Back to results

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

Primary Purpose

Analgesia, Acute Pain, Chronic Pain

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Regional anesthesia

About this trial

This is an interventional supportive care trial for Analgesia focused on measuring Regional Anesthesia, Acute and chronical pain, Quadratus Lumborum Blocks, Cesarean Section, Spinal Anesthesia

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Ondokuz Mayıs University Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Quadratus Lumborum Block 2

Quadratus Lumborum Block 3

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

Full Information

NCT ID

NCT04364906

First Posted

April 23, 2020

Last Updated

April 15, 2021

Sponsor

Ondokuz Mayıs University

1. Study Identification

Unique Protocol Identification Number

NCT04364906

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

April 29, 2020 (Actual)

Primary Completion Date

September 15, 2020 (Actual)

Study Completion Date

September 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ondokuz Mayıs University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Analgesia, Acute Pain, Chronic Pain

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Quadratus Lumborum Block 2

Arm Type

Active Comparator

Arm Description

Arm Title

Quadratus Lumborum Block 3

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Regional anesthesia

Other Intervention Name(s)

Quadratus Lumborum Block 2, Quadratus Lumborum Block 3

Intervention Description

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

Primary Outcome Measure Information:

Title

Opioid consumption in the first 24 hours after surgery

Description

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.

Time Frame

1 day

Secondary Outcome Measure Information:

Title

Post-operative acute pain

Description

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)

Time Frame

1 day

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Pregnant women planned for elective cesarean operation

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ERSİN KÖKSAL, MD

Organizational Affiliation

Ondokuz Mayıs University Faculty of Medicine

Official's Role

Study Director

Facility Information:

Facility Name

Ondokuz Mayıs University Faculty of Medicine

City

Samsun

State/Province

Other

ZIP/Postal Code

55200

Country

Turkey

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs