Comparison Between Retrolaminar Block Combined With Erector Spinae Plane Block, and Erector Spinae Plane Block Alone for Post-thoracotomy Pain

NCT05791539 | Unknown

• 1 other identifier: MS-397-2022
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Post-thoracotomy pain is a challenging clinical problem that may be associated with increased morbidity and mortality. The current study tests two techniques of regional anaesthesia to control post thoracotomy pain

Conditions

Post-thoracotomy Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• Total amount of morphine consumption in the first 24-hour postoperative in the two groups.

  20ml for ESPB compared to 10ml ESPB added to 10ml RLB.

  24 hours

Secondary Outcomes (5)

• •Pain score according to VAS score

  24 hours

• • Heart rate

  intraoperative

• Incidence of complications

  24 hours

• .First request of analgesia postoperative

  24 hours

• MAP

  intraoperative

Study Arms (3)

Group 1 Erector spinae plane block

EXPERIMENTAL

Group 1 (ESPB (control group): (n = 15) patients will receive preoperative US-guided ESPB on the operated side by 20 ml bupivacaine 0.25%.

Procedure: Erector spinae plane block

Group 2: Erector spinae plane block

EXPERIMENTAL

US-guided ESPB with 10 ml bupivacaine 0.25% (n = 15) on the operated side.

Procedure: Erector spinae plane block

Retro laminar block

EXPERIMENTAL

the US-guided retrolaminar block 10 ml bupivacaine 0.25% group: (n = 15) on the operated side.

Procedure: erector spinae plane block + retrolaminar block

Interventions

Erector spinae plane block PROCEDURE

Patients will be divided into 2 groups group 1 will receive US-guided ESPB and group 2 will receive US-guided ESPB + US-guided Retrolaminar plain block before induction of GA.

Group 1 Erector spinae plane block; Group 2: Erector spinae plane block

erector spinae plane block + retrolaminar block PROCEDURE

Patients will be divided into 2 groups group 1 will receive US-guided ESPB and group 2 will receive US-guided ESPB + US-guided Retrolaminar plain block before induction of GA.

Retro laminar block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 18-65 years.
• body mass index (BMI) ranged between 20 and 40 kg/m2

You may not qualify if:

• Patient refusal.
• Sensitivity or contraindication to local anesthetic drugs.
• History of psychological disorders and/or chronic pain.
• Localized infection at the site of the block.
• Coagulopathies, patients on anticoagulants and antiplatelets, and significant liver or renal insufficiency

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo Unviersity

Cairo, Egypt

RECRUITING

Study Officials

• sherif mamdouh, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

sherif mamdouh, MD

CONTACT

01141235049; s25041989@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomization will be accomplished through the use of computer-generated random numbers and closed opaque envelopes. Another anesthesiologist who will not be involved in the other parts of the study will open the envelopes to enroll patients. and both patients and outcome assessors will be blinded to the assignment of groups.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: March 30, 2023
• Study Start: February 2, 2023
• Primary Completion: October 12, 2023
• Study Completion: November 1, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-08

Locations

EG (1)