Clinical trial NCT02804126: Comparison of Two Pain-treatment Techniques After Cesarean Section
Official title: Effectiveness of Transversus Abdominis Plane Block Versus Quadratus Lumborum Technique in Patients After Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cesarean Section
Pain Management
Neuropathic Pain
Keywords: acute pain
transversus abdominis plane block
quadratus lumborum block
neuropathic pain
Lead sponsor: Medical University of Lublin
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 232
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Postoperative pain measured with VAS
timeFrame: up to 24 hours after surgery
Secondary outcomes:
measure: Neuropathic pain assessed with NPSI
timeFrame: 6 months from the surgery
Other outcomes:
Locations:
city: Lublin
country: Poland
facility: II Department of Anesthesia and Intensive Care
Study officials:
affiliation: II Department of Anesthesiology and Intensive Care Medial University of Lublin
name: Miroslaw Czuczwar, MD, PhD
role: STUDY_CHAIR
References:
citation: Kadam VR. Ultrasound-guided quadratus lumborum block as a postoperative analgesic technique for laparotomy. J Anaesthesiol Clin Pharmacol. 2013 Oct;29(4):550-2. doi: 10.4103/0970-9185.119148.
citation: Kadam VR. Ultrasound guided quadratus lumborum block or posterior transversus abdominis plane block catheter infusion as a postoperative analgesic technique for abdominal surgery. J Anaesthesiol Clin Pharmacol. 2015 Jan-Mar;31(1):130-1. doi: 10.4103/0970-9185.150575. No abstract available.
citation: Kanazi GE, Aouad MT, Abdallah FW, Khatib MI, Adham AM, Harfoush DW, Siddik-Sayyid SM. The analgesic efficacy of subarachnoid morphine in comparison with ultrasound-guided transversus abdominis plane block after cesarean delivery: a randomized controlled trial. Anesth Analg. 2010 Aug;111(2):475-81. doi: 10.1213/ANE.0b013e3181e30b9f. Epub 2010 May 20.