Comparison of Two Pain-treatment Techniques After Cesarean Section

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

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).

Study Overview

• Status: Completed
• Conditions: Cesarean Section; Pain Management; Neuropathic Pain
• Intervention / Treatment: Device: Needle; Drug: Ketoprofen; Drug: Morphine; Procedure: TAP (transversus abdominis plane block); Drug: Bupivacaine; Drug: Paracetamol; Drug: Metamizol; Procedure: QL (quadratus lumborum block)

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.

• Study Type: Interventional
• Enrollment (Actual): 232
• Phase: Phase 4

Contacts and Locations

Study Locations

• Poland
  • Lublin, Poland, 20-081
    • II Department of Anesthesia and Intensive Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAP (transversus abdominis plane); Ultrasound-guided transversus abdominis plane block at the end of cesarean section	Device: Needle; Ultrasound-guided, Stimuplex ultra 360 needle will be used in the study; 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); 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).; Drug: Bupivacaine; In both groups (TAP&QL) 0.25% bupivacaine will be given (0.2 mL/kg); 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
Experimental: QL (quadratus lumborum); Ultrasound-guided quadratus lumborum block at the end of cesarean section	Device: Needle; Ultrasound-guided, Stimuplex ultra 360 needle will be used in the study; 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); Drug: Bupivacaine; In both groups (TAP&QL) 0.25% bupivacaine will be given (0.2 mL/kg); 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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain measured with VAS	Acute pain measured with VAS (visual-analogue scale).	up to 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuropathic pain assessed with NPSI	Neuropathic pain occurrence with Neuropathic Pain Symptom Inventory (NPSI)	6 months from the surgery

Collaborators and Investigators

• Sponsor: Michał Borys
• Investigators: Study Chair: Miroslaw Czuczwar, MD, PhD, II Department of Anesthesiology and Intensive Care Medial University of Lublin

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: June 8, 2016
• First Submitted That Met QC Criteria: June 16, 2016
• First Posted (Estimated): June 17, 2016

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 22, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: acute pain; transversus abdominis plane block; neuropathic pain; quadratus lumborum block
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Acetaminophen; Bupivacaine; Morphine; Ketoprofen; Dipyrone
• Other Study ID Numbers: KE-0254/85/2016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No