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

Effect of Tramadol Hydrochnoride as Adjuvant to Local Anesthetic in Ultrasound Guided Erector Spinea Plane Block in Management of Chronic Chest Wall Cancer Pain: a Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Erector Spinea Plane Block
• Intervention / Treatment: Procedure: Erector spinea plane block

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

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shereen M Kamal, Associate professor; Phone Number: 0100627929; Email: sheridouh79@yahoo.com
• Study Contact Backup: Name: Rania M Abdelemam, Lectruer; Phone Number: 01006523140

Study Locations

• Egypt
  • Assiut, Egypt, 171516
    • Recruiting
    • Assiut University
    • Contact: Shereen M Kamal, Degree; Phone Number: 01006279209; Email: sheridouh79@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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	Procedure: 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.
Active Comparator: 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.	Procedure: 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.
Active Comparator: 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
a 7-point Likert- like verbal rating scale	extremely dissatisfied = 1, dissatisfied=2, somewhat dissatisfied=3, undecided=4, somewhat satisfied=5, satisfied=6, and extremely satisfied=7.	every week for one month after the procedure
total analgesic requirement	tital amount of analgesia consumed by the patients after the procedure	every week for one month after the procedure, 2 month after the procedure

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): March 30, 2022

Study Registration Dates

• First Submitted: November 17, 2020
• First Submitted That Met QC Criteria: November 19, 2020
• First Posted (Actual): November 20, 2020

Study Record Updates

• Last Update Posted (Actual): August 3, 2021
• Last Update Submitted That Met QC Criteria: July 28, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: chronic chest pain, tramadol hydrochroide, erector spinea plane block
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Cancer Pain
• Other Study ID Numbers: 495

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No