Tramadol Hydrochnoride as Adjuvant to Local Anesthetic in Ultrasound Guided Erector Spinea Plane Block in Management of Chronic Chest Wall Cancer Pain

NCT04639154 | Unknown

• 1 other identifier: 495
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Chest wall pain is a severe and distressing symptom. The erector spinae plane block (ESPB) is an interfascial plane block where local anesthetic is injected between the erector spine muscle and the transverse process. It is a simple procedure, with easy sonographic landmarks, for postoperative analgesia in patients undergoing thoracic, abdominal, lumbar, and urologic surgery. The ESPB was initially described to relieve chronic pain from metastatic disease and rib fractures.

Conditions

Chronic Pain; Erector Spinea Plane Block

Keywords

chronic chest pain, tramadol hydrochroide, erector spinea plane block

Outcome Measures

Primary Outcomes (1)

• changes in pain intensity measured by visual analog scale (VAS)

  scored from 0 to 10 where 0 = no pain and 10 = the worst pain imaginable

  10 minute after injection, every week for one month after the procedure, 2 month after the procedure

Secondary Outcomes (2)

• a 7-point Likert- like verbal rating scale

  every week for one month after the procedure

• total analgesic requirement

  every week for one month after the procedure, 2 month after the procedure

Study Arms (3)

control group

PLACEBO COMPARATOR

patients will receive a solution of 28 ml of bupivacaine 0.25% and 2 ml of NaCl 0.9% will be added to the local anesthetic solution divided into two levels of injection T5 and T8 in ipsilateral ESPB

Procedure: Erector spinea plane block

tramadol 50

ACTIVE COMPARATOR

patients will receive a solution of 28 ml of bupivacaine 0.25% and 2 ml of tramadol hydrochloride 50 mg will be added to the local anesthetic solution divided into two levels of injection T5 and T8 in ipsilateral ESPB.

Procedure: Erector spinea plane block

tramadol 100

ACTIVE COMPARATOR

patients will receive a solution of 28 ml of bupivacaine 0.25% and 2 ml of tramadol hydrochloride 100 mg will be added to the local anesthetic solution divided into two levels of injection T5 and T8 in ipsilateral ESPB.

Procedure: Erector spinea plane block

Interventions

Erector spinea plane block PROCEDURE

ESPPB will be performed at the T5 and T8 levels of the spine using an in-plane approach. A real-time ultrasound machine will be used to evaluate block performance. A high frequency linear ultrasound probe will be placed longitudinally at a distance of 3 cm from the midline. After identifying the erector spinae muscle and transverse processes, we will insert a 22 G, 100-mm needle after standard skin disinfection. It will be inserted in a caudal-to-cephalad direction using a sterile probe cover until the tip lay in the interfacial plane deep into the erector spinae muscle. This plane will be opened following hydrolocalization with normal saline then 30 mL of 0.25% bupivacaine will be injected slowly, with or without adjuvants, and aspirate every 5 ml to ensure block performance.

control group; tramadol 100; tramadol 50

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with persistent chronic chest wall cancer pain (\>6 months) with VAS pain score ≥ 5 on 0 to 10 scale despite of medical treatment with tramodine up to 200 mg daily

You may not qualify if:

• they have hypersensitivity to any of the studied drugs,
• obesity (BMI \>35),
• presence of local pathology such as recurrent cancer or infection at the site of injection,
• abnormal coagulation profile,
• an abnormal liver or renal function
• unable to express their pain or
• patient refusal

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, 171516, Egypt

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Shereen M Kamal, Associate professor

CONTACT

0100627929; sheridouh79@yahoo.com

Rania M Abdelemam, Lectruer

CONTACT

01006523140

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: November 20, 2020
• Study Start: September 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: March 30, 2022
• Last Updated: August 3, 2021

Record last verified: 2021-07

Locations

EG (1)