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Clinical Trials/NCT03404908
NCT03404908
Completed
Phase 4

Postoperative Analgesia With Transversus Abdominis Plane Block or Quadratus Lumborum Block in Patients After Cesarian Delivery

Medical University of Lublin1 site in 1 country105 target enrollmentFebruary 7, 2018

Overview

Phase
Phase 4
Intervention
Morphine
Conditions
Cesarean Section
Sponsor
Medical University of Lublin
Enrollment
105
Locations
1
Primary Endpoint
Postoperative pain
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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

Detailed Description

Written consent will be obtained before the cesarean section. Only subarachnoidally anesthetized 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 (0.375 % ropivacaine) on each side. Postoperative pain will be measured with VAS (visual-analog scale) 2, 4, 8, 12 and 24 hours after the end of the operation. Paracetamol, metamizole, 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.

Registry
clinicaltrials.gov
Start Date
February 7, 2018
End Date
April 17, 2019
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michał Borys

associate professor

Medical University of Lublin

Eligibility Criteria

Inclusion Criteria

  • obtained consent
  • singleton pregnancy
  • subarachnoid anesthesia

Exclusion Criteria

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

Arms & Interventions

TAP

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

Intervention: Morphine

TAP

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

Intervention: TAP (transversus abdominis plane block)

TAP

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

Intervention: Ropivacaine

TAP

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

Intervention: Needle

TAP

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

Intervention: paracetamol

TAP

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

Intervention: metamizole

TAP

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

Intervention: Ketoprofen

QLB

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

Intervention: QL (quadratus lumborum block)

QLB

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

Intervention: Ropivacaine

QLB

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

Intervention: Needle

QLB

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

Intervention: paracetamol

QLB

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

Intervention: metamizole

QLB

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

Intervention: Ketoprofen

QLB

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

Intervention: Morphine

Outcomes

Primary Outcomes

Postoperative pain

Time Frame: up to 24 hours after the surgery

Acute pain measured with VAS (visual-analogue scale). VAS in milimmeters. Minimum value 0, maximum 100. Less better - less severe pain. 0 no pain at all.

Secondary Outcomes

  • Neuropathic pain(6 months from the surgery)

Study Sites (1)

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