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TAP vs QLB in Patients After Cesarean Delivery

NCT03404908 — Phase 4, Completed, 105 participants, Medical University of Lublin

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

RegistryNCT03404908
StatusCompleted
PhasePhase 4
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment105 (Actual)
SponsorMedical University of Lublin (Other)
ConditionsCesarean Section, Postoperative Pain
InterventionsTAP (transversus abdominis plane block), QL (quadratus lumborum block), Ropivacaine, Needle, paracetamol, metamizole, Ketoprofen, Morphine (Procedure, drug, device)
Datesstart 2018-02-07, primary completion 2019-01-14, completion 2019-04-17, first posted 2018-01-19, last updated 2023-11-24
Locations1 site in Poland

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-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).

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
TAPExperimentalProcedure: TAP (transversus abdominis plane block); Drug: Ropivacaine; Device: Needle; Drug: paracetamol; Drug: metamizole; Drug: Ketoprofen; Drug: MorphineUltrasound-guided transversus abdominis plane block at the end of cesarean section
QLBExperimentalProcedure: QL (quadratus lumborum block); Drug: Ropivacaine; Device: Needle; Drug: paracetamol; Drug: metamizole; Drug: Ketoprofen; Drug: MorphineUltrasound-guided quadratus lumborum block at the end of cesarean section
  • TAP (transversus abdominis plane block) (Procedure): the ultrasound-guided regional block of abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375% ropivacaine administered (0.2 mL/kg).
  • QL (quadratus lumborum block) (Procedure): the ultrasound-guided regional block of abdominal wall muscles to treat acute pain, similar to transversus abdominis plane block, but with a distribution of local anesthetic towards paravertebral space. Stimuplex Ultra 360 needle will be used and 0.25% bupivacaine administered (0.2 mL/kg).
  • Ropivacaine (Drug): In both groups (TAP\&QLB) 0.375% ropivacaine will be given (0.2 mL/kg)
  • Needle (Device): Ultrasound-guided, Stimuplex ultra 360 needle will be used in the study
  • paracetamol (Drug): Intravenous paracetamol will be used (1.0 gram), up to 4 grams per day
  • metamizole (Drug): Intravenous metamizole will be used (1.0 gram), up to 4 grams per day
  • Ketoprofen (Drug): Intravenous ketoprofen will be used (0.1 gram), up to 200 milligrams per day
  • Morphine (Drug): Intravenous morphine (5 mg) will be given when pain exceeds 40 mm in VAS (maximum 2 doses per day)

+Outcome measures

Primary outcomes

  • Postoperative pain [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]: Neuropathic pain occurrence assessed with Neuropathic Pain Symptom Inventory (NPSI) 10 descriptive variables, each one from 0 to 10. 0 means no pain. 10 very high chance of occurrence of neuropathic pain.

+Eligibility

Sex: Female, ages: 18 Years to 70 Years

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

+Locations (1)

FacilityCityCountryStatus
II Department of Anesthesia and Intensive Care, Medical University of LublinLublinPoland

+Investigators

  • MirosÅ‚aw Czuczwar, M.D., PhD, Study chair, Medical University of Lublin

My Notes