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Caesarean SectionNCT07490795

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

An observational study of Caesarean Section and Postoperative Analgesia, run by Vezirköprü State Hospital at 2 sites 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

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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Caesarean Section, Postoperative Analgesia
How many people
117 participants
Where
2 sitesTurkey (Türkiye)
Study dates
15 Nov 2025to 15 Mar 2026
How long will I take part?
5 Months
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: Patient who underwent cesarean section under spinal anesthesia

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites

  • Vezirköprü State Hospital

    Samsun, Vezirköprü

  • Vezirköprü State Hospital

    Samsun

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Keywords
Transversalis Fascia Plane Block, Intrathecal Morphine, Caesarean Section, Postoperative Analgesia

What participants receive

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

Study groups in NCT07490795
Study groupRoleWhat they receive
intrathecal morphine, transversalis fascia plane blockNot described

What is being measured

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

  1. Pain intensity assessed by Numeric Rating Scale (NRS)

    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).

    Measured: 2nd, 6th, 12th, and 24th hours postoperatively

Secondary outcomes (5)

  1. 1. Time to first opioid request

    Time from the end of surgery to the first postoperative opioid request, recorded in hours

    Measured: First 24 hours postoperatively

  2. 2. Sedation Level

    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)

    Measured: 2, 6, 12 and 24 hours postoperatively

  3. Incidence postoperative nausea and vomiting

    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

    Measured: First 24 hours postoperatively

  4. Incidence of pruritis

    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)

    Measured: First 24 hours postoperatively

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

    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.

    Measured: 24 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 posted24 Mar 2026
  2. Study start15 Nov 2025
  3. Primary completion15 Nov 2025
  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
Other
Time perspective
Prospective
Enrolment
117 participants (actual)
Target duration
5 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07490795
Sponsor's protocol ID
OMU KAEK 2025/245
Status last verified
Apr 2026
First submitted
10 Mar 2026
Last updated
7 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Nair A, Dudhedia U, Rangaiah M, Borkar N. Ultrasound-guided transversalis fascia plane block for postoperative analgesia: A systematic review and meta-analysis. Indian J Anaesth. 2023 Apr;67(4):331-342. doi: 10.4103/ija.ija_43_23. Epub 2023 Apr 10.

    PubMed 37303881

  • Pangthipampai P, Dejarkom S, Poolsuppasit S, Luansritisakul C, Tangchittam S. Bilateral posterior Quadratus Lumborum block for pain relief after cesarean delivery: a randomized controlled trial. BMC Anesthesiol. 2021 Mar 25;21(1):90. doi: 10.1186/s12871-021-01309-6.

    PubMed 33761894

  • Kosem, A., Ozcan, M. S., Iscan, G., Ozden, E. S., Alkaya Solmaz, F., & Kirdemir, P. (2024). Transversalis Fascia Plane Block Compared with Transversus Abdominis Plane Block for Postoperative Analgesia in Cesarean Section Under Spinal Anesthesia: A Retrospective Study. JARSS, 32(1), 11-19.

  • Salama ER. Ultrasound-guided bilateral quadratus lumborum block vs. intrathecal morphine for postoperative analgesia after cesarean section: a randomized controlled trial. Korean J Anesthesiol. 2020 Apr;73(2):121-128. doi: 10.4097/kja.d.18.00269. Epub 2019 Mar 8.

    PubMed 30852882

  • Lim G, Facco FL, Nathan N, Waters JH, Wong CA, Eltzschig HK. A Review of the Impact of Obstetric Anesthesia on Maternal and Neonatal Outcomes. Anesthesiology. 2018 Jul;129(1):192-215. doi: 10.1097/ALN.0000000000002182.

    PubMed 29561267

  • Carvalho B, Butwick AJ. Postcesarean delivery analgesia. Best Pract Res Clin Anaesthesiol. 2017 Mar;31(1):69-79. doi: 10.1016/j.bpa.2017.01.003. Epub 2017 Jan 12.

    PubMed 28625307

  • 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

Questions about this trial

What is this clinical trial studying?

An observational study of Caesarean Section and Postoperative Analgesia, run by Vezirköprü State Hospital at 2 sites 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 4 inclusion and 8 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 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Pain intensity assessed by Numeric Rating Scale (NRS) (time frame: 2nd, 6th, 12th, and 24th 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 NCT07490795, which also lists 7 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 7 Apr 2026.

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