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A Comparative Study Between the Effectiveness of Preoperative ESPB Versus Preoperative PVPB in Decreasing PMPS. A Randomized Controlled Study

Primary Purpose

Chronic Postoperative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Paravertebral plane block
Erector spinae plane block
Sponsored by
National Cancer Institute, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Postoperative Pain focused on measuring PVPB, ESPB, prevention of PMPS

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Age ≥ 18 years and ≤ 60 years old. Female patients ASA ΙΙ, ΙΙΙ. Female patients scheduled for unilateral breast surgeries. Exclusion Criteria: 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.

Sites / Locations

  • NCIEGYPTRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Paravertebral Block Group

Erector Spinae Block Group

Control Group

Arm Description

This group will receive combined general anaesthesia with preoperative ultrasound guide paravertebral plane block

This group will receive combined general anaesthesia with preoperative ultrasound guided erector spinae plane block

This group will receive balanced general anesthesia using intravenous (0.1mg/kg) morphine, 30 mg ketorlac and 1 gm paracetamol).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

• The prevalence of PMPS at 6 months.
• The prevalence of PMPS at 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.
• 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.
• PVPB and ESPB related complications.
• PVPB and ESPB related complications (bupivacaine toxicity, pneumothorax).

Full Information

First Posted
September 7, 2023
Last Updated
September 7, 2023
Sponsor
National Cancer Institute, Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT06036979
Brief Title
A Comparative Study Between the Effectiveness of Preoperative ESPB Versus Preoperative PVPB in Decreasing PMPS. A Randomized Controlled Study
Official Title
A Comparative Study Between the Effectiveness of Preoperative Erector Spinae Plane Block Versus Preoperative Paravertebral Plane Block in Decreasing Post Mastectomy Pain Syndrome. A Randomized Controlled Study.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute, Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Postoperative Pain
Keywords
PVPB, ESPB, prevention of PMPS

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Paravertebral Block Group
Arm Type
Active Comparator
Arm Description
This group will receive combined general anaesthesia with preoperative ultrasound guide paravertebral plane block
Arm Title
Erector Spinae Block Group
Arm Type
Active Comparator
Arm Description
This group will receive combined general anaesthesia with preoperative ultrasound guided erector spinae plane block
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
This group will receive balanced general anesthesia using intravenous (0.1mg/kg) morphine, 30 mg ketorlac and 1 gm paracetamol).
Intervention Type
Procedure
Intervention Name(s)
Paravertebral plane block
Other Intervention Name(s)
PVPB
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Erector spinae plane block
Other Intervention Name(s)
ESPB
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary outcome is to assess the incidence of PMPS 3 months after surgery.
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
• The prevalence of PMPS at 6 months.
Description
• The prevalence of PMPS at 6 months.
Time Frame
6 months
Title
• Assessment of acute postoperative pain.
Description
• 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.
Time Frame
48 hours
Title
• Time to first needed morphine dose postoperatively, total 24-48 hours morphine consumption.
Description
• Time to first needed morphine dose postoperatively, total 24-48 hours morphine consumption.
Time Frame
48 hours .
Title
• PVPB and ESPB related complications.
Description
• PVPB and ESPB related complications (bupivacaine toxicity, pneumothorax).
Time Frame
24 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female patients ASA ΙΙ, ΙΙΙ between 18 and 60 years undergoing unilateral breast surgeries.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years and ≤ 60 years old. Female patients ASA ΙΙ, ΙΙΙ. Female patients scheduled for unilateral breast surgeries. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suzan Ahmed, MS degree in Anaesthesia
Phone
00201004610287
Email
suzansayed@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzan Ahmed, MS degree
Organizational Affiliation
National Cancer Institute, Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
NCIEGYPT
City
Cairo
ZIP/Postal Code
11796
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Study protocol will be shared
IPD Sharing Time Frame
20 years
IPD Sharing Access Criteria
Clinical trials.gov
IPD Sharing URL
http://clinicaltrials.gov
Citations:
PubMed Identifier
33414157
Citation
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.
Results Reference
background
PubMed Identifier
34926777
Citation
Yuksel 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.
Results Reference
background
PubMed Identifier
27668333
Citation
Waltho 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.
Results Reference
background
PubMed Identifier
32443289
Citation
Gong 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.
Results Reference
background
PubMed Identifier
34826113
Citation
Xin 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.
Results Reference
background
PubMed Identifier
33560352
Citation
Zinboonyahgoon 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. Erratum In: Pain Med. 2022 Jan 3;23(1):225.
Results Reference
background
PubMed Identifier
21804697
Citation
Batra RK, Krishnan K, Agarwal A. Paravertebral block. J Anaesthesiol Clin Pharmacol. 2011 Jan;27(1):5-11. No abstract available.
Results Reference
background
PubMed Identifier
33340344
Citation
Bonvicini 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.
Results Reference
background
PubMed Identifier
31879425
Citation
El 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.
Results Reference
background
Links:
URL
https://aimj.journals.ekb.eg/article_230793.html
Description
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.

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A Comparative Study Between the Effectiveness of Preoperative ESPB Versus Preoperative PVPB in Decreasing PMPS. A Randomized Controlled Study

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