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Comparison of Two Pain-treatment Techniques After Cesarean Section

Primary Purpose

Cesarean Section, Pain Management, Neuropathic Pain

Status
Unknown status
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
TAP (transversus abdominis plane block)
QL (quadratus lumborum block)
Bupivacaine
Needle
Paracetamol
Metamizol
Ketoprofen
Morphine
Sponsored by
Michał Borys
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cesarean Section focused on measuring acute pain, transversus abdominis plane block, quadratus lumborum block, neuropathic pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • II Department of Anesthesia and Intensive CareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

TAP (transversus abdominis plane)

QL (quadratus lumborum)

Arm Description

Ultrasound-guided transversus abdominis plane block at the end of cesarean section

Ultrasound-guided quadratus lumborum block at the end of cesarean section

Outcomes

Primary Outcome Measures

Postoperative pain measured with VAS
Acute pain measured with VAS (visual-analogue scale).

Secondary Outcome Measures

Neuropathic pain assessed with NPSI
Neuropathic pain occurrence with Neuropathic Pain Symptom Inventory (NPSI)

Full Information

First Posted
June 8, 2016
Last Updated
May 1, 2017
Sponsor
Michał Borys
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1. Study Identification

Unique Protocol Identification Number
NCT02804126
Brief Title
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

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
November 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michał Borys

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section, Pain Management, Neuropathic Pain
Keywords
acute pain, transversus abdominis plane block, quadratus lumborum block, neuropathic pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAP (transversus abdominis plane)
Arm Type
Experimental
Arm Description
Ultrasound-guided transversus abdominis plane block at the end of cesarean section
Arm Title
QL (quadratus lumborum)
Arm Type
Experimental
Arm Description
Ultrasound-guided quadratus lumborum block at the end of cesarean section
Intervention Type
Procedure
Intervention Name(s)
TAP (transversus abdominis plane block)
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
QL (quadratus lumborum block)
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
In both groups (TAP&QL) 0.25% bupivacaine will be given (0.2 mL/kg)
Intervention Type
Device
Intervention Name(s)
Needle
Intervention Description
Ultrasound-guided, Stimuplex ultra 360 needle will be used in the study
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Intervention Description
Intravenous paracetamol will be used (1.0 gram), up to 4 grams per day
Intervention Type
Drug
Intervention Name(s)
Metamizol
Intervention Description
Intravenous metamizol will be used (1.0 gram), up to 4 grams per day
Intervention Type
Drug
Intervention Name(s)
Ketoprofen
Intervention Description
Intravenous ketoprofen will be used (0.1 gram), up to 200 milligrams per day
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
Intravenous morphine (5 mg) will be given when pain exceeds 40 mm in VAS (maximum 2 doses per day)
Primary Outcome Measure Information:
Title
Postoperative pain measured with VAS
Description
Acute pain measured with VAS (visual-analogue scale).
Time Frame
up to 24 hours after surgery
Secondary Outcome Measure Information:
Title
Neuropathic pain assessed with NPSI
Description
Neuropathic pain occurrence with Neuropathic Pain Symptom Inventory (NPSI)
Time Frame
6 months from the surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michal Borys, MD, PhD
Phone
+48 81532 2713
Email
michalborys@umlub.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miroslaw Czuczwar, MD, PhD
Organizational Affiliation
II Department of Anesthesiology and Intensive Care Medial University of Lublin
Official's Role
Study Chair
Facility Information:
Facility Name
II Department of Anesthesia and Intensive Care
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michał Borys, M.D. Ph.D
Phone
506350569
Email
michalborys1@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
24249997
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.
Results Reference
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PubMed Identifier
25788791
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.
Results Reference
background
PubMed Identifier
20488929
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.
Results Reference
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Comparison of Two Pain-treatment Techniques After Cesarean Section

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