Clinical trial NCT03244540: Regional Analgesia After Cesarean Section
Official title: Efficacy of Regional Analgesia Techniques (Quadratus Lumborum Block and Transversus Abdominis Plane Block) in Acute and Chronic Pain Treatment in Patients After Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cesarean Section
Pain, Postoperative
Pain, Neuropathic
Keywords: postoperative pain
transversus abdominis plane block
quadratus lumborum block
neuropathic pain
Lead sponsor: Medical University of Lublin
Sponsor class: OTHER
First posted: 2017-08-09
Enrollment: 105
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were randomized 1:1:1
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

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
measure: Morphine consumption
timeFrame: up to 24 hours after surgery
Other outcomes:
Locations:
city: Rzeszów
country: Poland
facility: Szpital Specjalistyczny PRO-FAMILIA w Rzeszowie
city: Warszawa
country: Poland
facility: Szpital Kliniczny Dzieciątka Jezus
Study officials:
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: Borys M, Zamaro A, Horeczy B, Geszka E, Janiak M, Wegrzyn P, Czuczwar M, Piwowarczyk P. Quadratus Lumborum and Transversus Abdominis Plane Blocks and Their Impact on Acute and Chronic Pain in Patients after Cesarean Section: A Randomized Controlled Study. Int J Environ Res Public Health. 2021 Mar 28;18(7):3500. doi: 10.3390/ijerph18073500.