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

Comparison of the Effects of Quadratus Lumborum Block 2 and 3 (QLB 2 and QLB 3) on Post-operative Analgesia in Cesarean Section Surgery

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Analgesia; Acute Pain
• Intervention / Treatment: Other: Regional anesthesia

Detailed Description

In this study, patients are divided into two groups. After the spinal anesthesia is performed and cesarean section surgery is over; QLB 2 block will be performed to patients in Group A ; while QLB 3 block will be performed to patients in Group B.

In addition, patient controlled analgesia (PCA) will be used in the first 24 hours postoperatively.

Group A - Patients in group A will have QLB 2 block after the surgery. In addition, patient controlled analgesia (PCA) will be used in the first 24 hours postoperatively.

Group B - Patients in group B will have QLB 3 block after the surgery. In addition, patient controlled analgesia (PCA) will be used in the first 24 hours postoperatively.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Other
    • Samsun, Other, Turkey, 55200
      • Ondokuz Mayıs University Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Quadratus Lumborum Block 2; 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; The effects of QLB 2, 3 interfascial plane blocks on post-operative analgesia after cesarean section surgery; Other Names: Quadratus Lumborum Block 2; Quadratus Lumborum Block 3
Active Comparator: Quadratus Lumborum Block 3; 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; The effects of QLB 2, 3 interfascial plane blocks on post-operative analgesia after cesarean section surgery; Other Names: Quadratus Lumborum Block 2; Quadratus Lumborum Block 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative acute pain	Pain status will be evaluated based on NRS scores. Pain status will be evaluated at 1, 3, 6, 9, 12, 18, 24. hours after surgery. Each NRS is scores 0-10. (0=no pain ; 10=pain as bad as can be)	1 day

Collaborators and Investigators

• Sponsor: Ondokuz Mayıs University
• Investigators: Study Director: ERSİN KÖKSAL, MD, Ondokuz Mayıs University Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2020
• Primary Completion (Actual): September 15, 2020
• Study Completion (Actual): September 15, 2020

Study Registration Dates

• First Submitted: April 23, 2020
• First Submitted That Met QC Criteria: April 23, 2020
• First Posted (Actual): April 28, 2020

Study Record Updates

• Last Update Posted (Actual): April 19, 2021
• Last Update Submitted That Met QC Criteria: April 15, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Regional Anesthesia; Cesarean Section; Spinal Anesthesia; Acute and chronical pain; Quadratus Lumborum Blocks
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: QL20011990

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No