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Completed

NCT Number: NCT02804126

Comparison of Two Pain-treatment Techniques After Cesarean Section

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).

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Key information

Conditions

Cesarean Section Acute Pain Agnosia Nervous System Diseases Neuralgia Neurobehavioral Manifestations Neurologic Manifestations Neuromuscular Diseases Neuropathic Pain Pain Pain Management Pathological Conditions, Signs and Symptoms Perceptual Disorders Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

II Department of Anesthesia and Intensive Care

Lublin, 20-081, Poland

About this study

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.

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 anaesthesia

Exclusion criteria

  • coagulopathy
  • allergy to 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

ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.25% bupivacaine administered (0.2 mL/kg).

QL (quadratus lumborum block)

Procedure

ultrasound-guided regional block between abdominal wall muscles to treat acute pain, similar to transversus abdominis plane block, but with distribution of local anesthetic towards paravertebral space. Stimuplex Ultra 360 needle will be used and 0.25% bupivacaine administered (0.2 mL/kg).

Bupivacaine

Drug

In both groups (TAP&QL) 0.25% bupivacaine 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

Metamizol

Drug

Intravenous metamizol 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 measured with VAS

    Time frame: up to 24 hours after surgery

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

Secondary outcomes

  1. Neuropathic pain assessed with NPSI

    Time frame: 6 months from the surgery

    Neuropathic pain occurrence with Neuropathic Pain Symptom Inventory (NPSI)

Sponsors and collaborators

Lead sponsor

Michał Borys

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 17, 2016
Registry last updated
Nov 28, 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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