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Comparison of Two Pain-treatment Techniques After Cesarean Section

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02804126
Enrollment
232
Registered
2016-06-17
Start date
2017-06-01
Completion date
2018-07-31
Last updated
2023-11-28

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

Conditions

Cesarean Section, Pain Management, Neuropathic Pain

Keywords

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

Brief summary

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).

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. 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.

Interventions

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).

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).

DRUGBupivacaine

In both groups (TAP&QL) 0.25% bupivacaine 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 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

DRUGMorphine

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

Sponsors

Michał Borys
Lead SponsorOTHER

Study design

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

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 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 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)

Countries

Poland

Outcome results

None listed

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