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Completed

NCT Number: NCT03404908

TAP vs QLB in Patients After Cesarean Delivery

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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Key information

Conditions

Cesarean Section Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

II Department of Anesthesia and Intensive Care, Medical University of Lublin

Lublin, 20-081, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. 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

  1. Neuropathic pain

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medical University of Lublin

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 19, 2018
Registry last updated
Nov 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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