Effectiveness of Combined Erector Spinae and Pecto-intercostal Fascial Plane Blocks Versus Thoracic Paravertebral Block in Perioperative Pain in Modified Radical Mastectomy

NCT04778267 | Completed Phase 4

• 1 other identifier: MD-342-2020
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Erector spinae plane block (ESPB) is a new evolving fascial pain block in the era of regional anaesthesia. ESPB was applied in varieties of surgeries and provided an eminent role in trauma patient especially those with fracture ribs. ESPB exhibits simple, safe and easy technique with minimal or no sympathetic blockade effects, thus gaining popularity in wide range of surgeries. The optimum effective dose of local anaesthetic, the effective volume of drug used for desired dermatomes. Comparison with different regional blocks is preferable to know the optimum analgesic technique for those population of patients (4). Many studies have already compared solo ESPB with thoracic epidural analgesia (TEA), thoracic paravertebral block (TPVB), serratus anterior plane block (SAPB) and pectoral nerves block. Only few case reports described the combination effect of rhomboid intercostal, transversus thoracic muscle and parasternal plane blocks to ESPB in modified radical mastectomy.

Conditions

Modified Radical Mastectomy

Outcome Measures

Primary Outcomes (1)

• The first time to ask for rescue analgesia post-operatively

  after how many hours postoperatively the patient will ask for analgesia

  48 hours

Secondary Outcomes (2)

• The total postoperative opioid consumption (in the first 48 hrs)

  48 hours

• NRS scores

  48 hours postoperative

Study Arms (2)

TPVB (thoracic paravertebral block)

ACTIVE COMPARATOR

TPVB will be performed in the sitting position A high frequency linear ultrasound probe will be applied in the parasagittal plane approximately 2-3 cm lateral to the midline till identification of the 3rd thoracic vertebra (T3) in the same side of surgery. Then the transducer will be moved progressively more medially until transverse processes are identified.The image acquired will have the transverse process located superiorly and an image of lower rib located inferiorly on the screen.The needle tip is to be observed to enter through the superior costotransverse ligament and loss of resistance sensation will be experienced. After confirming the anterior displacement of pleura with 2-3 mL of local anesthetic (LA), 30 ml of 0.25% bupivacaine and 4 mg dexamethasone will be administered for the block.

Drug: Bupivacaine Hydrochloride; Drug: Dexamethasone phosphate

ES-PI (erector spinae-pectointercostal block)

EXPERIMENTAL

ESPB In the second group (ES-PI) Using a high frequency linear ultrasound probe, it will be located in a longitudinal orientation at the level of T3 spinous process and then will be placed 3 cm laterally from the midline to the side involved in the surgery. .a 22-gauge block needle will be inserted in-plane at an angle of 30-40°. 20 mL of 0.25% bupivacaine hydrochloride and 3 mg dexamethasone will be injected in the plane deeper to the erector spinae muscle. PIPB While the patient is in the supine position, a high frequency linear probe will be placed parallel to the long axis of the sternum at a distance 2-3 cm from the attachment of the second rib and sternum to identify the Pectoralis major muscle, external intercostal muscles and the second rib in the superficial plane. by separation of fascial layers of between the external intercostal and the pectoralis muscles, a total of 10 ml of 0.25% bupivacaine and 1 mg dexamethasone will be injected.

Drug: Bupivacaine Hydrochloride; Drug: Dexamethasone phosphate

Interventions

Bupivacaine Hydrochloride DRUG

We hypothesize that combined ESPB and PIPB are as effective as TPVB in controlling perioperative pain in patients undergoing modified radical mastectomy (MRM) with lesser complications using bupivacaine hydrocloride

Also known as: marcaine

ES-PI (erector spinae-pectointercostal block); TPVB (thoracic paravertebral block)

Dexamethasone phosphate DRUG

used as additive to bupivacaine

Also known as: decadrone

ES-PI (erector spinae-pectointercostal block); TPVB (thoracic paravertebral block)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 18-60 years of age
• ASA I-II
• Elective unilateral modified radical mastectomy with axillary lymph node dissection
• Body weight (50-90 kg)

You may not qualify if:

• Patient refusal
• Known allergy to any of the study drugs
• Bleeding disorders (platelets \< 50 000, PC \<60%, INR\>1.5)
• Infection at the site of needle puncture or sepsis
• Obesity (BMI \> 30 kg/m2)
• Chronic opioid user eg; morphine addict
• Chronic pain disease eg certain cancer patients, rheumatological disease
• Inability to comprehend or use the numeric rating pain scoring system
• Psychiatric illness eg, psychiatric patients on hypnotic treatment

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kase Al Aini teaching hospital

Cairo, Kasr Al Aini, 2222, Egypt

Location

MeSH Terms

Interventions

Bupivacaine; dexamethasone 21-phosphate

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: randomization table created by a researcher who is not involved in the study. The researcher will assign the random ID to each patient and a blinded anesthesiologist will use this ID while collecting the postoperative data in the surgical ward. The block interventions of this study will be done by the same anesthesiologist (well trained to use US-guided regional techniques) while pre-operative and postoperative data collection will be done by another anesthesiologist blinded to the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: The effectiveness of combined ultrasound guided erector spinae and pectointercostal fascial plane blocks versus ultrasound guided thoracic paravertebral block in controlling perioperative pain in modified radical mastectomy, a blinded randomized controlled trial

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: March 3, 2021
• Study Start: March 12, 2021
• Primary Completion: March 9, 2023
• Study Completion: March 10, 2023
• Last Updated: March 13, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)