Comparison of Two Pain-treatment Techniques After Cesarean Section

Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02804126
• Other study ID #: KE-0254/85/2016
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2017
• Est. completion date: July 31, 2018

Study information

• Verified date: November 2023
• Source: Medical University of Lublin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section
• Neuralgia
• Neuropathic Pain
• Pain Management

Intervention

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).
• 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
• Metamizol
Intravenous metamizol will be used (1.0 gram), up to 4 grams per day
• Ketoprofen
Intravenous ketoprofen will be used (0.1 gram), up to 200 milligrams per day
• Morphine
Intravenous morphine (5 mg) will be given when pain exceeds 40 mm in VAS (maximum 2 doses per day)

Locations

Country	Name	City	State
Poland	II Department of Anesthesia and Intensive Care	Lublin

Sponsors (1)

Lead Sponsor	Collaborator
Michal Borys

Country where clinical trial is conducted

Poland, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain measured with VAS	Acute pain measured with VAS (visual-analogue scale).	up to 24 hours after surgery
Secondary	Neuropathic pain assessed with NPSI	Neuropathic pain occurrence with Neuropathic Pain Symptom Inventory (NPSI)	6 months from the surgery