Intrathecal Morphine vs Transversalis Fascia Plane Block After Cesarean Delivery

NCT07374133 | Completed

• 1 other identifier: CS-TFPB
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Cesarean Delivery; Postoperative Analgesia; Obstetric Anesthesia

Keywords

Cesarean Sections; Postoperative Pain; Analgesia; Ultrasonography, Interventional; Spinal Anesthesia

Outcome Measures

Primary Outcomes (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.

  Within the first 24 hours postoperatively

Secondary Outcomes (5)

• Postoperative Pain Intensity (NRS) at Rest

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

• Postoperative Pain Intensity (NRS) During Activity

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

• Postoperative Nausea and Vomiting (PONV) Severity Score

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

• Pruritus Severity Score

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

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

  24 and 48 hours postoperatively

Study Arms (1)

Elective Cesarean Delivery Cohort

This 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.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Giresun University Faculty of Medicine

Giresun, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 31255890 RESULT

• 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.

  PMID: 35223910 RESULT

• 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.

  PMID: 37480008 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• İlke TAMDOGAN

  Giresun University Faculty of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst.Prof.MD

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: January 28, 2026
• Study Start: February 1, 2026
• Primary Completion: March 15, 2026
• Study Completion: March 15, 2026
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)