Comparison of the Effects of QLB 2 and QLB 3 on Post-operative Analgesia in Cesarean Section Surgery

NCT04364906 | Completed

• 1 other identifier: QL20011990
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the post-operative analgesic effects of quadratus lomborum block 2 and 3 (QLB 2, 3) in patients having cesarean section with spinal anesthesia. Spinal anesthesia will be performed to all patients for the surgery.

Conditions

Analgesia; Acute Pain; Chronic Pain

Keywords

Regional Anesthesia; Acute and chronical pain; Quadratus Lumborum Blocks; Cesarean Section; Spinal Anesthesia

Outcome Measures

Primary Outcomes (1)

• Opioid consumption in the first 24 hours after surgery

  Morphine consumption in the first 24 hours will be counted by IV patient controlled analgesia device (PCA). Patients will be able to request opioids via PCA device when the nrs score is above 4.

  1 day

Secondary Outcomes (1)

• Post-operative acute pain

  1 day

Study Arms (2)

Quadratus Lumborum Block 2

ACTIVE COMPARATOR

Quadratus Lumborum Block 2 (QLB 2) will be performed the patients in Group A after the cesarean section surgery. Patient controlled analgesia device (PCA) is used for all the patients in the first 24 hours postoperatively

Other: Regional anesthesia

Quadratus Lumborum Block 3

ACTIVE COMPARATOR

Quadratus Lumborum Block 3 (QLB 3) will be performed the patients in Group B after the cesarean section surgery. Patient controlled analgesia device (PCA) is used for all the patients in the first 24 hours postoperatively

Other: Regional anesthesia

Interventions

Regional anesthesia OTHER

The effects of QLB 2, 3 interfascial plane blocks on post-operative analgesia after cesarean section surgery

Also known as: Quadratus Lumborum Block 2, Quadratus Lumborum Block 3

Quadratus Lumborum Block 2; Quadratus Lumborum Block 3

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant women planned for elective cesarean operation
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Being pregnant for at least 37 weeks
• Planning an elective cesarean operation
• Being between the ages of 18-45

You may not qualify if:

• ASA 3-4 patients with comorbitidies (Serious renal, cardiac, hepatic disease)
• Being operated with general anesthesia
• Obesity (\> 100 kg, BMI\> 35 kg / m2)
• Contraindication of regional anesthesia (quagulopathy, abnormal INR, thrombocytopenia, infection at the injection site)
• Hypersensitivity to local anesthetics or a history of allergy
• Patients with a history of opioid use longer than four weeks
• Patients with psychiatric disorders
• Patients with anatomic deformity
• Patients who do not want to participate

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayıs University Faculty of Medicine

Samsun, Other, 55200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia; Acute Pain; Chronic Pain

Interventions

Anesthesia, Conduction

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• ERSİN KÖKSAL, MD

  Ondokuz Mayıs University Faculty of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The anesthesia doctor who will perform the interfascial plane block (QLB 2, 3) will be informed with a sealed envelope by an independent assistant outside the study, and the patient will not know which block is performed.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: Randomization of the study will be done by a doctor who will not participate in patient follow-up with closed envelopes using computer generated randomization codes.

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 28, 2020
• Study Start: April 29, 2020
• Primary Completion: September 15, 2020
• Study Completion: September 15, 2020
• Last Updated: April 19, 2021

Record last verified: 2021-04

Locations

TU (1)