Comparison of Serratus Anterior Plane Block and the Combination of Serratus Anterior Plane Block and Transversus Thoracis Plane Block in Breast Cancer Surgery

Sponsor
Bezmialem Vakif University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06082141
Collaborator
(none)
60
1
2
10.7
5.6

Study Details

Study Description

Brief Summary

Breast cancer is the most common malignancy in women worldwide. Even minor breast surgery can cause significant postoperative pain (PP). PP can turn into chronic pain in 25-40% of cases. Inadequate PP control is associated with increased morbidity, delayed wound healing, prolonged hospital stay, increased opioid use and side effects, and high cost of care.

Opioid use remains the mainstay of postoperative analgesia. Opioids, especially morphine, inhibit both cellular and humoral immune functions. This effect may be responsible for the high rates of local recurrence and/or metastasis after surgery. Additionally, studies have shown that perioperative opioid use is associated with social abuse. This demonstrates the importance of reducing perioperative opioid use. Currently, multimodal analgesia based on nerve block is being widely investigated and has shown encouraging clinical results.

Numerous regional analgesic techniques have been investigated in breast cancer surgery, including intercostal nerve block, thoracic epidural anesthesia, and paravertebral block. Compared with general anesthesia alone, it reduces the postoperative pain score even after a single-shot injection for up to 72 hours, reduces opioid consumption, improves the quality of patient recovery, and suppresses the development or reduces the severity of chronic pain.

Serratus anterior plane block (SAPB) is reported to be effective in perioperative pain management of breast cancer surgeries. The important problem of SAPB block is that it is insufficient to block the anterior cutaneous branches of the intercostal nerves. Therefore, intravenous analgesia is required. Thoracic transversus muscle plane block (TTPB) is a recently described fascial plane block used to anesthetize the anterior cutaneous branches of the intercostal nerves from T2-T6. Its effectiveness has been demonstrated for breast surgery and median sternotomy.

In our study, we will provide postoperative analgesia in patients undergoing breast surgery by applying the serratus anterior block in combination with the transversus thoracis plane block. Since we avoid complicated analgesia methods such as paravertebral block, the risk of complications will be reduced.

In this study, we aimed to compare the effectiveness of the combination of SAPB and TTPB with SAPB performed alone in breast cancer surgery.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Transversus thoracis plane block combined with serratus anterior plane block
  • Procedure: Serratus anterior plan block
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of the Effect of Serratus Anterior Plane Block and the Combination of Serratus Anterior Plane Block and Transversus Thoracis Plane Block on the Recovery Quality 15 Score in Breast Cancer Surgery: a Double-blind Randomized Controlled Study
Actual Study Start Date :
Jul 12, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Ultrasound guided serratus anterior plane block

SAP block will be made with 10 ml 0.5% bupivacaine + 10 ml NaCl TTP block will be made with 10 ml NaCl

Procedure: Serratus anterior plan block
SAP block will be made with 10 ml 0.5% bupivacaine + 10 ml NaCl under US-guidance, TTP block will be made with 10 ml NaCl under US-guidance

Active Comparator: Combination of ultrasound-guided serratus anterior plane block and transversus thoracis plane block

SAP block will be made with 10 ml 0.5% bupivacaine + 10 ml NaCl TTP block will be made with 5 ml 0.5% bupivacaine + 5 ml NaCl

Procedure: Transversus thoracis plane block combined with serratus anterior plane block
SAP block will be made with 10 ml 0.5% bupivacaine + 10 ml NaCl under US-guidance, TTP block will be made with 5 ml 0.5% bupivacaine + 5 ml NaCl under US-guidance

Outcome Measures

Primary Outcome Measures

  1. Quality of recovery-15 (QoR-15) score [at the end of 24 hours postoperatively]

    Quality of recovery-15 (QoR-15) score at 24 hours after surgery

Secondary Outcome Measures

  1. Postoperative opioid consumption [up to the first 24 hours postoperatively]

    Total amount of morphine consumption during the first 24 hours after surgery. Patient controlled analgesia to be inserted.

  2. Pain intensity score [0, 2, 6, 12, 24 hours postoperatively.]

    Postoperative pain assessed with verbal rating scale (VRS 0: no pain 10:pain as bad as can be ) at 0, 2, 6, 12, 24 hours postoperatively.

  3. Postoperative nausea and vomiting [up to the first 24 hours postoperatively]

    Nausea and vomiting intensity score measured by numeric rank score (0:no nausea and no vomiting, 1: have nausea, no vomiting, 2: once vomiting, 3: two or more vomiting).

  4. Patient satisfaction [at the end of 24 hours postoperatively]

    Patient satisfaction measured using a numeric rating scale 0 to 10 (0 = unsatisfied; 10 =very satisfied)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • ASA I-II-III

  • BMI 20 to 35 kg / m2

  • Patients scheduled for breast cancer surgery procedure

Exclusion Criteria:
  • Patients with previously known allergies to the drugs to be used in the study,

  • Infection near the puncture site,

  • Patients with previous symptoms of neurological disease (TIA, syncope, dementia, etc.)

  • Known coagulation disorders,

  • Alcohol and drug use,

  • Disorder of consciousness,

  • Opioid use equal to or greater than 60 mg oral morphine equivalent per day,

  • Patients with pre-existing neuropathic pain,

  • Liver failure, renal failure, cardiac failure

  • Morbid obesity (body mass index [BMI] > 35 kg m-2)

  • Uncontrolled diabetes mellitus

  • Women during pregnancy or breastfeeding

  • Not approving the informed consent form

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aylin Ceren Şanlı Istanbul Turkey

Sponsors and Collaborators

  • Bezmialem Vakif University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aylin Ceren Sanli, Asist Dr, Bezmialem Vakif University
ClinicalTrials.gov Identifier:
NCT06082141
Other Study ID Numbers:
  • E.116140
First Posted:
Oct 13, 2023
Last Update Posted:
Oct 13, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Aylin Ceren Sanli, Asist Dr, Bezmialem Vakif University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 13, 2023