Clinical trial

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

Name

KE-0254/238/2017

Description

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).

Trial arms

Trial start

2018-02-07

Estimated PCD

2019-01-14

Trial end

2019-04-17

Status

Completed

Phase

Early phase I

Treatment

TAP (transversus abdominis plane block)

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).

Arms:

TAP

QL (quadratus lumborum block)

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).

Arms:

QLB

Ropivacaine

In both groups (TAP\&QLB) 0.375% ropivacaine will be given (0.2 mL/kg)

Arms:

QLB, TAP

Needle

Ultrasound-guided, Stimuplex ultra 360 needle will be used in the study

Arms:

QLB, TAP

paracetamol

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

Arms:

QLB, TAP

metamizole

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

Arms:

QLB, TAP

Ketoprofen

Intravenous ketoprofen will be used (0.1 gram), up to 200 milligrams per day

Arms:

QLB, TAP

Morphine

Intravenous morphine (5 mg) will be given when pain exceeds 40 mm in VAS (maximum 2 doses per day)

Arms:

QLB, TAP

Size

105

Primary endpoint

Postoperative pain

up to 24 hours after the surgery

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Single (Participant)', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 105, 'type': 'ACTUAL'}}

Updated at

2023-11-24

1 organization

5 products

2 indications

Organization

Medical University of Lublin

Product

Ropivacaine

Indication

c-section

Indication