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CompletedNCT02804126Updated Nov 28, 2023

Comparison of Two Pain-treatment Techniques After Cesarean Section

A Phase 4 interventional study of TAP (transversus abdominis plane block) and QL (quadratus lumborum block) in Cesarean Section, Pain Management and Neuropathic Pain, sponsored by Michał Borys. Completed at 1 site in Poland. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-11-28.

Sponsored by Michał Borys · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
232
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Female
01

Study summary

Comparison of two types of analgesia after cesarean section.

All patients will anaesthetised with spinal technique. Ultrasound-guided transversus abdominis plane or quadratus lumborum block to treat postoperative pain. Postoperative pain will measured with visual-analogue scale (VAS). 1, 2, 6 months after surgery each patient will be called to assess neuropathic pain with Neuropathic Pain Symptom Inventory (NPSI).

Read the detailed description

Written consent will be obtained before the cesarean section. Only subarachnoidally anaesthetised patients may participate in the study. Pencil-point spinal needle and bupivacaine (Marcaine Heavy Spinal 0.5 %) will be used.

At the end of surgery ultrasound-guided regional block will be performed. Each patient will be randomly allocated to one of the treated group: transversus abdominis plane block (TAP) or quadratus lumborum (QL). Patients receive 0.2 mL of local anesthetic solution (0.25 % bupivacaine) on each side.

Postoperative pain will be measured with VAS (visual-analogue scale) 2, 4, 8, 12 and 24 hours after the end of operation.

Paracetamol, metamizol, ketoprofen may be given as required. Whenever pain exceeds 40 (VAS) 5 mg of morphine will be given intravenously (maximum two dosages per day).

1, 3, 6 months patients will be called to assess neuropathic pain. Neuropathic Pain Symptom Inventory (NPSI) will be used.

02

Conditions studied

  • Cesarean Section
  • Pain Management
  • Neuropathic Pain

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Keywords

  • acute pain
  • transversus abdominis plane block
  • quadratus lumborum block
  • neuropathic pain
03

In context

Neuralgia

1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.

This study's enrollment of 232 is above the median of 52 across 973 interventional studies indexed under Neuralgia.

Browse Neuralgia studies →

Lead sponsor

This is the only study on the registry with Michał Borys as lead sponsor.

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

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • obtained consent
  • singleton pregnancy
  • subarachnoid anaesthesia

Exclusion criteria

Exclusion Criteria:

  • coagulopathy
  • allergy to to local anesthetics
  • depression, antidepressant drugs treatment
  • epilepsy
  • usage of painkiller before surgery
  • addiction to alcohol or recreational drugs
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
232 participants (actual)

Study arms

  • Experimental
    TAP (transversus abdominis plane)

    Ultrasound-guided transversus abdominis plane block at the end of cesarean section

    Procedure: TAP (transversus abdominis plane block) · Drug: Bupivacaine · Device: Needle · Drug: Paracetamol · Drug: Metamizol · Drug: Ketoprofen · Drug: Morphine

  • Experimental
    QL (quadratus lumborum)

    Ultrasound-guided quadratus lumborum block at the end of cesarean section

    Procedure: QL (quadratus lumborum block) · Drug: Bupivacaine · Device: Needle · Drug: Paracetamol · Drug: Metamizol · Drug: Ketoprofen · Drug: Morphine

Interventions

  • ProcedureTAP (transversus abdominis plane block)

    ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.25% bupivacaine administered (0.2 mL/kg).

  • ProcedureQL (quadratus lumborum block)

    ultrasound-guided regional block between abdominal wall muscles to treat acute pain, similar to transversus abdominis plane block, but with distribution of local anesthetic towards paravertebral space. Stimuplex Ultra 360 needle will be used and 0.25% bupivacaine administered (0.2 mL/kg).

  • DrugBupivacaine

    In both groups (TAP\&QL) 0.25% bupivacaine will be given (0.2 mL/kg)

  • DeviceNeedle

    Ultrasound-guided, Stimuplex ultra 360 needle will be used in the study

  • DrugParacetamol

    Intravenous paracetamol will be used (1.0 gram), up to 4 grams per day

  • DrugMetamizol

    Intravenous metamizol will be used (1.0 gram), up to 4 grams per day

  • DrugKetoprofen

    Intravenous ketoprofen will be used (0.1 gram), up to 200 milligrams per day

  • DrugMorphine

    Intravenous morphine (5 mg) will be given when pain exceeds 40 mm in VAS (maximum 2 doses per day)

06

What researchers measure

Primary outcomes

  1. Postoperative pain measured with VAS

    Acute pain measured with VAS (visual-analogue scale).

    Time frame: up to 24 hours after surgery

Secondary outcomes

  1. Neuropathic pain assessed with NPSI

    Neuropathic pain occurrence with Neuropathic Pain Symptom Inventory (NPSI)

    Time frame: 6 months from the surgery

07

Study locations

1 site
  • II Department of Anesthesia and Intensive Care
    Lublin, 20-081, Poland
08

References and documents

Publications

  • Kadam VR. Ultrasound-guided quadratus lumborum block as a postoperative analgesic technique for laparotomy. J Anaesthesiol Clin Pharmacol. 2013 Oct;29(4):550-2. doi: 10.4103/0970-9185.119148. PubMed 24249997 ↗
  • Kadam VR. Ultrasound guided quadratus lumborum block or posterior transversus abdominis plane block catheter infusion as a postoperative analgesic technique for abdominal surgery. J Anaesthesiol Clin Pharmacol. 2015 Jan-Mar;31(1):130-1. doi: 10.4103/0970-9185.150575. No abstract available. PubMed 25788791 ↗
  • Kanazi GE, Aouad MT, Abdallah FW, Khatib MI, Adham AM, Harfoush DW, Siddik-Sayyid SM. The analgesic efficacy of subarachnoid morphine in comparison with ultrasound-guided transversus abdominis plane block after cesarean delivery: a randomized controlled trial. Anesth Analg. 2010 Aug;111(2):475-81. doi: 10.1213/ANE.0b013e3181e30b9f. Epub 2010 May 20. PubMed 20488929 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02804126
Lead sponsor
Michał Borys
Responsible party
Michał Borys (associate professor, Medical University of Lublin) — Sponsor-investigator
First posted
Jun 17, 2016
Start date
Jun 1, 2017
Primary completion
Jul 31, 2018
Completion
Jul 31, 2018
Last update
Nov 28, 2023

Study contacts

Miroslaw Czuczwar, MD, PhD
study chair · II Department of Anesthesiology and Intensive Care Medial University of Lublin

Oversight

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

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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