S, Mohammed A, Regasa T, Obsa MS. Analgesic Efficacy of Spinal Morphine in Comparison With Transversus Abdominis Plane Block for Postoperative Pain Management in Patients Undergoing Cesarean Section Under Spinal Anesthesia: A Randomized Controlled Trial. Front Med (Lausanne). 2022 Feb 9;9:814538. doi: 10.3389/fmed.2022.814538. eCollection 2022.

    PubMed 35223910
  • Bilgin S, Aygun H, Genc C, Dost B, Tulgar S, Kaya C, Sertoz N, Koksal E. Comparison of ultrasound-guided transversalis fascia plane block and anterior quadratus lumborum block in patients undergoing caesarean delivery: a randomized study. BMC Anesthesiol. 2023 Jul 21;23(1):246. doi: 10.1186/s12871-023-02206-w.

    PubMed 37480008

Questions about this trial

What is this clinical trial studying?

An observational study of Cesarean Delivery and Postoperative Analgesia, run by Ondokuz Mayıs University 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 5 inclusion and 9 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 13 May 2026. 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?

Requirement for Rescue Analgesia Within 24 Hours (time frame: Within the first 24 hours postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07374133, which also lists 3 linked publications.

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 13 May 2026.

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