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Clinical Trials/NCT06936852
NCT06936852CompletedNot Applicable

Ultrasound Guided Serratus Posterior Superior Intercostal Plane Block Versus Pectoral Nerve (PECS II) Block For Pain Control In Breast Surgeries: A Randomized Comparative Trial

Tanta University1 site in 1 country100 target enrollmentStarted: February 27, 2025Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Locations
1
Primary Endpoint
Bedside forced vital capacity at 2 hours after surgery

Study Overview

Brief Summary

The aim of the study is to compare the analgesic effect of ultrasound guided serratus posterior superior intercostal plane (SPSIP) block and pectoral nerve (PECS II) block in different breast surgeries.

Detailed Description

All patients will be seen in the anesthesia clinic, optimization of general condition and all required investigations will be done before surgery. Patients will be premedicated with 1.5 mg midazolam and 4 mg granisetron. Standard basic monitoring will be applied to all patients then after adequate preoxygenation, induction of general anesthesia will be done through wide bore cannula using 1 mic/kg fentanyl, 1-2 mg/kg titration of propofol, 0.5mg/kg atracurium. Patients were mechanically ventilated using volume-controlled ventilation (VCV) with adjustment of end tidal carbon dioxide (ETCO2) to be 32-35 mmHg, 50% inspired oxygen in air and sevoflurane concentration to be 1MAC. The patients will receive either block before skin incision that will be done 20 minutes after the block. 0.5 mic/kg fentanyl will be injected when heart rate or blood pressure increases more than 20% of baseline. By the end of the surgery, 1gm paracetamol will be administered with fully reversal of muscle relaxants at the end of the surgery.

SPSIP group After induction of anesthesia, patients will be placed in lateral decubitus position, the affected arm will be adducted and medially rotated. Under complete aseptic technique, a high frequency linear probe will be placed adjacent to upper medial part of scapula to visualize the second and third ribs. The structures from superficial to deep are skin, subcutaneous, trapezius, rhomboid, serratus posterior superior and intercostal muscles. The needle will be introduced with in plane approach, from caudal to cranial and 30 ml of 0.25% bupivacaine will be injected in the fascial plane between serratus posterior superior and intercostal muscles at the level of second and third ribs.

PECS II group With the patient in supine position, the ipsilateral upper arm will be abducted and externally rotated. Under complete aseptic technique, a high frequency linear probe will be placed in the infraclavicular region, angulated and directed laterally towards the axilla to visualize the third and fourth ribs with pectoralis major, minor and serratus anterior muscles from superficial to deep. The needle will be introduced with in plane approach from medial to lateral, 10 ml of 0.25% bupivacaine will be injected in the fascial plane between pectoralis major and pectoralis minor then the needle will be further introduced to the fascial plane between pectoralis minor and serratus anterior muscles with injection of 20 ml of 0.25% bupivacaine.

After extubation, the patients will be transferred to PACU (Post-Anesthesia Care Unit) for monitoring. Numerical rating scale (NRS) will be used for pain assessment while 0 is no pain and 10 is severe agonizing pain. Patients will be given a rescue analgesia of 0.05 mg / kg morphine if NRS ≥ 4 and repeated if needed. Intravenous 1 gm paracetamol every 8 h and 30 mg ketorolac (if not contraindicated) every 12 h will be given regularly.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Masking Description

double blinded study

Eligibility Criteria

Ages
21 Years to 70 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Age from 21 to 70 years.
  • American Society of Anesthesiologists (ASA) Physical Status Classification System I-II.

Exclusion Criteria

  • Any patient refuses to participate.
  • Bleeding or coagulation disorders, hepatic dysfunction, psychiatric diseases.
  • Chronic opioid use.
  • Patients with pulmonary diseases.
  • History of allergy to local anesthetics.
  • Infection at the needle entry point will be excluded.

Arms & Interventions

SPSIP Group

Active Comparator

Under complete aseptic technique, a high frequency linear probe will be placed adjacent to upper medial part of scapula to visualize the second and third ribs. The needle will be introduced with in plane approach, from caudal to cranial and 30 ml of 0.25% bupivacaine will be injected in the fascial plane between serratus posterior superior and intercostal muscles at the level of second and third ribs.

Intervention: Serratus posterior superior intercostal plane block (Procedure)

PECS II group

Active Comparator

Under complete aseptic technique, a high frequency linear probe will be placed in the infraclavicular region, angulated and directed laterally towards the axilla to visualize the third and fourth ribs with pectoralis major, minor and serratus anterior muscles from superficial to deep. The needle will be introduced with in plane approach from medial to lateral, 10 ml of 0.25% bupivacaine will be injected in the fascial plane between pectoralis major and pectoralis minor then the needle will be further introduced to the fascial plane between pectoralis minor and serratus anterior muscles with injection of 20 ml of 0.25% bupivacaine.

Intervention: PECS II block (Procedure)

Outcomes

Primary Outcomes

Bedside forced vital capacity at 2 hours after surgery

Time Frame: Two hours after surgery

Three measurements were taken and the highest one was recorded

Total morphine consumption

Time Frame: first postoperative 24 hour

Total morphine consumption in first postoperative twenty four hour

Secondary Outcomes

  • NRS pain scores for breast when reaching recovery room arrival, after 2 hour, 6 hour, 12 hour, 18 hour, 24 hour at rest and during arm movement(when reaching recovery room (average 10 minutes after surgery), after two, six, twelve, eighteen, twenty four hour)
  • Time to first rescue opioid dose(24 hours after surgery)
  • Incidence of chronic pain at 3 and 6 months after surgery(6 months after surgery)
  • Block related complications and side effects(24 hours after surgery)
  • Axilla NRS pain scores evaluated at the same time points of that for breast pain(24 hours after surgery)
  • Bedside forced vital capacity at 6 and 24 hours after surgery(24 hours after surgery)
  • NRS when reaching recovery room arrival, after 2 hour, 6 hour, 12 hour, 18 hour, 24 hour(when reaching recovery room (average 10 minutes after surgery), after two, six, twelve, eighteen, twenty four hour)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ahmed Abdel Wahed Ali

lecturer at Anesthesia & Surgical ICU and Pain Medicine

Tanta University

Study Sites (1)

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