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TAP vs QLB in Patients After Cesarean Delivery

M

Medical University of Lublin

Status and phase

Completed
Phase 4

Conditions

Postoperative Pain
Cesarean Section

Treatments

Drug: Ropivacaine
Procedure: QL (quadratus lumborum block)
Device: Needle
Drug: Ketoprofen
Drug: paracetamol
Drug: Morphine
Procedure: TAP (transversus abdominis plane block)
Drug: metamizole

Study type

Interventional

Funder types

Other

Identifiers

NCT03404908
KE-0254/238/2017

Details and patient eligibility

About

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).

Full 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.

Enrollment

105 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • obtained consent
  • singleton pregnancy
  • subarachnoid anesthesia

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

105 participants in 2 patient groups

TAP
Experimental group
Description:
Ultrasound-guided transversus abdominis plane block at the end of cesarean section
Treatment:
Drug: Morphine
Device: Needle
Procedure: TAP (transversus abdominis plane block)
Drug: Ropivacaine
Drug: paracetamol
Drug: Ketoprofen
Drug: metamizole
QLB
Experimental group
Description:
Ultrasound-guided quadratus lumborum block at the end of cesarean section
Treatment:
Drug: Morphine
Device: Needle
Drug: Ropivacaine
Procedure: QL (quadratus lumborum block)
Drug: paracetamol
Drug: Ketoprofen
Drug: metamizole

Trial contacts and locations

1

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Central trial contact

Paweł Piwowarczyk, M.D., PhD; Michał Borys, M.D., PhD

Data sourced from clinicaltrials.gov

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