TAP vs QLB in Patients After Cesarean Delivery

Postoperative Analgesia With Transversus Abdominis Plane Block or Quadratus Lumborum Block in Patients After Cesarian Delivery

Comparison of two types of analgesia after cesarean section All patients will be anesthetized with spinal technique. Ultrasound-guided transversus abdominis plane or quadratus lumborum block to treat postoperative pain. Postoperative pain will be measured with visual-analog 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: Unknown
• Conditions: Postoperative Pain; Cesarean Section
• Intervention / Treatment: Procedure: TAP (transversus abdominis plane block); Drug: Ropivacaine; Device: Needle; Drug: paracetamol; Drug: metamizole; Drug: Ketoprofen; Drug: Morphine; Procedure: QL (quadratus lumborum block)

Detailed Description

Written consent will be obtained before the cesarean section. Only subarachnoidally anesthetized 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 (0.375 % ropivacaine) on each side.

Postoperative pain will be measured with VAS (visual-analog scale) 2, 4, 8, 12 and 24 hours after the end of the operation.

Paracetamol, metamizole, 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 (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• obtained consent
• singleton pregnancy
• subarachnoid anesthesia

Exclusion Criteria:

• coagulopathy
• allergy 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; Ultrasound-guided transversus abdominis plane block at the end of cesarean section	Procedure: TAP (transversus abdominis plane block); the ultrasound-guided regional block of abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375% ropivacaine administered (0.2 mL/kg).; Drug: Ropivacaine; In both groups (TAP&QLB) 0.375% ropivacaine 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: metamizole; Intravenous metamizole 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)
Experimental: QLB; Ultrasound-guided quadratus lumborum block at the end of cesarean section	Drug: Ropivacaine; In both groups (TAP&QLB) 0.375% ropivacaine 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: metamizole; Intravenous metamizole 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); Procedure: QL (quadratus lumborum block); the ultrasound-guided regional block of abdominal wall muscles to treat acute pain, similar to transversus abdominis plane block, but with a 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	Acute pain measured with VAS (visual-analogue scale). VAS in milimmeters. Minimum value 0, maximum 100. Less better - less severe pain. 0 no pain at all.	up to 24 hours after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuropathic pain	Neuropathic pain occurrence assessed with Neuropathic Pain Symptom Inventory (NPSI) 10 descriptive variables, each one from 0 to 10. 0 means no pain. 10 very high chance of occurrence of neuropathic pain.	6 months from the surgery

Collaborators and Investigators

• Sponsor: Medical University of Lublin
• Investigators: Study Chair: Mirosław Czuczwar, M.D., PhD, Medical University of Lublin

Study record dates

Study Major Dates

• Study Start (Anticipated): February 7, 2018
• Primary Completion (Anticipated): January 14, 2019
• Study Completion (Anticipated): April 17, 2019

Study Registration Dates

• First Submitted: January 12, 2018
• First Submitted That Met QC Criteria: January 12, 2018
• First Posted (Actual): January 19, 2018

Study Record Updates

• Last Update Posted (Actual): January 23, 2018
• Last Update Submitted That Met QC Criteria: January 19, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: transversus abdominis plane block; neuropathic pain; quadratus lumborum block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; 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; Ropivacaine; Morphine; Ketoprofen; Dipyrone
• Other Study ID Numbers: KE-0254/238/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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