Regional Analgesia After Cesarean Section

Efficacy of Regional Analgesia Techniques (Quadratus Lumborum Block and Transversus Abdominis Plane Block) in Acute and Chronic Pain Treatment in Patients After Cesarean Delivery

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).

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Cesarean Section; Pain, Neuropathic
• Intervention / Treatment: Drug: Ketoprofen; Drug: Paracetamol; Drug: Metamizol; Procedure: subarachnoid anesthesia; Procedure: PCA (patient controlled analgesia); Drug: Bupivacaine; Procedure: TAP (transversus abdominis plane block); Device: Stimuplex Ultra 360 needle; Drug: Ropivacaine; Procedure: QLB (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.

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.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Phase 4

Contacts and Locations

Study Locations

• Poland
  • Rzeszów, Poland, 35-001
    • Szpital Specjalistyczny PRO-FAMILIA w Rzeszowie
  • Warszawa, Poland, 02-005
    • Szpital Kliniczny Dzieciatka Jezus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PCA; Subarchnoid anesthesia with bupivacaine PCA with morphine in the PACU	Drug: Ketoprofen; Intravenous ketoprofen will be used (0.1 gram), up to 200 milligrams per day; 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: subarachnoid anesthesia; subarachnoid anesthesia for each patients participating in the study with pencil point needle; Procedure: PCA (patient controlled analgesia); 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); Drug: Bupivacaine; Subarachnoid anesthesia with spinal bupivacaine (MARCAINE SPINAL 0.5% HEAVY); Other Names: Marcaine
EXPERIMENTAL: TAP; 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	Drug: Ketoprofen; Intravenous ketoprofen will be used (0.1 gram), up to 200 milligrams per day; 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: subarachnoid anesthesia; subarachnoid anesthesia for each patients participating in the study with pencil point needle; Procedure: PCA (patient controlled analgesia); 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); Drug: Bupivacaine; Subarachnoid anesthesia with spinal bupivacaine (MARCAINE SPINAL 0.5% HEAVY); Other Names: Marcaine; Procedure: TAP (transversus abdominis plane block); ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain; Device: Stimuplex Ultra 360 needle; ultrasound-guided needle will be used for QLB and TAP and regional blocks; Drug: Ropivacaine; 0.375 % ropivacaine will be administered for both QLB and TAP (0.2 mL per kg on both sides)
EXPERIMENTAL: QLB; 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	Drug: Ketoprofen; Intravenous ketoprofen will be used (0.1 gram), up to 200 milligrams per day; 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: subarachnoid anesthesia; subarachnoid anesthesia for each patients participating in the study with pencil point needle; Procedure: PCA (patient controlled analgesia); 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); Drug: Bupivacaine; Subarachnoid anesthesia with spinal bupivacaine (MARCAINE SPINAL 0.5% HEAVY); Other Names: Marcaine; Device: Stimuplex Ultra 360 needle; ultrasound-guided needle will be used for QLB and TAP and regional blocks; Drug: Ropivacaine; 0.375 % ropivacaine will be administered for both QLB and TAP (0.2 mL per kg on both sides); Procedure: QLB (quadratus lumborum block); ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain

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
Morphine consumption	Total morphine consumption	up to 24 hours after surgery

Collaborators and Investigators

• Sponsor: Medical 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 4, 2017
• Primary Completion (ACTUAL): October 29, 2018
• Study Completion (ACTUAL): August 30, 2019

Study Registration Dates

• First Submitted: August 4, 2017
• First Submitted That Met QC Criteria: August 8, 2017
• First Posted (ACTUAL): August 9, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 18, 2020
• Last Update Submitted That Met QC Criteria: February 16, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: transversus abdominis plane block; neuropathic pain; postoperative pain; quadratus lumborum block
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pain, Postoperative; 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; Anesthetics, Local; Acetaminophen; Bupivacaine; Ropivacaine; Ketoprofen; Dipyrone
• Other Study ID Numbers: KE-0254/127/2017

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