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Regional Analgesia After Cesarean Section

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03244540
Enrollment
105
Registered
2017-08-09
Start date
2017-09-04
Completion date
2019-08-30
Last updated
2020-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section, Pain, Postoperative, Pain, Neuropathic

Keywords

postoperative pain, transversus abdominis plane block, quadratus lumborum block, neuropathic pain

Brief summary

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).

Detailed description

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.

Interventions

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

PROCEDUREQLB (quadratus lumborum block)

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

DEVICEStimuplex Ultra 360 needle

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

DRUGRopivacaine

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

DRUGParacetamol

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

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

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)

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

DRUGKetoprofen

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

DRUGBupivacaine

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

Sponsors

Medical University of Lublin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

Participants, care providers, and assessors were not aware of type of the block

Intervention model description

Participants were randomized 1:1:1

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pain measured with VASup to 24 hours after surgeryAcute pain measured with VAS (visual-analogue scale)

Secondary

MeasureTime frameDescription
Neuropathic pain assessed with NPSI6 months from the surgeryNeuropathic pain occurrence with Neuropathic Pain Symptom Inventory (NPSI)
Morphine consumptionup to 24 hours after surgeryTotal morphine consumption

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026