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The Impact of Pecs Blocks on Postmastectomy Pain Syndrome

Primary Purpose

Pain Syndrome, Pain, Postoperative, Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Pecs block
no Pecs block
Sponsored by
Aretaieion University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain Syndrome

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) I-III patients
  • Breast cancer patients
  • Patients who receive operative treatment

Exclusion Criteria:

  • inability to consent to the study due to language barriers or cognitive dysfunction -
  • skin infection at the puncture site
  • contraindication to paracetamol administration
  • known previous hepatic or renal impairment as assessed by the patients' history and routine biochemical markers

Sites / Locations

  • General Hospital of Limassol
  • General Hospital of Nicosia
  • Aretaieion University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

study group

control group

Arm Description

Pecs block under real-time ultrasound guidance after anesthesia induction will be performed. In specific, using the in-plane insertion technique, after visualization of the entire needle as a bright hyperechoic line and aiming between pectoralis major and pectoralis minor at the 3rd rib level, 2 ml of normal saline 09% will be injected first, to verify the correct position of the needle. Followingly, 10 mL ropivacaine 0.5% will be injected in order to block the lateral and medial pectoral nerves. Finally, another 15 ml of ropivacaine 0.5% plus 4 mg of dexamethasone will be injected between the pectoralis minor muscle and the anterior serratus muscle,at the level of the 4th and 5th ribs, after negative aspiration, to block the intercostal and intercostobrachial nerves. Using the color Doppler the vessels will be identified, so that their puncture is avoided during the procedures.

no regional block will be performed

Outcomes

Primary Outcome Measures

pain score 6 hours postoperatively
pain score by the use of Numeric Rating Scale (NRS) 6 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
pain score 12 hours postoperatively
pain score by the use of Numeric Rating Scale (NRS) 12 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
pain score 24 hours postoperatively
pain score by the use of Numeric Rating Scale (NRS) 24 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

Secondary Outcome Measures

incidence of chronic pain
occurrence of chronic pain at the site of the operation 3 months after surgery, with the use of the Numeric Rating Scale (NRS), at rest and during movement
incidence of chronic pain
occurrence of chronic pain at the site of the operation 6 months after surgery, with the use of the Numeric Rating Scale (NRS), at rest and during movement
time of first request for analgesia
time of first request for analgesia after the operation
analgesic consumption in mg of morphine
additional analgesic consumption in the first 24 hours after the operation
satisfaction from postoperative analgesia
satisfaction from postoperative analgesia on a four-point Likert scale with 1 marked as minimal satisfaction and 4 as maximal satisfaction
Pecs block related complications
Pecs block-related complications at the site of the local anesthetic injection

Full Information

First Posted
October 6, 2020
Last Updated
February 5, 2023
Sponsor
Aretaieion University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04586751
Brief Title
The Impact of Pecs Blocks on Postmastectomy Pain Syndrome
Official Title
The Impact of Pecs Blocks on the Appearance of Post Mastectomy Chronic Pain Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
March 31, 2022 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
The aim of the present study is to investigate the incidence of chronic pain following breast cancer surgery in Cyprus, discover its associated risk factors and explore the impact of Pecs Blocks on the appearance of post mastectomy chronic pain symptoms
Detailed Description
Breast cancer is the commonest type of malignancy in women. Chronic postoperative neuropathic pain may appear either in the early postoperative period or at a later stage, usually 3-6 months post-operatively. Chronic post-operative pain syndrome of any magnitude usually involves 19-57% of patients that have undergone any kind of surgical procedure, while 5% of them experience intense symptoms. Risk factors for developing post-mastectomy pain syndrome include younger age, increased Body mass Index (BMI), psychological profile, co-existence of other painful conditions, pre-operative radiotherapy/chemotherapy, type of surgical procedure and anaesthesia, persistent acute postoperative pain, etc. Consequently, chronic post mastectomy pain syndrome results in significant psychosomatic sequelae with variable social impacts for the female patients. The aim of the present study will be to investigate the incidence of chronic pain following breast cancer surgery in Cyprus, discover its associated risk factors and explore the impact of Pecs Blocks on the appearance of post mastectomy chronic pain symptoms. During the preoperative visit, the women will be informed about the study and will be instructed to the use of the pain numeric rating scale (NRS) graded from 0 to 10. Standardized anesthesia will be administered. All patients will receive 1000 mg of paracetamol and 0.07 mg/ Kg of morphine intraoperatively. In the Post-Anesthesia Care Unit (PACU), patients will receive additional morphine boluses on request, until NRS score is lesser or equal than 4. Postoperative nausea and vomiting will be treated with ondansetron 4 mg iv. After discharge from PACU, patients will receive a combination of paracetamol 1 gr/6h and im pethidine 75 mg on request, as per hospital protocol. Numerical rating scores (NRS) at rest and movement will be measured at 6h, 12h and 24h postoperatively. Additionally, the time to first request for analgesia after surgery will be noted. All patients will also be evaluated 3 and 6 months after surgery with the use of NRS at rest and movement and additionally, via the use of Douleur Neuropathique (DN4) questionnaire for the occurence of neuropathic pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Syndrome, Pain, Postoperative, Chronic Pain, Breast Cancer, Breast Soft Tissue Neoplasm, Breast Neoplasms, Breast Cancer Female, Breast Pain, Anesthesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Active Comparator
Arm Description
Pecs block under real-time ultrasound guidance after anesthesia induction will be performed. In specific, using the in-plane insertion technique, after visualization of the entire needle as a bright hyperechoic line and aiming between pectoralis major and pectoralis minor at the 3rd rib level, 2 ml of normal saline 09% will be injected first, to verify the correct position of the needle. Followingly, 10 mL ropivacaine 0.5% will be injected in order to block the lateral and medial pectoral nerves. Finally, another 15 ml of ropivacaine 0.5% plus 4 mg of dexamethasone will be injected between the pectoralis minor muscle and the anterior serratus muscle,at the level of the 4th and 5th ribs, after negative aspiration, to block the intercostal and intercostobrachial nerves. Using the color Doppler the vessels will be identified, so that their puncture is avoided during the procedures.
Arm Title
control group
Arm Type
Sham Comparator
Arm Description
no regional block will be performed
Intervention Type
Other
Intervention Name(s)
Pecs block
Intervention Description
Pecs block under real-time ultrasound guidance after anesthesia induction will be performed.
Intervention Type
Other
Intervention Name(s)
no Pecs block
Intervention Description
no regional block will be performed in this arm
Primary Outcome Measure Information:
Title
pain score 6 hours postoperatively
Description
pain score by the use of Numeric Rating Scale (NRS) 6 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
Time Frame
6 hours after surgery
Title
pain score 12 hours postoperatively
Description
pain score by the use of Numeric Rating Scale (NRS) 12 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
Time Frame
12 hours after surgery
Title
pain score 24 hours postoperatively
Description
pain score by the use of Numeric Rating Scale (NRS) 24 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
incidence of chronic pain
Description
occurrence of chronic pain at the site of the operation 3 months after surgery, with the use of the Numeric Rating Scale (NRS), at rest and during movement
Time Frame
3 months after surgery
Title
incidence of chronic pain
Description
occurrence of chronic pain at the site of the operation 6 months after surgery, with the use of the Numeric Rating Scale (NRS), at rest and during movement
Time Frame
6 months after surgery
Title
time of first request for analgesia
Description
time of first request for analgesia after the operation
Time Frame
24 hours postoperatively
Title
analgesic consumption in mg of morphine
Description
additional analgesic consumption in the first 24 hours after the operation
Time Frame
24 hours postoperatively
Title
satisfaction from postoperative analgesia
Description
satisfaction from postoperative analgesia on a four-point Likert scale with 1 marked as minimal satisfaction and 4 as maximal satisfaction
Time Frame
24 hours postoperatively
Title
Pecs block related complications
Description
Pecs block-related complications at the site of the local anesthetic injection
Time Frame
48 hours postoperatively

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists (ASA) I-III patients Breast cancer patients Patients who receive operative treatment Exclusion Criteria: inability to consent to the study due to language barriers or cognitive dysfunction - skin infection at the puncture site contraindication to paracetamol administration known previous hepatic or renal impairment as assessed by the patients' history and routine biochemical markers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kassiani Theodoraki
Organizational Affiliation
Aretaieion University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Hospital of Limassol
City
Limassol
Country
Cyprus
Facility Name
General Hospital of Nicosia
City
Nicosia
Country
Cyprus
Facility Name
Aretaieion University Hospital
City
Athens
ZIP/Postal Code
115 28
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25376971
Citation
Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163.
Results Reference
background
PubMed Identifier
30386013
Citation
Thomas M, Philip FA, Mathew AP, Jagathnath Krishna KM. Intraoperative pectoral nerve block (Pec) for breast cancer surgery: A randomized controlled trial. J Anaesthesiol Clin Pharmacol. 2018 Jul-Sep;34(3):318-323. doi: 10.4103/joacp.JOACP_191_17.
Results Reference
background
PubMed Identifier
24796220
Citation
Sykioti P, Zis P, Vadalouca A, Siafaka I, Argyra E, Bouhassira D, Stavropoulou E, Karandreas N. Validation of the Greek Version of the DN4 Diagnostic Questionnaire for Neuropathic Pain. Pain Pract. 2015 Sep;15(7):627-32. doi: 10.1111/papr.12221. Epub 2014 May 5.
Results Reference
background
PubMed Identifier
20562750
Citation
Bras M, Dordevic V, Gregurek R, Bulajic M. Neurobiological and clinical relationship between psychiatric disorders and chronic pain. Psychiatr Danub. 2010 Jun;22(2):221-6.
Results Reference
background
PubMed Identifier
28949315
Citation
Dujmovic A, Marcinko D, Bulic K, Kisic H, Dudukovic M, Mijatovic D. Quality of Life and Depression Among Female Patients Undergoing Surgical Treatment for Breast Cancer: A Prospective Study. Psychiatr Danub. 2017 Sep;29(3):345-350. doi: 10.24869/psyd.2017.345.
Results Reference
background
PubMed Identifier
20832052
Citation
Khan RS, Ahmed K, Blakeway E, Skapinakis P, Nihoyannopoulos L, Macleod K, Sevdalis N, Ashrafian H, Platt M, Darzi A, Athanasiou T. Catastrophizing: a predictive factor for postoperative pain. Am J Surg. 2011 Jan;201(1):122-31. doi: 10.1016/j.amjsurg.2010.02.007. Epub 2010 Sep 15.
Results Reference
background
PubMed Identifier
31564259
Citation
Najeeb HN, Mehdi SR, Siddiqui AM, Batool SK. Pectoral Nerves I, II and Serratus Plane Blocks in Multimodal Analgesia for Mastectomy: A Randomised Clinical Trial. J Coll Physicians Surg Pak. 2019 Oct;29(10):910-914. doi: 10.29271/jcpsp.2019.10.910.
Results Reference
background
Links:
URL
http://www.painconcern.org.uk
Description
contains news, features and comments on every topic that matters to the pain community

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The Impact of Pecs Blocks on Postmastectomy Pain Syndrome

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