Chronic PainNCT04639154
Tramadol Hydrochnoride as Adjuvant to Local Anesthetic in Ultrasound Guided Erector Spinea Plane Block in Management of Chronic Chest Wall Cancer Pain
A study testing Erector spinea plane block in people with Chronic Pain and Erector Spinea Plane Block, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Pain, Erector Spinea Plane Block
- What is being tested?
- Erector spinea plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 30 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Rania M Abdelemam, Lectruer contact
Egypt1 site, 1 recruiting
- Recruiting
Assiut University
Asyut, 171516
Shereen M Kamal, Degree, 01006279209, sheridouh79@yahoo.com
About this study
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
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.
Read the 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
- Being tested
- Erector spinea plane block
- Keywords
- chronic chest pain, tramadol hydrochroide, erector spinea plane block
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinea plane blockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. Receives: Procedure: Erector spinea plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
extremely dissatisfied = 1, dissatisfied=2, somewhat dissatisfied=3, undecided=4, somewhat satisfied=5, satisfied=6, and extremely satisfied=7.
Measured: every week for one month after the procedure
total analgesic requirement
tital amount of analgesia consumed by the patients after the procedure
Measured: every week for one month after the procedure, 2 month after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start1 Sep 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shereen Mamdouh, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04639154
- Sponsor's protocol ID
- 495
- Status last verified
- Jul 2021
- First submitted
- 17 Nov 2020
- Last updated
- 3 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04639154
- Acronym / sponsor ID
- 495
- Conditions
- Chronic Pain, Erector Spinea Plane Block
- Keywords
- chronic chest pain, tramadol hydrochroide, erector spinea plane block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Mar 2022 (estimated)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Procedure: Erector spinea plane blockpatients 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 |
| tramadol 50 | Active comparator | Procedure: Erector spinea plane blockpatients 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. |
| tramadol 100 | Active comparator | Procedure: Erector spinea plane blockpatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erector spinea plane blockESPPB 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. | Procedure or surgery | control group, tramadol 100, tramadol 50 |
Primary outcome
changes in pain intensity measured by visual analog scale (VAS)
Time frame: 10 minute after injection, every week for one month after the procedure, 2 month after the procedure
scored from 0 to 10 where 0 = no pain and 10 = the worst pain imaginable
2 secondary outcomes
a 7-point Likert- like verbal rating scale
Time frame: every week for one month after the procedure
total analgesic requirement
Time frame: every week for one month after the procedure, 2 month after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rania M Abdelemam, Lectruer contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector spinea plane block in people with Chronic Pain and Erector Spinea Plane Block, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shereen M Kamal, Associate professor (0100627929, sheridouh79@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in pain intensity measured by visual analog scale (VAS) (time frame: 10 minute after injection, every week for one month after the procedure, 2 month after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021; AzTrials last refreshed its copy on 8 Nov 2026.