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

NCT ID: NCT04639154

Last Updated: 2021-08-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2022-03-30

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.

Detailed Description

Chest wall pain is a severe and distressing symptom.Interventional pain management aims to use invasive techniques such as joint injections, nerve blocks and/or neurolysis, neuromodulation, and cement augmentation techniques to diagnose and treat pain syndromes unresponsive to conventional medical management. The erector spinae plane block (ESPB) is an interfascial plane block where local anesthetic (LA) 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.

The ESPB provides blockade of ventral and dorsal ramus from T1-2 to T8-12 with easy insertion of a catheter into the distension induced by the injectate. It is performed away from the pleura and neuraxis, with low risk of complications in these structures.To our knowledge it is the first time study to evaluate the effectiveness of tramadol hydrochloride as adjuvant to local anaesthetic in ultrasound guided ESPB in the management of chronic chest wall cancer pain. Our hypothesis is that tramadol, when added to the local anaesthetic solution injected for ESPB, may improve analgesia and decrease the opioid consumption in patients with chronic chest wall cancer pain

Conditions

Chronic Pain; Erector Spinea Plane Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

control group

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

Group Type: PLACEBO_COMPARATOR

Erector spinea plane block

Intervention Type: 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.

tramadol 50

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.

Group Type: ACTIVE_COMPARATOR

Erector spinea plane block

Intervention Type: 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.

tramadol 100

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.

Group Type: ACTIVE_COMPARATOR

Erector spinea plane block

Intervention Type: 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.

Interventions

Erector spinea plane block

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Shereen Mamdouh

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut University

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Shereen M Kamal, Associate professor

Role: CONTACT

sheridouh79@yahoo.com

0100627929

Rania M Abdelemam, Lectruer

Role: CONTACT

01006523140

Facility Contacts

Shereen M Kamal, Degree

Role: primary

sheridouh79@yahoo.com

01006279209

Other Identifiers

495

Identifier Type: -

Identifier Source: org_study_id