Chronic Postoperative PainNCT06036979
Preoperative Erector Spinae Plane Block Versus Paravertebral Plane Block in Decreasing Post Mastectomy Pain Syndrome
A study testing Paravertebral plane block, Erector spinae plane block and Intravenous morphine, ketorlac and paracetamol in people with Chronic Postoperative Pain, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
Breast cancer is considered the commonest malignancy affecting women with an incidence exceeding one million cases per year. Although it has a favorable prognosis with improved lines of treatment, some complications may still disturb the patient's life quality. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Postoperative Pain
- What is being tested?
- Paravertebral plane block, Erector spinae plane block and Intravenous morphine, ketorlac and paracetamol
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to 1 Feb 2025
- 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age ≥ 18 years and ≤ 60 years old.
- Female patients ASA ΙΙ, ΙΙΙ.
- Female patients scheduled for unilateral breast surgeries.
Who cannot join
- Patient refusal.
- Patients have sepsis
- Patients known to have allergy against local anesthetics.
- Patients with prior surgery in areas above or below the clavicle or in the axillary region.
- Patients with opioid dependence, alcohol or drug abuse.
- Patient with coagulopathy.
- Patients with psychiatric illness that prevent them from proper pain perception and assessment.
- ASA 4 or higher.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study Between Preoperative Erector Spinae Plane Block Versus Preoperative Paravertebral Plane Block in Decreasing Post Mastectomy Pain Syndrome. A Randomized Controlled Study.
Breast cancer is considered the commonest malignancy affecting women with an incidence exceeding one million cases per year. Although it has a favorable prognosis with improved lines of treatment, some complications may still disturb the patient's life quality. One of these complications is post-mastectomy pain syndrome (PMPS) .Regional Anaesthesia (RA) is considered one of the most effective methods in reducing acute pain after breast surgeries, these include pectoral nerves block (PECS), serratus anterior plane block (SAPB), paravertebral plane block (PVPB) and erector spinae plane block (ESPB) . Our study is aiming for comparing the effect of preoperative PVPB versus preoperative ESPB in the prevention of PMPS in patients undergoing unilateral breast surgeries.
Read the detailed description
Breast cancer is considered the commonest malignancy affecting women with an incidence exceeding one million cases per year. Although it has a favorable prognosis with improved lines of treatment, some complications may still disturb the patient's life quality. One of these complications is post-mastectomy pain syndrome (PMPS) ¹.
The International Association for Study of Pain (IASP) defines PMPS as chronic pain that persists more than 3 months in the anterior thorax, axilla \&/or upper arm ². It is usually neuropathic in nature includes altered sensations such as dysesthesia, hypo or hyperesthesia, allodynia or particular qualities of dysesthesia e.g burning, dull aching sensations. It is usually of at least moderate intensity and may be either continuous or intermittent pain ³.
The etiology and mechanism of PMPS remain incompletely clear yet. Some risk factors are believed to be associated with PMPS, including the presence and intensity of postoperative pain, the type of surgery, younger women, prior history of other types of pain and adjuvant therapies like chemo or radiotherapy ⁴.
Regional Anaesthesia (RA) is considered one of the most effective methods in reducing acute pain after breast surgeries, these include pectoral nerves block (PECS), serratus anterior plane block (SAPB), paravertebral plane block (PVPB) and erector spinae plane block (ESPB) ⁵. Theoretically RA can minimize the development of PMPS by decreasing the afferent nociceptive input and central sensitization during the perioperative period, However clinically the role of RA in preventing PMPS is still under investigations ⁶.
PVPB includes injecting local anesthetic in the paravertebral space where the spinal nerves exit from the intervertebral foraminae. Paravertebral space is bounded by the parietal pleura, superior costotransverse ligament, vertebrae, intervertebral foraminae and the heads of the ribs ⁷. While ESPB includes injection of the local anesthetic in the fascial plane between the vertebral transverse processes and the erector spinae muscle ⁸.
Many studies were done in order to evaluate the efficacy of either ESPB or PVB in controlling acute postoperative pain after breast surgeries, some studies compared between them in controlling acute postoperative pain after breast surgeries ⁹. Also there are some studies that evaluate the effect of either ESPB or PVPB in the prevention of PMPS after breast surgeries ¹⁰, but still the comparison between the effect of preoperative ESPB versus the effect of preoperative PVPB in the prevention of PMPS in patients undergoing breast surgeries is still under investigated.
Our study is aiming for comparing the effect of preoperative PVPB versus preoperative ESPB in the prevention of PMPS in patients undergoing unilateral breast surgeries.
- Conditions
- Chronic Postoperative Pain
- Being tested
- Paravertebral plane block, Erector spinae plane block, Intravenous morphine, ketorlac and paracetamol
- Keywords
- PVPB, ESPB, prevention of PMPS
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paravertebral plane blockProcedure or surgery
Also called PVPB
With the patients are placed in the sitting position, counting down from C7 spinous process, a high frequency linear ultrasound probe is placed on the spinous process in the parasagittal plane at T5 level and then is slided laterally 2-3 cm to make the transverse processes clearly visualized . Under aseptic conditions, a 22-gauge block needle (50mm, B.Braun, Germany) is inserted using in-plane technique toward the paravertebral space, immediately above the pleura and below the superior costotransverse ligament. The position of the needle is confirmed by the descent of the pleura when injecting 2 to 3 ml of saline solution for hydrolocalization. Then 0.3ml/kg of bupivacaine 0.25% is injected under ultrasound guidance. Block success is defined as reduced sensitivity to cold and pinprick stimuli as compared with the contralateral side 20 minutes after local anesthetic injection.
Erector spinae plane blockProcedure or surgery
Also called ESPB
With the patients are placed in the sitting position, counting down from C7 spinous process, a high frequency linear ultrasound probe is placed on the spinous process in the parasagittal plane at T5 level and then is slided laterally 2-3 cm to make the tips of the transverse processes clearly visualized . The following muscles seen from superficial to deep layer are trapezius, rhomboid major and erector spinae muscles. Under aseptic conditions, a 22-gauge block needle (50mm, B.Braun, Germany) is inserted using in-plane technique to reach the interfascial plane between the transverse process and the erector spinae muscle. Following confirmation of the accurate position of the needle tip with 3-5 ml normal saline solution, 0.3ml/kg of bupivacaine 0.25% is injected under ultrasound guidance. Block success is defined as reduced sensitivity to cold and pinprick stimuli as compared with the contralateral side 20 minutes after local anesthetic injection.
Intravenous morphine, ketorlac and paracetamolDrug
Also called IV analgesics
- In the control group only we add 10mg intravenous morphine, 30 mg intravenous ketorlac and 1 gm intravenous paracetamol for analgesia.
| Study group | Role | What they receive |
|---|---|---|
| Paravertebral Block Group | Active comparator | This group will receive combined general anaesthesia with preoperative ultrasound guide paravertebral plane block Receives: Procedure: Paravertebral plane block |
| Erector Spinae Block Group | Active comparator | This group will receive combined general anaesthesia with preoperative ultrasound guided erector spinae plane block Receives: Procedure: Erector spinae plane block |
| Control Group | Other | This group will receive balanced general anesthesia using intravenous (0.1mg/kg) morphine, 30 mg ketorlac and 1 gm paracetamol). Receives: Drug: Intravenous morphine, ketorlac and paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is to assess the incidence of PMPS 3 months after surgery.
- A junior pain physician is blinded to all treatment groups and asks about symptoms of PMPS including (pain, tingling, numbness, shooting pain, pricking pain or unbearable itching), site (chest wall, armpit, arm, shoulder or surgical scar) and grading scale using the brief pain inventory (BPI).
- Chronic pain is defined by a score of ≥ 3 on the single item (average pain) of the BPI.
- The BPI consists of three domains: (1) Pain intensity measured using the visual analogue scale (VAS) of 0 (no pain) to 10 (worst pain). (2) Pain that interferes with daily activities measured using a scale of 0 (no interference) to 10 (complete restriction to daily activities). (3) Percentage of relief provided by pain treatments measured using a scale of 0 (complete relief) to 10 (no relief) by the NRS.
Measured: 3 months
Secondary outcomes (4)
• The prevalence of PMPS at 6 months.
- The prevalence of PMPS at 6 months.
Measured: 6 months
• Assessment of acute postoperative pain.
- Assessment of acute postoperative pain using VAS (0 for no pain, 10 for the worst pain) at 0, 4, 8, 24 and 48 hours postoperatively.
Measured: 48 hours
• Time to first needed morphine dose postoperatively, total 24-48 hours morphine consumption.
- Time to first needed morphine dose postoperatively, total 24-48 hours morphine consumption.
Measured: 48 hours .
• PVPB and ESPB related complications.
- PVPB and ESPB related complications (bupivacaine toxicity, pneumothorax).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start1 Jul 2024 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Chronic Postoperative PainStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suzan Ahmed, MS degree, Principal investigator, National Cancer Institute, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036979
- Sponsor's protocol ID
- AP2303-301-0007
- Status last verified
- Jun 2024
- First submitted
- 7 Sep 2023
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol will be shared
Publications
Harkouk H, Fletcher D, Martinez V. Paravertebral block for the prevention of chronic postsurgical pain after breast cancer surgery. Reg Anesth Pain Med. 2021 Mar;46(3):251-257. doi: 10.1136/rapm-2020-102040. Epub 2021 Jan 7.
PubMed 33414157Yuksel SS, Chappell AG, Jackson BT, Wescott AB, Ellis MF. "Post Mastectomy Pain Syndrome: A Systematic Review of Prevention Modalities". JPRAS Open. 2021 Oct 30;31:32-49. doi: 10.1016/j.jpra.2021.10.009. eCollection 2022 Mar.
PubMed 34926777Waltho D, Rockwell G. Post-breast surgery pain syndrome: establishing a consensus for the definition of post-mastectomy pain syndrome to provide a standardized clinical and research approach - a review of the literature and discussion. Can J Surg. 2016 Sep;59(5):342-50. doi: 10.1503/cjs.000716.
PubMed 27668333Gong Y, Tan Q, Qin Q, Wei C. Prevalence of postmastectomy pain syndrome and associated risk factors: A large single-institution cohort study. Medicine (Baltimore). 2020 May;99(20):e19834. doi: 10.1097/MD.0000000000019834.
PubMed 32443289Xin L, Hou N, Zhang Z, Feng Y. The Effect of Preoperative Ultrasound-Guided Erector Spinae Plane Block on Chronic Postsurgical Pain After Breast Cancer Surgery: A Propensity Score-Matched Cohort Study. Pain Ther. 2022 Mar;11(1):93-106. doi: 10.1007/s40122-021-00339-9. Epub 2021 Nov 26.
PubMed 34826113Zinboonyahgoon N, Patton ME, Chen YK, Edwards RR, Schreiber KL. Persistent Post-Mastectomy Pain: The Impact of Regional Anesthesia Among Patients with High vs Low Baseline Catastrophizing. Pain Med. 2021 Aug 6;22(8):1767-1775. doi: 10.1093/pm/pnab039.
PubMed 33560352Batra RK, Krishnan K, Agarwal A. Paravertebral block. J Anaesthesiol Clin Pharmacol. 2011 Jan;27(1):5-11. No abstract available.
PubMed 21804697Bonvicini D, Boscolo-Berto R, De Cassai A, Negrello M, Macchi V, Tiberio I, Boscolo A, De Caro R, Porzionato A. Anatomical basis of erector spinae plane block: a dissection and histotopographic pilot study. J Anesth. 2021 Feb;35(1):102-111. doi: 10.1007/s00540-020-02881-w. Epub 2020 Dec 19.
PubMed 33340344El Ghamry MR, Amer AF. Role of erector spinae plane block versus paravertebral block in pain control after modified radical mastectomy. A prospective randomised trial. Indian J Anaesth. 2019 Dec;63(12):1008-1014. doi: 10.4103/ija.IJA_310_19. Epub 2019 Dec 11.
PubMed 31879425
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Preoperative Erector Spinae Plane Block Versus Preoperative Paravertebral Plane Block in Decreasing Post Mastectomy Pain Syndrome. A Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT06036979
- Acronym / sponsor ID
- AP2303-301-0007
- Conditions
- Chronic Postoperative Pain
- Keywords
- PVPB, ESPB, prevention of PMPS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 14 Sep 2023 (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.
Breast cancer is considered the commonest malignancy affecting women with an incidence exceeding one million cases per year. Although it has a favorable prognosis with improved lines of treatment, some complications may still disturb the patient's life quality. One of these complications is post-mastectomy pain syndrome (PMPS) .Regional Anaesthesia (RA) is considered one of the most effective methods in reducing acute pain after breast surgeries, these include pectoral nerves block (PECS), serratus anterior plane block (SAPB), paravertebral plane block (PVPB) and erector spinae plane block (ESPB) . Our study is aiming for comparing the effect of preoperative PVPB versus preoperative ESPB in the prevention of PMPS in patients undergoing unilateral breast surgeries.
Detailed description
Breast cancer is considered the commonest malignancy affecting women with an incidence exceeding one million cases per year. Although it has a favorable prognosis with improved lines of treatment, some complications may still disturb the patient's life quality. One of these complications is post-mastectomy pain syndrome (PMPS) ¹.
The International Association for Study of Pain (IASP) defines PMPS as chronic pain that persists more than 3 months in the anterior thorax, axilla \&/or upper arm ². It is usually neuropathic in nature includes altered sensations such as dysesthesia, hypo or hyperesthesia, allodynia or particular qualities of dysesthesia e.g burning, dull aching sensations. It is usually of at least moderate intensity and may be either continuous or intermittent pain ³.
The etiology and mechanism of PMPS remain incompletely clear yet. Some risk factors are believed to be associated with PMPS, including the presence and intensity of postoperative pain, the type of surgery, younger women, prior history of other types of pain and adjuvant therapies like chemo or radiotherapy ⁴.
Regional Anaesthesia (RA) is considered one of the most effective methods in reducing acute pain after breast surgeries, these include pectoral nerves block (PECS), serratus anterior plane block (SAPB), paravertebral plane block (PVPB) and erector spinae plane block (ESPB) ⁵. Theoretically RA can minimize the development of PMPS by decreasing the afferent nociceptive input and central sensitization during the perioperative period, However clinically the role of RA in preventing PMPS is still under investigations ⁶.
PVPB includes injecting local anesthetic in the paravertebral space where the spinal nerves exit from the intervertebral foraminae. Paravertebral space is bounded by the parietal pleura, superior costotransverse ligament, vertebrae, intervertebral foraminae and the heads of the ribs ⁷. While ESPB includes injection of the local anesthetic in the fascial plane between the vertebral transverse processes and the erector spinae muscle ⁸.
Many studies were done in order to evaluate the efficacy of either ESPB or PVB in controlling acute postoperative pain after breast surgeries, some studies compared between them in controlling acute postoperative pain after breast surgeries ⁹. Also there are some studies that evaluate the effect of either ESPB or PVPB in the prevention of PMPS after breast surgeries ¹⁰, but still the comparison between the effect of preoperative ESPB versus the effect of preoperative PVPB in the prevention of PMPS in patients undergoing breast surgeries is still under investigated.
Our study is aiming for comparing the effect of preoperative PVPB versus preoperative ESPB in the prevention of PMPS in patients undergoing unilateral breast surgeries.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Paravertebral Block Group | Active comparator | Procedure: Paravertebral plane blockThis group will receive combined general anaesthesia with preoperative ultrasound guide paravertebral plane block |
| Erector Spinae Block Group | Active comparator | Procedure: Erector spinae plane blockThis group will receive combined general anaesthesia with preoperative ultrasound guided erector spinae plane block |
| Control Group | Other | Drug: Intravenous morphine, ketorlac and paracetamolThis group will receive balanced general anesthesia using intravenous (0.1mg/kg) morphine, 30 mg ketorlac and 1 gm paracetamol). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years and ≤ 60 years old.
- Female patients ASA ΙΙ, ΙΙΙ.
- Female patients scheduled for unilateral breast surgeries.
Key exclusion criteria (8 listed)
- Patient refusal.
- Patients have sepsis
- Patients known to have allergy against local anesthetics.
- Patients with prior surgery in areas above or below the clavicle or in the axillary region.
- Patients with opioid dependence, alcohol or drug abuse.
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 |
|---|---|---|
| Paravertebral plane blockAlso: PVPBWith the patients are placed in the sitting position, counting down from C7 spinous process, a high frequency linear ultrasound probe is placed on the spinous process in the parasagittal plane at T5 level and then is slided laterally 2-3 cm to make the transverse processes clearly visualized . Under aseptic conditions, a 22-gauge block needle (50mm, B.Braun, Germany) is inserted using in-plane technique toward the paravertebral space, immediately above the pleura and below the superior costotransverse ligament. The position of the needle is confirmed by the descent of the pleura when injecting 2 to 3 ml of saline solution for hydrolocalization. Then 0.3ml/kg of bupivacaine 0.25% is injected under ultrasound guidance. Block success is defined as reduced sensitivity to cold and pinprick stimuli as compared with the contralateral side 20 minutes after local anesthetic injection. | Procedure or surgery | Paravertebral Block Group |
| Erector spinae plane blockAlso: ESPBWith the patients are placed in the sitting position, counting down from C7 spinous process, a high frequency linear ultrasound probe is placed on the spinous process in the parasagittal plane at T5 level and then is slided laterally 2-3 cm to make the tips of the transverse processes clearly visualized . The following muscles seen from superficial to deep layer are trapezius, rhomboid major and erector spinae muscles. Under aseptic conditions, a 22-gauge block needle (50mm, B.Braun, Germany) is inserted using in-plane technique to reach the interfascial plane between the transverse process and the erector spinae muscle. Following confirmation of the accurate position of the needle tip with 3-5 ml normal saline solution, 0.3ml/kg of bupivacaine 0.25% is injected under ultrasound guidance. Block success is defined as reduced sensitivity to cold and pinprick stimuli as compared with the contralateral side 20 minutes after local anesthetic injection. | Procedure or surgery | Erector Spinae Block Group |
| Intravenous morphine, ketorlac and paracetamolAlso: IV analgesics• In the control group only we add 10mg intravenous morphine, 30 mg intravenous ketorlac and 1 gm intravenous paracetamol for analgesia. | Drug | Control Group |
Primary outcome
The primary outcome is to assess the incidence of PMPS 3 months after surgery.
Time frame: 3 months
* A junior pain physician is blinded to all treatment groups and asks about symptoms of PMPS including (pain, tingling, numbness, shooting pain, pricking pain or unbearable itching), site (chest wall, armpit, arm, shoulder or surgical scar) and grading scale using the brief pain inventory (BPI). * Chronic pain is defined by a score of ≥ 3 on the single item (average pain) of the BPI. * The BPI consists of three domains: (1) Pain intensity measured using the visual analogue scale (VAS) of 0 (no pain) to 10 (worst pain). (2) Pain that interferes with daily activities measured using a scale of 0 (no interference) to 10 (complete restriction to daily activities). (3) Percentage of relief provided by pain treatments measured using a scale of 0 (complete relief) to 10 (no relief) by the NRS.
4 secondary outcomes
• The prevalence of PMPS at 6 months.
Time frame: 6 months
• Assessment of acute postoperative pain.
Time frame: 48 hours
• Time to first needed morphine dose postoperatively, total 24-48 hours morphine consumption.
Time frame: 48 hours .
• PVPB and ESPB related complications.
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Background: PubMed 33414157Harkouk H, Fletcher D, Martinez V. Paravertebral block for the prevention of chronic postsurgical pain after breast cancer surgery. Reg Anesth Pain Med. 2021 Mar;46(3):251-257. doi: 10.1136/rapm-2020-102040. Epub 2021 Jan 7.
- Background: PubMed 34926777Yuksel SS, Chappell AG, Jackson BT, Wescott AB, Ellis MF. "Post Mastectomy Pain Syndrome: A Systematic Review of Prevention Modalities". JPRAS Open. 2021 Oct 30;31:32-49. doi: 10.1016/j.jpra.2021.10.009. eCollection 2022 Mar.
- Background: PubMed 27668333Waltho D, Rockwell G. Post-breast surgery pain syndrome: establishing a consensus for the definition of post-mastectomy pain syndrome to provide a standardized clinical and research approach - a review of the literature and discussion. Can J Surg. 2016 Sep;59(5):342-50. doi: 10.1503/cjs.000716.
- Background: PubMed 32443289Gong Y, Tan Q, Qin Q, Wei C. Prevalence of postmastectomy pain syndrome and associated risk factors: A large single-institution cohort study. Medicine (Baltimore). 2020 May;99(20):e19834. doi: 10.1097/MD.0000000000019834.
- Background: PubMed 34826113Xin L, Hou N, Zhang Z, Feng Y. The Effect of Preoperative Ultrasound-Guided Erector Spinae Plane Block on Chronic Postsurgical Pain After Breast Cancer Surgery: A Propensity Score-Matched Cohort Study. Pain Ther. 2022 Mar;11(1):93-106. doi: 10.1007/s40122-021-00339-9. Epub 2021 Nov 26.
- Background: PubMed 33560352Zinboonyahgoon N, Patton ME, Chen YK, Edwards RR, Schreiber KL. Persistent Post-Mastectomy Pain: The Impact of Regional Anesthesia Among Patients with High vs Low Baseline Catastrophizing. Pain Med. 2021 Aug 6;22(8):1767-1775. doi: 10.1093/pm/pnab039.
- Background: PubMed 21804697Batra RK, Krishnan K, Agarwal A. Paravertebral block. J Anaesthesiol Clin Pharmacol. 2011 Jan;27(1):5-11. No abstract available.
- Background: PubMed 33340344Bonvicini D, Boscolo-Berto R, De Cassai A, Negrello M, Macchi V, Tiberio I, Boscolo A, De Caro R, Porzionato A. Anatomical basis of erector spinae plane block: a dissection and histotopographic pilot study. J Anesth. 2021 Feb;35(1):102-111. doi: 10.1007/s00540-020-02881-w. Epub 2020 Dec 19.
- Background: PubMed 31879425El Ghamry MR, Amer AF. Role of erector spinae plane block versus paravertebral block in pain control after modified radical mastectomy. A prospective randomised trial. Indian J Anaesth. 2019 Dec;63(12):1008-1014. doi: 10.4103/ija.IJA_310_19. Epub 2019 Dec 11.
- Comparative study between ultrasound guided erector spinae plane block versus paravertebral block for postoperative pain relief in patients undergoing unilateral modified radical mastectomy.AIMJ.2022.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Study protocol will be shared
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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.
Suzan Ahmed, MS degree principal investigator
National Cancer Institute, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paravertebral plane block, Erector spinae plane block and Intravenous morphine, ketorlac and paracetamol in people with Chronic Postoperative Pain, run by National Cancer Institute, Egypt 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 3 inclusion and 8 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 28 Jun 2024. 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. 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 Suzan Ahmed, MSc (00201004610287, suzansayed@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is to assess the incidence of PMPS 3 months after surgery. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06036979, which also lists 9 linked publications.
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 28 Jun 2024.