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Bilateral Ultrasound Guided Quadratus Lumborum Versus Lumbar Epidural Block on Postoperative Analgesia, and Inflammatory Response in Abdominal Surgery

Primary Purpose

Postoperative Pain, Inflammatory Response

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Ultrasound quadratus lumborum block with bupivacaine 25%

lumbar epideural block with bupivacaine 25%

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

ASA II, III
Weight 50 - 85 kg.
Scheduled for major lower abdominal cancer surgery (radical cystectomy, total abdominal hysterectomy).

Exclusion Criteria:

Patients with a history of relevant drug allergy.
Coagulation disorders.
Opioid dependence.
Sepsis.
Local infection at the vicinity of the block site.
Patients with psychiatric illnesses that would interfere with perception and assessment of pain

Sites / Locations

South Egypt Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

quadratus lumborum block

lumbar epideural block

Arm Description

received pre-emptive ultrasound-guided quadratus lumborum block with 25 mL of 0.25% bupivacaine on each side of the abdominal wall before induction of GA.

received pre-emptive lumbar epidural block with 15 mL of 0.25% bupivacaine before induction of GA.

Outcomes

Primary Outcome Measures

postoperative pain

postoperative pain intensity.

Secondary Outcome Measures

postoperative inflammatory response

inflammatory response represented by the levels of: interleukins 1,6, and tumor necrosis factor alpha

side effects

sedation, nausea, vomiting, and respiratory depression

Full Information

NCT ID

NCT03958942

First Posted

May 15, 2019

Last Updated

July 2, 2019

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT03958942

Brief Title

Bilateral Ultrasound Guided Quadratus Lumborum Versus Lumbar Epidural Block on Postoperative Analgesia, and Inflammatory Response in Abdominal Surgery

Official Title

Effect of Bilateral Ultrasound Guided Quadratus Lumborum Block Versus Lumbar Epidural Block on Postoperative Analgesia, and Inflammatory Response Following Major Lower Abdominal Cancer Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2019 (Actual)

Primary Completion Date

January 1, 2020 (Anticipated)

Study Completion Date

March 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study aims at comparing the effects of bilateral ultrasound-guided quadratus lumborum block versus lumbar epidural block on postoperative analgesia and inflammatory response following major lower abdominal cancer surgery.

6. Conditions and Keywords

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

Postoperative Pain, Inflammatory Response

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

quadratus lumborum block

Arm Type

Active Comparator

Arm Description

received pre-emptive ultrasound-guided quadratus lumborum block with 25 mL of 0.25% bupivacaine on each side of the abdominal wall before induction of GA.

Arm Title

lumbar epideural block

Arm Type

Active Comparator

Arm Description

received pre-emptive lumbar epidural block with 15 mL of 0.25% bupivacaine before induction of GA.

Intervention Type

Other

Intervention Name(s)

Ultrasound quadratus lumborum block with bupivacaine 25%

Intervention Description

echogenic needle will be inserted in-plane with the ultrasound beam in a posterior-to-anterior direction through the quadratus lumborum muscle until the ventral fascia of the muscle penetrated. At this point, the needle directed toward the fascial plan between the quadratus lumborum and the Psoas muscle

Intervention Type

Other

Intervention Name(s)

lumbar epideural block with bupivacaine 25%

Intervention Description

lumbar epidural will be performed for patients in group II using a 16-gauge Touhy epidural needle by a median approach. The T12 - L1 or L1 - L2 interspaces will be chosen for the injection. The epidural space identified by the loss of resistance technique.

Primary Outcome Measure Information:

Title

postoperative pain

Description

postoperative pain intensity.

Time Frame

first 24 hours postoperatively

Secondary Outcome Measure Information:

Title

postoperative inflammatory response

Description

inflammatory response represented by the levels of: interleukins 1,6, and tumor necrosis factor alpha

Time Frame

first 24 hours postoperatively

Title

side effects

Description

sedation, nausea, vomiting, and respiratory depression

Time Frame

first 24 hours postoperatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ASA II, III Weight 50 - 85 kg. Scheduled for major lower abdominal cancer surgery (radical cystectomy, total abdominal hysterectomy). Exclusion Criteria: Patients with a history of relevant drug allergy. Coagulation disorders. Opioid dependence. Sepsis. Local infection at the vicinity of the block site. Patients with psychiatric illnesses that would interfere with perception and assessment of pain

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ahmad M Abd El-Rahman, M.D.

Phone

00201149606060

ahmad23679@gmail.com

Facility Information:

Facility Name

South Egypt Cancer Institute

City

Assiut

ZIP/Postal Code

171516

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Moaaz El tohamy

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Bilateral Ultrasound Guided Quadratus Lumborum Versus Lumbar Epidural Block on Postoperative Analgesia, and Inflammatory Response in Abdominal Surgery

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