Regional Analgesia After Cesarean Section

NCT03244540 | Completed Phase 4

• 1 other identifier: KE-0254/127/2017
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 2

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).

Conditions

Cesarean Section; Pain, Postoperative; Pain, Neuropathic

Keywords

postoperative pain; transversus abdominis plane block; quadratus lumborum block; neuropathic pain

Outcome Measures

Primary Outcomes (1)

• Postoperative pain measured with VAS

  Acute pain measured with VAS (visual-analogue scale)

  up to 24 hours after surgery

Secondary Outcomes (2)

• Neuropathic pain assessed with NPSI

  6 months from the surgery

• Morphine consumption

  up to 24 hours after surgery

Study Arms (3)

PCA

EXPERIMENTAL

Subarchnoid anesthesia with bupivacaine PCA with morphine in the PACU

Drug: Paracetamol; Procedure: subarachnoid anesthesia; Procedure: PCA (patient controlled analgesia); Drug: Metamizol; Drug: Ketoprofen; Drug: Bupivacaine

TAP

EXPERIMENTAL

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

Procedure: TAP (transversus abdominis plane block); Device: Stimuplex Ultra 360 needle; Drug: Ropivacaine; Drug: Paracetamol; Procedure: subarachnoid anesthesia; Procedure: PCA (patient controlled analgesia); Drug: Metamizol; Drug: Ketoprofen; Drug: Bupivacaine

QLB

EXPERIMENTAL

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

Procedure: QLB (quadratus lumborum block); Device: Stimuplex Ultra 360 needle; Drug: Ropivacaine; Drug: Paracetamol; Procedure: subarachnoid anesthesia; Procedure: PCA (patient controlled analgesia); Drug: Metamizol; Drug: Ketoprofen; Drug: Bupivacaine

Interventions

TAP (transversus abdominis plane block) PROCEDURE

ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain

TAP

QLB (quadratus lumborum block) PROCEDURE

ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain

QLB

Stimuplex Ultra 360 needle DEVICE

ultrasound-guided needle will be used for QLB and TAP and regional blocks

QLB; TAP

Ropivacaine DRUG

0.375 % ropivacaine will be administered for both QLB and TAP (0.2 mL per kg on both sides)

QLB; TAP

Paracetamol DRUG

Intravenous paracetamol will be used (1.0 gram), up to 4 grams per day

PCA; QLB; TAP

subarachnoid anesthesia PROCEDURE

subarachnoid anesthesia for each patients participating in the study with pencil point needle

PCA; QLB; TAP

PCA (patient controlled analgesia) PROCEDURE

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)

PCA; QLB; TAP

Metamizol DRUG

Intravenous metamizol will be used (1.0 gram), up to 4 grams per day

PCA; QLB; TAP

Ketoprofen DRUG

Intravenous ketoprofen will be used (0.1 gram), up to 200 milligrams per day

PCA; QLB; TAP

Bupivacaine DRUG

Subarachnoid anesthesia with spinal bupivacaine (MARCAINE SPINAL 0.5% HEAVY)

Also known as: Marcaine

PCA; QLB; TAP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• obtained consent
• singleton pregnancy
• subarachnoid anaesthesia

You may not qualify if:

• coagulopathy
• allergy to morphine and local anesthetics
• depression, antidepressant drugs treatment
• epilepsy
• usage of painkiller before surgery
• addiction to alcohol or recreational drugs

Sponsors & Collaborators

• Medical University of Lublin: lead

Study Sites (2)

Szpital Specjalistyczny PRO-FAMILIA w Rzeszowie

Rzeszów, 35-001, Poland

Location

Szpital Kliniczny Dzieciątka Jezus

Warsaw, 02-005, Poland

Location

Related Publications (3)

• 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.

  PMID: 24249997 BACKGROUND

• 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.

  PMID: 25788791 BACKGROUND

• 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.

  PMID: 33800559 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Neuralgia

Interventions

Ropivacaine; Acetaminophen; Analgesia, Patient-Controlled; Dipyrone; Ketoprofen; Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Acetanilides; Analgesia; Anesthesia and Analgesia; Aminopyrine; Pyrazolones; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants, care providers, and assessors were not aware of type of the block
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Model Details: Participants were randomized 1:1:1

Study Record Dates

• First Submitted: August 4, 2017
• First Posted: August 9, 2017
• Study Start: September 4, 2017
• Primary Completion: October 29, 2018
• Study Completion: August 30, 2019
• Last Updated: February 18, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)