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Completed

NCT Number: NCT07490795

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

  2. 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)

  3. 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

    • Nause without vomiting
    • One episode of vomiting
    • More than one episode of vomiting
  4. 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

    • Mild pruritis (sensation without need to scratch)
    • Moderate pruritis ( requires scratching)
    • Severe pruritis (requires treatment)
  5. 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.

Sponsors and collaborators

Lead sponsor

Vezirköprü State Hospital

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Mar 24, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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