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Clinical Trials/NCT02804126
NCT02804126
Completed
Phase 4

Effectiveness of Transversus Abdominis Plane Block Versus Quadratus Lumborum Technique in Patients After Cesarean Section

Michał Borys1 site in 1 country232 target enrollmentJune 1, 2017

Overview

Phase
Phase 4
Intervention
TAP (transversus abdominis plane block)
Conditions
Cesarean Section
Sponsor
Michał Borys
Enrollment
232
Locations
1
Primary Endpoint
Postoperative pain measured with VAS
Status
Completed
Last Updated
2 years ago

Overview

Brief 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).

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2017
End Date
July 31, 2018
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Michał Borys
Responsible Party
Sponsor Investigator
Principal Investigator

Michał Borys

associate professor

Medical University of Lublin

Eligibility Criteria

Inclusion Criteria

  • obtained consent
  • singleton pregnancy
  • subarachnoid anaesthesia

Exclusion Criteria

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

Arms & Interventions

TAP (transversus abdominis plane)

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

Intervention: TAP (transversus abdominis plane block)

TAP (transversus abdominis plane)

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

Intervention: Needle

TAP (transversus abdominis plane)

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

Intervention: Bupivacaine

TAP (transversus abdominis plane)

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

Intervention: Paracetamol

TAP (transversus abdominis plane)

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

Intervention: Metamizol

TAP (transversus abdominis plane)

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

Intervention: Ketoprofen

TAP (transversus abdominis plane)

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

Intervention: Morphine

QL (quadratus lumborum)

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

Intervention: QL (quadratus lumborum block)

QL (quadratus lumborum)

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

Intervention: Bupivacaine

QL (quadratus lumborum)

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

Intervention: Needle

QL (quadratus lumborum)

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

Intervention: Paracetamol

QL (quadratus lumborum)

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

Intervention: Metamizol

QL (quadratus lumborum)

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

Intervention: Ketoprofen

QL (quadratus lumborum)

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

Intervention: Morphine

Outcomes

Primary Outcomes

Postoperative pain measured with VAS

Time Frame: up to 24 hours after surgery

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

Secondary Outcomes

  • Neuropathic pain assessed with NPSI(6 months from the surgery)

Study Sites (1)

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