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NCT Number: NCT03244540

Regional Analgesia After Cesarean Section

All patients will be anaesthetized with spinal technique. Each patient will be treated with intravenous morphine - patient controlled analgesia (PCA). 2 of 3 groups of patients will receive ultrasound-guided transversus abdominis plane or quadratus lumborum block to treat postoperative pain. Postoperative pain will measured with visual-analogue scale (VAS). Total morphine consumption and time to the first demand will be noted. 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, Neuropathic Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Postoperative Complications Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Szpital Specjalistyczny PRO-FAMILIA w Rzeszowie, Rzeszów, Poland

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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.

All patients will receive PCA (patient controlled analgesia) pump with morphine (1 mg/mL, 5 minute interval, no loading dose) after transfer to PACU (post-anesthesia care unit). In PACU vital signs will be monitored.

Each patient will be randomly assigned to one of three groups. In the first group of patients no additional regional analgesia will be performed. In the second and the third group, ultrasound-guided transversus abdominis plane or quadratus lumborum block will be done with 0.375 % ropivacaine (0.2 ml per kg 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.

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 morphine and 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

QLB (quadratus lumborum block)

Procedure

ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain

Stimuplex Ultra 360 needle

Device

ultrasound-guided needle will be used for QLB and TAP and regional blocks

Ropivacaine

Drug

0.375 % ropivacaine will be administered for both QLB and TAP (0.2 mL per kg on both sides)

Paracetamol

Drug

Intravenous paracetamol will be used (1.0 gram), up to 4 grams per day

subarachnoid anesthesia

Procedure

subarachnoid anesthesia for each patients participating in the study with pencil point needle

PCA (patient controlled analgesia)

Procedure

All patients will receive PCA pump with morphine (1 mg/mL, 5 minute interval, no loading dose) after transfer to PACU (post-anesthesia care unit)

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

Bupivacaine

Drug

Subarachnoid anesthesia with spinal bupivacaine (MARCAINE SPINAL 0.5% HEAVY)

Other names: Marcaine

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)

  2. Morphine consumption

    Time frame: up to 24 hours after surgery

    Total morphine consumption

Sponsors and collaborators

Lead sponsor

Medical University of Lublin

Other

Registry information

Official study title

Efficacy of Regional Analgesia Techniques (Quadratus Lumborum Block and Transversus Abdominis Plane Block) in Acute and Chronic Pain Treatment in Patients After Cesarean Delivery

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Aug 9, 2017
Registry last updated
Feb 18, 2020

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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