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CompletedNCT06425718Updated Aug 22, 2024

Comparison of Postoperative Analgesia Methods in Elective Cesarean Section Surgeries

An interventional study of Postoperative Pain Management Technique in Opioid Use and Postoperative Pain, sponsored by Marmara University. Completed at 1 site in Turkey. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-22.

Sponsored by Marmara University · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

Since many intravenous anesthetic agents administered to the mother can cross the placental barrier and cause fetal side effects, multimodal analgesia strategies with peripheral nerve blocks are preffered with greater safety in elective Cesarean section surgeries.

The primary objective of this study is to compare postoperative opioid consumption and pain scores (NRS) in elective cesarean section patients who receive a transversalis fascia plane block versus those who receive surgical site local anesthetic infiltration in addition to spinal anesthesia.

Read the detailed description

After Cesarean sections, several factors play a role in the formation of postoperative pain, including parietal stimulation originating from the surgical incision, visceral stimulation originating from the peritoneum, and manipulation of intra-abdominal structures.

To enhance patients' rehabilitation during the postoperative period, promote lactation and infant care, and reduce hospital stays, the most appropriate postoperative analgesia method should be selected.

Since many intravenous anesthetic agents administered to the mother can cross the placental barrier and cause fetal side effects, regional anesthesia techniques are preferred with greater safety in elective Cesarean section surgeries.

In the postoperative period, multimodal analgesia strategies can be used for pain control, and one of these strategies is postoperative peripheral nerve blocks. Ultrasound guided transversalis fascia plane block is one of the preferred methods for postoperative analgesia in cesarean section patients.

The primary objective of this study is to compare postoperative opioid consumption and pain scores (NRS) in elective cesarean section patients who receive a transversalis plane block versus those who receive surgical site local anesthetic infiltration in addition to spinal anesthesia.

02

Conditions studied

  • Opioid Use
  • Postoperative Pain

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Keywords

  • opioid use
  • postoperative pain
  • transversalis plane block
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 42 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Marmara University is the lead sponsor of 576 studies on the registry; 136 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Patients over 18 years old
  • ASA II-III patients undergoing elective cesarean section

Exclusion criteria

Exclusion Criteria:

  • ASA IV patients
  • Patients with known neurologic or psychiatric disorders
  • Patients with clinically significant cardiovascular, respiratory, hepatic, renal or metabolic disease
  • Patients with alcohol or drug addiction
  • Mentally disabled patients
  • Patients with BMI>30
  • Patients who develop massive bleeding or coagulopathy
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
42 participants (actual)

Study arms

  • Active comparator
    Transversalis Fascia Plane Block

    Bilateral Transversalis Fascia Plane Block (with %0.25 bupivacaine, 20 ml for each side) and intravenous tramadol via Patient Controlled Analgesia device (5 mg/ml tramadol, bolus dose: 1ml, lock time: 10 minutes)

    Procedure: Postoperative Pain Management Technique

  • Active comparator
    Surgical Site Local Anesthetic Infiltration

    Local anesthetic infiltration will be applied to the surgical incision area with 0.25% 20 ml bupivacaine and intravenous tramadol via Patient Controlled Analgesia device (5 mg/ml tramadol, bolus dose: 1ml, lock time: 10 minutes)

    Procedure: Postoperative Pain Management Technique

Interventions

  • ProcedurePostoperative Pain Management Technique

    Patients who will undergo cesarean section under spinal anesthesia will be included. Comparing postoperative pain and opioid consumption in groups

06

What researchers measure

Primary outcomes

  1. Comparison of postoperative opioid consumption between two groups via Patient Controlled Analgesia (PCA) device

    Intravenous patient-controlled analgesia (PCA) is a system of opioid delivery that consists of an infusion pump interfaced with a timing device. Intravenous tramadol consumption will be recorded via PCA device, then it will be documented in mg/kg units.

    Time frame: 24 hours

Secondary outcomes

  1. Postoperative pain assessment with Numeric Rating Scale (NRS)

    In a Numerical Rating Scale (NRS), patients are asked to choose from 1 to 10. 1: no pain 10: worst pain experienced

    Time frame: 24 hours

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Study locations

1 site
  • Marmara University Pendik Education and Research Hospital
    Istanbul, 34899, Turkey
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06425718
Lead sponsor
Marmara University
Responsible party
Sponsor
First posted
May 22, 2024
Start date
May 15, 2024
Primary completion
Jun 26, 2024
Completion
Jun 26, 2024
Last update
Aug 22, 2024

Study contacts

Beliz Bilgili
principal investigator · Marmara University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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