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TAP vs QLB in Patients After Cesarean Delivery

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03404908
Enrollment
105
Registered
2018-01-19
Start date
2018-02-07
Completion date
2019-04-17
Last updated
2023-11-24

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

Conditions

Cesarean Section, Postoperative Pain

Keywords

transversus abdominis plane block, quadratus lumborum block, neuropathic pain

Brief summary

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).

Detailed description

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.

Interventions

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).

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).

DRUGRopivacaine

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

DEVICENeedle

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

DRUGparacetamol

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

Intravenous metamizole 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

DRUGMorphine

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

Sponsors

Medical University of Lublin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Single (Participant)

Intervention model description

Parallel Assignment

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative painup to 24 hours after the surgeryAcute 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

MeasureTime frameDescription
Neuropathic pain6 months from the surgeryNeuropathic 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.

Countries

Poland

Outcome results

None listed

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