Study of Continuous Erector spinae plane block for pain relief in breast cancer surgery patients

Completed

Conditions: Malignant neoplasm of overlappingsites of breast,

Registration Number: CTRI/2021/03/032366

Lead Sponsor: Dr Shalini Bajpai

Brief Summary: **Background:** In India, one of the most common cancers among women is carcinoma breast (25%â€“32%).   Multimodal analgesia is standard of care for pain relief in breast cancer surgeries . Conventionally, General Anaesthesia is used in breast surgeries in which opioids are commonly used for pain relief. When given in the immediate post operative period after general anaesthesia, side effects like nausea, vomiting, pruritus, constipation, drowsiness, respiratory depression may occur because of opioids use in first 24 hrs post surgery. Regional anaesthetic techniques used for breast surgery have shown reduced opioid requirements along with providing good pain relief, reduced postoperative nausea/vomiting (PONV), reduced incidence of chronic pain, and early rehabilitation. The erector spinae plane (ESP) block is a novel regional anesthesia technique for thoracic surgery analgesia and neuropathic pain . It an interfascial block which provides multidermatomal analgesia due to its extensive craniocaudal spread by blocking the dorsal and ventral rami of spinal nerves. Its advantage over other RA techniques includes easy technique, performed away from pleura and neuraxis avoiding any complications, less time consuming, easy catheter insertion, and broad coverage .Though recent studies of ESP have shown significant reduction in opioid consumption, good post operative analgesia but the results about duration of ESP block has been equivocal. Considering the limited duration of single shot ESP block, opioids are again required in late post operative period for pain relief. To overcome the limited duration of ESP block, a Continuous ESP block (continuous infusion of local anaesthetic in ESP block) can be given to provide sustained pain relief. We propose that a Continuous Erector spinae plane block will provide effective analgesia in early as well as late postoperative period and maintaining the catheter for 24 hrs post surgery will be advantageous in providing sustained pain relief and reduce opioid requirements to minimum. The purpose of this study is to evaluate the analgesic efficacy and opioid sparing effect of US-guided continuous ESP block in patients undergoing elective breast cancer surgery.

**AIMS AND OBJECTIVES**

**Primary objective**

To compare total postoperative opioid (Tramadol) consumption in 24 hours post surgery.

**Secondary objectives:** To compare the following between two groups

Â·         Pain scores (NRS 0-10) in 24 hrs post surgery.

Â· Incidence of Post operative nausea and vomiting in 24 hrs post surgery

Â·         Intra operative opioid ( fentanyl )consumption

Â·         Patient satisfaction score at discharge.

**MATERIALS AND METHODS**

**Study design**: Single centre, prospective, randomized controlled study to be undertaken after ethical committee approval at  Homi Bhabha cancer Hospital and Research Centre, Visakhapatnam (A.P)

**Study procedure:** On day of surgery, all patients fulfilling inclusion criteria will be will be randomly assigned to either Group B (Block group) or Group C (Control group) as per computer generated random allocation table. Patients in group B will receive USG guided Continuous ESP block while patients in group C will not receive any intervention. Both group patients will receive general anaesthesia similarly as per standard protocol.

**Continuous ESP block technique:** All patients in group B will be given Continuous ESP block in the preoperative block area, using 6-13 MHz linear array ultrasound transducer placed at T3 level in craniocaudal direction , 3cm away from midline to identify the T3 transverse process and overlying Erector spinae muscle . A 18G Tuohy needle will be introduced in a cranio caudal direction, using in plane technique and navigated to touch the transverse process underneath the erector spinae muscle and 25 ml of 0.25% Bupivacaine will be injected in interfacial plane deep to erector spinae muscle . It will be followed by threading a 18 G multiport epidural catheter through the needle caudally,   atleast 5cm beyond the needle tip, deep to Erector spinae muscle plane . All group B patients will be then taken to operation theatre and General Anaesthesia will be given as per standard protocol described below. Continuous ESP infusion of 0.1% Bupivacaine at 5 ml/hr will be started through the catheter towards the end of surgery, and will be continued in post operative period for 24 hours using elastomeric infuser.

**General Anaesthesia procedure**: General anaesthesia will be given similarly to all patients of group B (after ESP block) and group C as per standard protocol. After premedication with Inj Midazolam 0.03 mg/kg , all patients will be induced with Inj. Propofol 2-2.5 mg/kg, Inj. Fentanyl 2mcg/kg and muscle relaxant Inj. Vecuronium 0.1mg/kg I.V. An appropriate size endotracheal tube (ETT) / supraglottic device (SGA) will be placed. Maintainence will be with sevoflurane 2 %, 66% N2O in oxygen and intermittent positive pressure ventilation . Bolus of Inj. Fentanyl 0.5mcg/kg I.V will be administered to treat rise in heart rate / blood pressure (2 consecutive readings of 20% above baseline). Total intra operative fentanyl consumption will be recorded. Towards the end of surgery, Inj. Paracetamol 1gm and Inj Ondansetron 8mg I.V will be given for pain relief and PONV prevention respectively. Neuromuscular blockade will be reversed Inj. Neostigmine 0.05mg/kg and Inj. Glycopyrrolate 0.01mg/kg I.V, ETT/SGA removed and patient will be shifted to post anaesthesia care unit (PACU).

All patients will be monitored in post operative period and postoperative analgesia will be provided with Inj Paracetamol 1gm every 8 hr IV. Pain score will be evaluated by means of a Numerical rating scale (NRS) and recorded at the time of arrival in PACU at 0 hr and then at 1,2, 6, 12, and 24 h after surgery.   Rescue analgesia will be given with intravenous Inj.Tramadol 1mg/kg if NRS â‰¥4 or patient demands analgesic medication (within 8 hr of giving due dose of Inj Paracetamol 1gm IV). Total Tramadol consumption in 24 hours post surgery will be recorded. Incidence of nausea and vomiting in post operative period will be recorded and managed by Inj Ondansetron 8 mg IV. Patient satisfaction score will be recorded at discharge by 5 point Likert scale (5-Very satisfied, 4- Relatively satisfied, 3- Neutral, 2-Relatively dissatisfied, 1- Very dissatisfied)

**Statistics:**

**Sample size estimation**: To detect a 50% difference in postoperative opioid requirements at 24 hr using ESP compared to the control group (GA) for 90% power and an alpha error of 0.01, sample size calculated as 21 subjects for each group. We intend to include 25 patients in each group for securing patient dropouts, thus making sample size 50. [Mean+SD of control group for sample size calculation is taken from referral study by Gurkan et al ]

**Statistical analysis:**Descriptive statistics will be performed with SPSS software, version 26.0. Qualitative variables will be expressed as numbers and percentage and quantitative variables as means, standard deviation, medians, IQR as appropriate

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 50

Inclusion Criteria

American Society of Anesthesiologists (ASA) physical status Iâ€“II Elective surgery for breast cancer.
Unilateral surgical procedures [ MRM (Modified radical mastectomy) , BCS ( Breast conservation surgery)].

Exclusion Criteria

BMI (body mass index ) > 35 kg/m2 Infection of the skin at the site of the needle puncture Known allergies to Local Anaesthetics Mastectomy with simultaneous reconstructive surgery using a muscle flap or implant Coagulopathies Chronic use of opioid drugs.
Psychosis Refusal to give consent Pregnant and Lactating women.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total postoperative opioid (Tramadol)consumption	In 24 hours post surgery

Secondary Outcome Measures

Name	Time	Method
Pain score (Numeric pain rating scale 0 to 10)	0,1,2,6,12,24 hours post surgery
Intra operative opioid (fentanyl) consumption	from induction of anaesthesia to reversal of neuromuscular blockade
Patient satisfaction score	At discharge
Incidence of PONV( post operative nausea and vomiting	24 hours post surgery

Trial Locations

Locations (1): Homi Bhabha cancer hospital and research centre
🇮🇳
Visakhapatnam, ANDHRA PRADESH, India
Homi Bhabha cancer hospital and research centre
🇮🇳Visakhapatnam, ANDHRA PRADESH, India
Dr Shalini Bajpai
Principal investigator
9666429374
shln.bajpai@gmail.com