Serratus Plane Block Versus Serratus Plane Block Plus Parasternal Block Combination for Breast Surgery

Sponsor

Ataturk University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05911373

Collaborator

(none)

Enrollment

Location

Arms

6.8

Anticipated Duration (Months)

9.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Mastectomy is a technique often used in breast cancer surgery. Patients experience moderate to severe pain postoperatively after this procedure. Various plane blocks, NSAIDs, and opioid analgesics can be administered to these patients as components of multimodal analgesia. In the the study, the investigators aimed to evaluate the analgesic effects of the serratus plane block, the parasternal block added to the serratus plane block, and the dermatomal differences.

Condition or Disease	Intervention/Treatment	Phase
Analgesia Cancer, Breast	Other: group serratus plan block Other: group serratus and parasternal plan block	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Serratus Plane Block Versus Serratus Plane Block Plus Parasternal Block on Postoperative Opioid Consumption and Dermatomal Analyses for Breast Surgery

Actual Study Start Date :

Jun 21, 2023

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: group serratus preoperative superficial serratus block with local anaesthetics and parasternal block with saline	Other: group serratus plan block preoperativelly, Superficial Serratus Block performed with 30 ml %0.25 Bupivacaine and Parasternal Block performed with 10 ml saline
Active Comparator: group serratus and parasternal preoperative superficial serratus block and parasternal block with local anaesthetics	Other: group serratus and parasternal plan block preoperativelly, Superficial Serratus Block performed with 30 ml %0.25 Bupivacaine and Parasternal Block performed with 10 ml %0.25 Bupivacaine

Arm

Intervention/Treatment

Placebo Comparator: group serratus

preoperative superficial serratus block with local anaesthetics and parasternal block with saline

Other: group serratus plan block

preoperativelly, Superficial Serratus Block performed with 30 ml %0.25 Bupivacaine and Parasternal Block performed with 10 ml saline

Active Comparator: group serratus and parasternal

preoperative superficial serratus block and parasternal block with local anaesthetics

Other: group serratus and parasternal plan block

preoperativelly, Superficial Serratus Block performed with 30 ml %0.25 Bupivacaine and Parasternal Block performed with 10 ml %0.25 Bupivacaine

Outcome Measures

Primary Outcome Measures

Postoperative opioid consumption [first 24 hours]
First 24 hours total fentanyl consumption with patient controlled analgesia

Secondary Outcome Measures

Visual analog pain score [First 24 hours]
Post operative pain will be evaluated with a Visual Analogue Scale (between 0-10; 0: no pain, 10:worst pain) score
Sensory Assessment [24 hours]
Sensory Assessment will be performed on patients following the block procedure with pinprick test.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

American Society of Anesthesiologist's physiologic state I-III patients
To undergo Mastectomy Surgery
Being between the ages of 18-65 years

Exclusion Criteria:

Having a known heart, kidney, liver or hematological disease
Having a history of peptic ulcer, gastrointestinal bleeding, allergy, chronic pain
Routine analgesic use and history of analgesic use in the last 24 hours
Not willing to participate in the study
Uncooperative patients who have coagulopathy or use anticoagulant drugs
To be allergic to one of the drugs to be used

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ali Ahiskalioglu	Erzurum		Turkey	25100

Sponsors and Collaborators

Ataturk University

Investigators

Study Director: Hüsnü Kürşad, Ataturk University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Ali Ahiskalioglu, Principal Investigator, Ataturk University

ClinicalTrials.gov Identifier:

NCT05911373

Other Study ID Numbers:

ataunibreastanalgesia

First Posted:

Jun 22, 2023

Last Update Posted:

Jun 22, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Jun 22, 2023