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Regional Analgesia After Cesarean Section

Primary Purpose

Cesarean Section, Pain, Postoperative, Pain, Neuropathic

Status
Completed
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
TAP (transversus abdominis plane block)
QLB (quadratus lumborum block)
Stimuplex Ultra 360 needle
Ropivacaine
Paracetamol
subarachnoid anesthesia
PCA (patient controlled analgesia)
Metamizol
Ketoprofen
Bupivacaine
Sponsored by
Medical University of Lublin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cesarean Section focused on measuring postoperative 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 morphine and local anesthetics
  • depression, antidepressant drugs treatment
  • epilepsy
  • usage of painkiller before surgery
  • addiction to alcohol or recreational drugs

Sites / Locations

  • Szpital Specjalistyczny PRO-FAMILIA w Rzeszowie
  • Szpital Kliniczny Dzieciątka Jezus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

PCA

TAP

QLB

Arm Description

Subarchnoid anesthesia with bupivacaine PCA with morphine in the PACU

Subarchnoid anesthesia with bupivacaine 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 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section. PCA with morphine in the PACU

Subarchnoid anesthesia with bupivacaine QLB (quadratus lumborum block) ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section. PCA with morphine in the PACU

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)
Morphine consumption
Total morphine consumption

Full Information

First Posted
August 4, 2017
Last Updated
February 16, 2020
Sponsor
Medical University of Lublin
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1. Study Identification

Unique Protocol Identification Number
NCT03244540
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 4, 2017 (Actual)
Primary Completion Date
October 29, 2018 (Actual)
Study Completion Date
August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Lublin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section, Pain, Postoperative, Pain, Neuropathic
Keywords
postoperative 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
Model Description
Participants were randomized 1:1:1
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Participants, care providers, and assessors were not aware of type of the block
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PCA
Arm Type
Experimental
Arm Description
Subarchnoid anesthesia with bupivacaine PCA with morphine in the PACU
Arm Title
TAP
Arm Type
Experimental
Arm Description
Subarchnoid anesthesia with bupivacaine 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 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section. PCA with morphine in the PACU
Arm Title
QLB
Arm Type
Experimental
Arm Description
Subarchnoid anesthesia with bupivacaine QLB (quadratus lumborum block) ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section. PCA with morphine in the PACU
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
Intervention Type
Procedure
Intervention Name(s)
QLB (quadratus lumborum block)
Intervention Description
ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain
Intervention Type
Device
Intervention Name(s)
Stimuplex Ultra 360 needle
Intervention Description
ultrasound-guided needle will be used for QLB and TAP and regional blocks
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
0.375 % ropivacaine will be administered for both QLB and TAP (0.2 mL per kg on both sides)
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
Procedure
Intervention Name(s)
subarachnoid anesthesia
Intervention Description
subarachnoid anesthesia for each patients participating in the study with pencil point needle
Intervention Type
Procedure
Intervention Name(s)
PCA (patient controlled analgesia)
Intervention Description
All patients will receive PCA pump with morphine (1 mg/mL, 5 minute interval, no loading dose) after transfer to PACU (post-anesthesia care unit)
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)
Bupivacaine
Other Intervention Name(s)
Marcaine
Intervention Description
Subarachnoid anesthesia with spinal bupivacaine (MARCAINE SPINAL 0.5% HEAVY)
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
Title
Morphine consumption
Description
Total morphine consumption
Time Frame
up to 24 hours after surgery

10. Eligibility

Sex
Female
Gender Based
Yes
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 morphine and local anesthetics depression, antidepressant drugs treatment epilepsy usage of painkiller before surgery addiction to alcohol or recreational drugs
Facility Information:
Facility Name
Szpital Specjalistyczny PRO-FAMILIA w Rzeszowie
City
Rzeszów
ZIP/Postal Code
35-001
Country
Poland
Facility Name
Szpital Kliniczny Dzieciątka Jezus
City
Warszawa
ZIP/Postal Code
02-005
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
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
background
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
33800559
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.
Results Reference
derived

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Regional Analgesia After Cesarean Section

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