Preoperative Erector Spinae Plane Block Versus Paravertebral Plane Block in Decreasing Post Mastectomy Pain Syndrome

NCT06036979 | Not Yet Recruiting DMC

• 1 other identifier: AP2303-301-0007
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Postoperative Pain

Keywords

PVPB, ESPB, prevention of PMPS

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (4)

• • The prevalence of PMPS at 6 months.

  6 months

• • Assessment of acute postoperative pain.

  48 hours

• • Time to first needed morphine dose postoperatively, total 24-48 hours morphine consumption.

  48 hours .

• • PVPB and ESPB related complications.

  24 hours

Study Arms (3)

Paravertebral Block Group

ACTIVE COMPARATOR

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

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

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).

Drug: Intravenous morphine, ketorlac and paracetamol

Interventions

Paravertebral plane block PROCEDURE

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.

Also known as: PVPB

Paravertebral Block Group

Erector spinae plane block PROCEDURE

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.

Also known as: ESPB

Erector Spinae Block Group

Intravenous morphine, ketorlac and paracetamol DRUG

• In the control group only we add 10mg intravenous morphine, 30 mg intravenous ketorlac and 1 gm intravenous paracetamol for analgesia.

Also known as: IV analgesics

Control Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Female patients ASA ΙΙ, ΙΙΙ between 18 and 60 years undergoing unilateral breast surgeries.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

NCIEGYPT

Cairo, 11796, Egypt

Location

Related Publications (9)

• 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.

  PMID: 33414157 BACKGROUND

• 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.

  PMID: 34926777 BACKGROUND

• 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.

  PMID: 27668333 BACKGROUND

• 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.

  PMID: 32443289 BACKGROUND

• 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.

  PMID: 34826113 BACKGROUND

• 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.

  PMID: 33560352 BACKGROUND

• Batra RK, Krishnan K, Agarwal A. Paravertebral block. J Anaesthesiol Clin Pharmacol. 2011 Jan;27(1):5-11. No abstract available.

  PMID: 21804697 BACKGROUND

• 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.

  PMID: 33340344 BACKGROUND

• 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.

  PMID: 31879425 BACKGROUND

Related Links

• 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.

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acetaminophen; Analgesics

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Suzan Ahmed, MS degree

  National Cancer Institute, Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suzan Ahmed, MSc

CONTACT

00201004610287; suzansayed@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: September 14, 2023
• Study Start: July 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: February 1, 2025
• Last Updated: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 20 years
• Access Criteria: Clinical trials.gov

Locations

EG (1)