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

Sponsor

Assiut University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03958942

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain Inflammatory Response	Other: Ultrasound quadratus lumborum block with bupivacaine 25% Other: lumbar epideural block with bupivacaine 25%	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 1, 2019

Anticipated Primary Completion Date :

Jan 1, 2020

Anticipated Study Completion Date :

Mar 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: quadratus lumborum block 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.	Other: Ultrasound quadratus lumborum block with bupivacaine 25% 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
Active Comparator: lumbar epideural block received pre-emptive lumbar epidural block with 15 mL of 0.25% bupivacaine before induction of GA.	Other: lumbar epideural block with bupivacaine 25% 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.

Arm

Intervention/Treatment

Active Comparator: quadratus lumborum block

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.

Other: Ultrasound quadratus lumborum block with bupivacaine 25%

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

Active Comparator: lumbar epideural block

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

Other: lumbar epideural block with bupivacaine 25%

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.

Outcome Measures

Primary Outcome Measures

postoperative pain [first 24 hours postoperatively]
postoperative pain intensity.

Secondary Outcome Measures

postoperative inflammatory response [first 24 hours postoperatively]
inflammatory response represented by the levels of: interleukins 1,6, and tumor necrosis factor alpha
side effects [first 24 hours postoperatively]
sedation, nausea, vomiting, and respiratory depression

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	South Egypt Cancer Institute	Assiut		Egypt	171516

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmad Mohammad Abd El-Rahman, assisstant professor of Anesthesia, ICU, and Pain Management, Assiut University

ClinicalTrials.gov Identifier:

NCT03958942

Other Study ID Numbers:

First Posted:

May 22, 2019

Last Update Posted:

Jul 5, 2019

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

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.:

Additional relevant MeSH terms:

Pain, Postoperative

Bupivacaine

Study Results

No Results Posted as of Jul 5, 2019