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

Primary Purpose

Chronic Pain, Erector Spinea Plane Block

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Erector spinea plane block
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring chronic chest pain, tramadol hydrochroide, erector spinea plane block

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Assiut UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

control group

tramadol 50

tramadol 100

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
total analgesic requirement
tital amount of analgesia consumed by the patients after the procedure

Full Information

First Posted
November 17, 2020
Last Updated
July 28, 2021
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04639154
Brief Title
Tramadol Hydrochnoride as Adjuvant to Local Anesthetic in Ultrasound Guided Erector Spinea Plane Block in Management of Chronic Chest Wall Cancer Pain
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
March 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Erector Spinea Plane Block
Keywords
chronic chest pain, tramadol hydrochroide, erector spinea plane block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
tramadol 50
Arm Type
Active Comparator
Arm Description
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.
Arm Title
tramadol 100
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Erector spinea plane block
Intervention Description
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.
Primary Outcome Measure Information:
Title
changes in pain intensity measured by visual analog scale (VAS)
Description
scored from 0 to 10 where 0 = no pain and 10 = the worst pain imaginable
Time Frame
10 minute after injection, every week for one month after the procedure, 2 month after the procedure
Secondary Outcome Measure Information:
Title
a 7-point Likert- like verbal rating scale
Description
extremely dissatisfied = 1, dissatisfied=2, somewhat dissatisfied=3, undecided=4, somewhat satisfied=5, satisfied=6, and extremely satisfied=7.
Time Frame
every week for one month after the procedure
Title
total analgesic requirement
Description
tital amount of analgesia consumed by the patients after the procedure
Time Frame
every week for one month after the procedure, 2 month after the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shereen M Kamal, Associate professor
Phone
0100627929
Email
sheridouh79@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rania M Abdelemam, Lectruer
Phone
01006523140
Facility Information:
Facility Name
Assiut University
City
Assiut
ZIP/Postal Code
171516
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shereen M Kamal, Degree
Phone
01006279209
Email
sheridouh79@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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