Trial | NCT02804126  Report issue

Title

Comparison of Two Pain-treatment Techniques After Cesarean Section
Effectiveness of Transversus Abdominis Plane Block Versus Quadratus Lumborum Technique in Patients After Cesarean Section

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    232
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).
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.
Study Started
Jun 01
2017
Primary Completion
Jul 31
2018
Study Completion
Jul 31
2018
Last Update
Nov 28
2023

Procedure TAP (transversus abdominis plane block)

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).

Procedure QL (quadratus lumborum block)

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).

Drug Bupivacaine

In both groups (TAP&QL) 0.25% bupivacaine will be given (0.2 mL/kg)

Device Needle

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

Drug Paracetamol

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

Drug Metamizol

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

Drug Ketoprofen

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

Drug Morphine

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

TAP (transversus abdominis plane) Experimental

Ultrasound-guided transversus abdominis plane block at the end of cesarean section

QL (quadratus lumborum) Experimental

Ultrasound-guided quadratus lumborum block at the end of cesarean section

Criteria 

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
No Results Posted