Health TrialsbyHealthPanel

Erector Spinae Block vs. Placebo Block Study

ConditionsBreast CancerNerve BlockRegional AnesthesiaNeuromuscular Blockade
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorWomen's College Hospital

About this trial

Regional anaesthesia combined with general anaesthesia has become common in the perioperative management of breast cancer surgery patients. Regional techniques have been recognised to provide excellent post-operative analgesia. It enhances multi-modal analgesia regimes while being opioid sparing, reducing incidence of post-operative nausea and vomiting and allowing earlier mobilisation/discharge and improving treatment success. Therefore identifying the correct regional anaesthetic technique for this group of patients is important in providing optimum peri-operative care.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ASA classification: I-III

BMI < 35 kg/m2

Day surgery procedure

Disqualifiers

Prior ipsilateral breast surgery, excluding lumpectomy

Pre-existing neurological deficit or peripheral neuropathy involving the ipsilateral chest

Severe, poorly controlled cardiac conditions, significant arrhythmias, severe valvular heart diseases

Severe, poorly controlled respiratory conditions (severe COPD, severe interstitial lung disease, severe / poorly controlled asthma)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Erector spinae plane block

    Procedure/Surgery

    80mm 22G block needle will be inserted using an in-plane cranial to caudad approach, the needle will be advanced to target the interfascial plane deep to the erector spinae muscle at the T2 transverse process. Once the needle tip is in the correct position, 20 ml of the local anaesthetic (ropivacaine 0.5% with 1:400,000 epinephrine) will be administered slowly in 5 ml aliquots under frequent aspiration and correct spread in the interfascial plane will be observed.

  • Placebo Block

    Procedure/Surgery

    Patients randomised to the Control group will then receive a sham subcutaneous injection of 0.5ml normal saline injected at the same site as the ESP block under ultrasound guidance to stimulate a real block procedure.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Control GroupPlacebo comparator 1 intervention
Group B: Erector spinae plane (ESP) block groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Acute postoperative pain at rest

Following breast surgery, measured as an area under the curve (AUC) of rest pain scores VAS scale where 0 corresponds to no pain, and 10 corresponds to worst pain imaginable

Time frame
24 hours postoperatively
2

Quality of postoperative recovery (QoR 15)

Quality of recovery at 24 hours: questionnaire (0-10, where 0 = none of the time \[poor\] and 10 = all of the time \[excellent\])

Time frame
24 hours post-surgery

Secondary outcomes

1

Postoperative pain scores

VAS scale where 0 corresponds to no pain, and 10 corresponds to worst pain imaginable

Time frame
0, 6, 12, 18, 24 and 48 hours post-operatively
2

Intraoperative opioid consumption

Cumulative oral morphine equivalent after surgery

Time frame
During the procedure
3

Postoperative opioid consumption

Cumulative oral morphine equivalent after surgery

Time frame
12,24,48 hours, 7 days postoperative
4

Duration of phase I (PACU) and phase II (surgical day care, SDC) stay

How fast is the recovery is-expressed in minutes

Time frame
From end of surgical procedure to 24 hours after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Women's College Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: