NCT07490795

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2025

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2026

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 24, 2026

Completed
Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

Same day

First QC Date

March 10, 2026

Last Update Submit

March 21, 2026

Conditions

Caesarean SectionPostoperative Analgesia

Keywords

Transversalis Fascia Plane BlockIntrathecal MorphineCaesarean SectionPostoperative Analgesia

Outcome Measures

Primary Outcomes (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).

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

Secondary Outcomes (5)

  • 1. Time to first opioid request

    First 24 hours postoperatively

  • 2. Sedation Level

    2, 6, 12 and 24 hours postoperatively

  • Incidence postoperative nausea and vomiting

    First 24 hours postoperatively

  • Incidence of pruritis

    First 24 hours postoperatively

  • Obstetric Quality of Recovery -11(ObsQoR-11) Score

    24 hours postoperatively

Study Arms (1)

intrathecal morphine, transversalis fascia plane block

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patient who underwent cesarean section under spinal anesthesia

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Vezirköprü State Hospital

Samsun, Vezirköprü, Turkey (Türkiye)

Location

Vezirköprü State Hospital

Samsun, Turkey (Türkiye)

Location

Related Publications (7)

  • 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.

    PMID: 37303881BACKGROUND

  • Pangthipampai, P., Dejarkom, S., Poolsuppasit, S. et al. Bilateral posterior Quadratus Lumborum block for pain relief after cesarean delivery: a randomized controlled trial. BMC Anesthesiol 21

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 30852882BACKGROUND

  • Lim G, Facco FL, Nathan N, et al. A review of the impact of obstetric anesthesia on maternal and neonatal outcomes. Anesthesiology 2018;129:192-215.

    BACKGROUND

  • 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.

    PMID: 28625307BACKGROUND

  • 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

    BACKGROUND

Study Officials

  • BETÜL YILMAZ, Specialist medical doctor

    Vezirkopru State Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
5 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2026

First Posted

March 24, 2026

Study Start

November 15, 2025

Primary Completion

November 15, 2025

Study Completion

March 15, 2026

Last Updated

March 24, 2026

Record last verified: 2026-03

Locations

TU(2)