The Mid-point Transverse Process to Pleura Block Versus Serratus Anterior Plane Block for Postoperative Analgesia After Modified Radical Mastectomy

NCT06625879 | Not Yet Recruiting DMC

• 1 other identifier: FMASU MD325/2023
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Several studies proved that the serratus anterior plane block(SAPB) offer analgesia not inferior or as effective to opioids which is mainstay of analgesia (chai et al., 2023). In this study we will compare the analgesic effect of the serratus anterior plane block versus a new paraspinal technique block which is the midpoint transverse process to pleura (MTP) block for postoperative analgesia after modefied radical mastectomy.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• the mean duration to require first rescue analgesia which will be (Diclofenac 75mg) when NRS pain score ≥4 at rest.

  the mean duration to require first rescue analgesia which will be (Diclofenac 75mg) when NRS pain score ≥4 at rest. If no response within 1 hour pethidine 50mg IM will be given. If NRS pain score is ≥4 at rest after 2 hours another dose of pethidine 25mg IM will be given.

  24 hours post- operative

Secondary Outcomes (1)

• The total number of doses of the rescue analgesia that will be received in the 24 hours postoperatively if the NRS pain score at rest ≥4

  24 hours post- operative

Study Arms (2)

Group I: (Serratus Anterior Plane Block (SAPB) Group) (n=15)

ACTIVE COMPARATOR

Group I: (Serratus Anterior Plane Block (SAPB) Group) (n=15): The patient will lay on her side with arm brought forward, the linear US transducer probe (10-12 MHz) will be placed in the midaxillary line and then moved caudal from second rib until the sixth intercostal space. At this point, the subcutaneous tissue and serratus muscle will be identified in the superficial plane, whereas the external intercostal muscles will be identified in the intermediate plane and finally in the deep plane the ribs, pleura and lung will be identified. The needle will be advanced from caudal to cranial direction. In-plane technique will be used until the tip of the needle placed between the serratus anterior muscle and the external intercostal muscle (deep SABP) (Blanco et al., 2013). A volume of titrated bolus of 20 ml of bupivacaine 0.5% will be injected after aspiration to avoid intravascular injection (Lin J et al., 2020).

Procedure: Serratus Anterior Plane Block (SAPB)

GroupII: (Midpoint transverse process to pleura (MTP) block group )(n=15)

ACTIVE COMPARATOR

GroupII: (Midpoint transverse process to pleura (MTP) block group )(n=15): In the lateral postion, the T4 spine will be counted by ultrasound, and high frequency linear US transducer probe (10-12 MHz) will be placed longitudinally, approximately 2.5 cm lateral to the midline the needle will be advanced in plane from cranial to caudal direction. The desired end point for the needle tip will be the midpoint of the line between the posterior border of the transverse process of T4 and the pleura(injection will be deep (anterior) to the posterior aspect of the vertebral transverse process but superficial to the superior costotransverse ligment),the needle tip dose not enter the paravertebral space (Chin et al., 2021), a volume of titrated bolus of 20 ml of bupivacaine 0.5% will be injected after aspiration to avoid intravascular injection,pleural displacement and bowing of erector spinae will be observed at the side of injection (Syal et al., 2020; Pusch et al., 2000).

Procedure: Midpoint transverse process to pleura (MTP) block

Interventions

Serratus Anterior Plane Block (SAPB) PROCEDURE

Group I: (Serratus Anterior Plane Block (SAPB) Group) (n=15): The patient will lay on her side with arm brought forward, the linear US transducer probe (10-12 MHz) will be placed in the midaxillary line and then moved caudal from second rib until the sixth intercostal space. At this point, the subcutaneous tissue and serratus muscle will be identified in the superficial plane, whereas the external intercostal muscles will be identified in the intermediate plane and finally in the deep plane the ribs, pleura and lung will be identified. The needle will be advanced from caudal to cranial direction. In-plane technique will be used until the tip of the needle placed between the serratus anterior muscle and the external intercostal muscle (deep SABP) . A volume of titrated bolus of 20 ml of bupivacaine 0.5% will be injected after aspiration to avoid intravascular injection.

Group I: (Serratus Anterior Plane Block (SAPB) Group) (n=15)

Midpoint transverse process to pleura (MTP) block PROCEDURE

In the lateral postion, the T4 spine will be counted by ultrasound, and high frequency linear US transducer probe (10-12 MHz) will be placed longitudinally, approximately 2.5 cm lateral to the midline the needle will be advanced in plane from cranial to caudal direction. The desired end point for the needle tip will be the midpoint of the line between the posterior border of the transverse process of T4 and the pleura(injection will be deep (anterior) to the posterior aspect of the vertebral transverse process but superficial to the superior costotransverse ligment),the needle tip dose not enter the paravertebral space , a volume of titrated bolus of 20 ml of bupivacaine 0.5% will be injected after aspiration to avoid intravascular injection,pleural displacement and bowing of erector spinae will be observed at the side of injection .

GroupII: (Midpoint transverse process to pleura (MTP) block group )(n=15)

Eligibility Criteria

• Age: 35 Years - 60 Years
• Gender Eligibility Details: Patients will undergoing modefied radical mastectomy
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female patients undergoing unilateral Modified Radical Mastectomy. Physical status: ASA grades I and II. Age between 35 and 60 years old.

You may not qualify if:

• Known Allergy to one of the study drugs. Asthmatic patients. Patients undergoing bilateral Modified Radical Mastectomy. Patients refusal of procedure or participation in the study. ASA classes III or above. Local skin infection at the site of the block. Pregnant Patients. Other malignancy. History or evidence of coagulopathy. History of use of anti coagulant or anti platelet therapy. Body mass index ≥40 kg/m2.

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Central Study Contacts

Alaa A Hassan, Master degree

CONTACT

alaaashrafhasan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 3, 2024
• Study Start: October 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: October 3, 2024

Record last verified: 2024-10