Local anaesthetic injection below the Erector spinae muscle for pain relief in kidney stone surgery

Not yet recruiting

• Conditions: Calculus of kidney,

• Registration Number: CTRI/2019/12/022428
• Lead Sponsor: M S Ramaiah Medical College

Brief Summary

Percutaneous nephrolithotomy (PCNL), is a minimally invasive procedure,but is associated with substantialpostoperative pain. Ultrasound-guided erector spinae block (ESB) is a popular, interfascialregional technique that was initially described for the management of thoracicneuropathic pain. The erector spinae fascia extends from the nuchal fasciacranially to the sacrum caudally, local anesthetic agents extend throughseveral levels, and the

block can be effective over a large area. The present study isundertaken to ascertain analgesic efficacy of  ultrasound-guided erector spinae block (ESB)in patients undergoing PCNL.

**1.****Aims & Objectives:**

This study aims  to assess the analgesic efficacy of anultrasound-guided ESB versus conventional analgesia for PCNL.

**Primary objective:** Theprimary endpoint is the postoperative pain level based on the visual analoguescale (VAS) scores of patients.

**Secondary objective:** Thesecondary end points is the analgesic consumption and additional analgesiarequirements of the patients in the postoperative period.

 

2. **Hypotheses (if applicable):** ESB mechanism of analgesia is not clear yet but is being used for providing analgesia for various studies. There are no studies on ESB for PCNL surgeries.

3. **Review of literature: (within 500 words):**

i.           Ak K et al.[1] studied 60 patients whounderwent percutaneous nephrolithotomy in a randomized controlled clinicalstudy. Patients were randomly allocated into two groups: group P had 4 ml of0.5% levobupivacaine injected at each of the T10, T11, and T12 paravertebral spacesa standard PVB, and group C received 4 ml of 0.9% NaCl solution. All patientswere given standard general anesthesia. VAS scores and total morphineconsumption were lower in group P than in group C: 2.3 vs. 4.3 and 22.3 vs.43.2 mg, respectively (p < 0.05). The level of satisfaction was higher ingroup P than group C. They concluded that thoracic PVB with levobupivacaineprovided a good postoperative analgesia and increased patient satisfaction forthose who underwent percutaneous nephrolithotomy.

ii.           Saroa R et al.[2] studied 30 patientsundergoing PCNL who were randomized to receive single shot of 20 ml of eitherropivacaine (0.2%) or levobupivacaine (0.2%) in ultrasound-guided paravertebralblock (PVB) using an in-plane technique. They concluded that single-shotultrasound-guided ipsilateral PVB at the end of the surgical procedure providesadequate and effective analgesia in the postoperative period with either of thelocal anesthetic.

iii.           Jonnavithula N et al.[3] studied 60 patientsundergoing PCNL requiring nephrostomy tube who wererandomised to receive either peritubal infiltration or intercostal nerve block(ICNB). At the completion of the procedure, patients in Group P receivedperitubal infiltration and those in Group I received ICNB at 10, 11, 12thspaces using fluoroscopy guidance. Pain scores were lower in the group I at allpoints of measurement than group P. The mean time to first demand for rescue analgesia was higher in Group I (13.22 ± 4.076 h vs7.167 ± 3.92 h *P* - 0.001). The number of demands and the amount ofanalgesics consumed were less in Group I.ICNB provided superior analgesia as evidenced by longer time to first demand ofanalgesic, reduced number of demands and consumption of rescue analgesic.Peritubal infiltration, although less efficacious, may be a safe and simplealternative technique.

iv.           De Cassai A et al.[5] performed aqualitative review of the literature on ESP block. They found that studiesshowed lower use of opioids and a longer time to first analgesic requirement inthe ESP group. In one study, ESP block was found to be as effective as epiduralanalgesia. ESP block has a wide range of clinical indications. Its mechanism ofaction is still not thoroughly understood. Only two reports presentedcomplications caused by the block. They concluded that although data suggeststhat ESP block is an easy and safe technique, more studies are needed to assesssafety, complications rates and efficacy of this technique.

v.           85 publications from 21 journals were includedin the pooled review by Tsui BCH et al [6] which yielded 242reported cases between 2016 and 2018. The majority of publications reportedsingle shot techniques (80.2%), followed by intermittent boluses (12.0%) andcontinuous infusions (7.9%). 90.9% reported use of multimodal analgesia inaddition to the ESPB and 34.7% reported sensory changes from ESPB. A reductionin opioid use was reported in 34.7% of cases. One adverse event involving apneumothorax was reported. This was the first review providing a pooled review ofESPB characteristics. Their conclusion was ESPB appears to be a safe andeffective option for multiple types thoracic, abdominal, and extremitysurgeries.

**4.****Materials  and Methods**

Ø  **Study design :**Prospective clinical pilot study.

Ø  **Study period :**

i) Period which may beneeded for collecting the data       Dec 2019 to June 2020

ii) Period that may berequired for analyzing the data       July 2020 to September 2020

Ø  **Inclusion criteria:**

o   The patients of American Society of Anaesthesiologists (ASA)Grade 1-3 aged between 18-70 years scheduled to undergo PCNL under generalanaesthesia will be included in the study.

o  **Exclusion criteria:**

·        Patients with any history of drug allergy to thestudy drugs,

·        Psychiatric illness, substance abuse,

·        Blood pressure> 140/90mm Hg

·        Pregnancy and lactating mothers

·        Sepsis,

·        Coagulopathy,

·        Complex stones with anticipated access points>2,

·        Patients receiving opioids

·        Any back or musculoskeletal deformity

Ø  **Sample size  withproper justification:** Sample size calculation: In a study by Ak K et al. the VAS scores were found to be 4.3 vs 2.3in the control group and paravertebral group respectively. Settingα = 0.05, assuming a standard deviation of 2 points, and investigating 21subjects for each group, one can detect a significant difference of 2 pointswith a power of 0.9 (two-sided hypothesis). Total of 10 patients will beenrolled in either group for the pilot study.

Ø   **Detailed description of procedure:**                                                                                    Aprospective randomised placebo controlled study will be conducted in 20patients of either sex undergoing PCNL surgeries. Institutional ethicalclearance will be obtained and study will be registered with Clinical TrialsRegistry-India.

Thepatients satisfying the inclusion criteria will be selected from the operationregister on a daily basis. They will be randomised by computer generated randomnumber table and allotted into groups one oftwo groups: group E (ERB) and group C (control) by sealed envelope technique.

**Group E**will receive Erector spinae block postoperatively before extubation

**Group C** willbe the control group who will receive conventional parentral analgesics

Patients will be kept fasting for8 h and premedicated with tablet pantoprazole 40mg on the  night prior to surgery and the morning ofsurgery. In the operation theatre the patients will be connected tomultichannel monitor for electrocardiogram, noninvasive blood pressure,arterial oxygen saturation (SpO2) respiratory rate, and end-tidalcarbon dioxide (EtCO2) monitoring. Standard general anesthetictechnique was used in all patients and maintenance of anesthesia will beachieved through administration of inhalational agent isoflurane with *air* in O2mixture and fentanyl 2mcg/kg will be given for analgesia. If the patient hastachycardia or hypertension (20% over the baseline) Fentanyl 25mcg aliquotswill be administered. The total dose of fentanyl used , duration of surgery andany other intraoperative adverse events will be noted. Group C patients will beturned supine at the end of surgery and extubated.

At the end of surgery as all PCNLsare performed in prone position, unilateral ESB on the side of surgery will beperformed at T10-11in group E patients level before turning them supine forextubation. Ensuring complete asepsis, ESB will be performed using 5–12 MHzlinear array ultrasound transducer probe will be placed 2–3 cm laterally fromthe midline. After the identification of the T10 transverse process andoverlying erector spinae muscles. The needle will be inserted using thein-plane technique following the same injection point in the cranial to caudaldirection until the tip contacted to the T10 transverse process. When thecorrect needle tip position is confirmed by hydro-location with 1 ml ofisotonic saline solution aliquots, the anesthesiologist will inject 25ml of0.5% ropivacaine deep to the erector spinae muscle after negative aspirationthrough 22 G × 100 mm needle (Stim Sonoplex, Pajunk, Germany). Thereafter thepatient will be made supine, extubated after adequate reversal, and transferredto post anesthesia care unit (PACU). The anesthesiologist performing the blockand subsequently the investigator assessing the block will be blinded to thegroup allocation.

The patients will be observed inPACU for heart rate, hemodynamic parameters (systolic and diastolic bloodpressure), SpO2, and respiratory rate at regular intervals for onehour. Pain scores at rest and cough will be evaluated using VAS for pain (0 cm= no pain; 10 cm = worst pain imaginable). The patients will then be transferredto ward if there were no complaints and VAS is <4. The patients will beassessed at 30 minutes, 1, 2,4, 8, 12, 24, 48 and 72 hours for all theparameters, including VAS.

Postoperatively analgesis will beadministered to patients with intravenous paracetamol infusion over 20 min(1000 mg) if VAS exceeds 4 and parcetamol will then be repeated every 6 hours. IfVAS is >4; 30 minutes after paracetamol infusion injection tramadol 50 mgwill be administered intramuscularly. Total dosages of the analgesics will berecorded, calculated, and compared in both the groups at the end of 24, 48& 72h. Patient satisfaction data will be evaluated using a 5-point scale(1: very bad; 2: bad; 3: good; 4: very good; 5: perfect).In addition, all thepatients were monitored for the complications of either the procedure(pneumothorax, accidental epidural) or drugs (bradycardia, hypotension) duringthe entire postoperative period.

Ø  **Potential risks and benefits:** Better patient comfortand postoperative analgesia.

Ø  **Place of the study:** Ramaiah Medical College and Hospitals, Bangalore

Ø  **Biologicalmaterials required (type - blood, tissue etc and quantity) :** none

Ø  **Investigations:** Routine investigations for the surgical procedureas per American society of Anaesthesiologists physical status classificationwill be prescribed. No additional investigations required.

Ø  **Outcome measures:** The patients will be instructed on the VAS, where0 defines “no pain†and 10 defines “the worst pain he or she had everexperienced.†The pain level will be followed up with VAS, and the analgesicconsumption will recorded during the postoperative 24 hours by a researcher whowas not a member of the surgical team (at the30 minutes, 1, 2,4, 8, 12,and 24 h)

Ø  **Statistical methods :** Age, height, weight, duration of theoperation, VAS scores, and analgesic consumption will be analyzed by using ANOVA.The χ2 test will used to compare adverse events, additionalanalgesic requirement and patient satisfaction. A p value <0.05 will beconsidered significant.

5.     Ethical considerations and methods toaddress issues: Informed written consentwill be obtained from patients included in the study.6.     Implications of the study: New technique for postoperative analgesiafollowing PCNL. 8.     References

1. Ak K, Gursoy S, Duger C, Isbir AC, Kaygusuz K, Ozdemir Kol I, Gokce G, Mimaroglu C. Thoracic paravertebral block for postoperative pain management in percutaneous nephrolithotomy patients: a randomized controlled clinical trial. *Med Princ Pract*. 2013 Mar;22(3):229-33. doi: 10.1159/000345381. Epub 2012 Dec 14. PubMed PMID: 23257888; PubMed Central PMCID: PMC5586743.

2. Saroa R, Palta S, Puri S, Kaur R, Bhalla V, Goel A. Comparative evaluation of ropivacaine and levobupivacaine for postoperative analgesia after ultrasound-guided paravertebral block in patients undergoing percutaneous nephrolithotomy. J Anaesthesiol Clin Pharmacol. 2018 Jul-Sep;34(3):347-351. doi: 10.4103/joacp.JOACP\_187\_17. PubMed PMID: 30386018; PubMed Central PMCID: PMC6194850.

3. Jonnavithula N, Chirra RR, Pasupuleti SL, Devraj R, Sriramoju V, Pisapati MV. A comparison of the efficacy of intercostal nerve block and peritubal infiltration of ropivacaine for post-operative analgesia following percutaneous nephrolithotomy: A prospective randomised double-blind study. *Indian J Anaesth*. 2017 Aug;61(8):655-660. doi: 10.4103/ija.IJA\_88\_17. PubMed PMID: 28890561; PubMed Central PMCID: PMC5579856.

4. Bang S. Erector spinae plane block: an innovation or a delusion? *Korean J Anesthesiol*. 2019 Feb;72(1):1-3. doi: 10.4097/kja.d.18.00359. Epub 2019 Jan 31. PubMed PMID: 30732436; PubMed Central PMCID: PMC6369339.

5. De Cassai A, Bonvicini D, Correale C, Sandei L, Tulgar S, Tonetti T. Erector spinae plane block: a systematic qualitative review. Minerva Anestesiol 2019;85:308-19. DOI: 10.23736/S0375-9393.18.13341-4.

6. Tsui BC, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth 2018; 53: 29-34.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-12-17
• Study Start: 2019-12-24

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Patients aged between 18-70 years Patients scheduled to undergo Percutaneous Nephrolithotomy (PCNL) under general anaesthesia ASA (American Society of Anesthesiology) Physical status I to III patients.

Exclusion Criteria

Patients with any history of drug allergy to the study drugs, Psychiatric illness, substance abuse, Blood pressure> 140/90mm Hg Pregnancy and lactating mothers Sepsis Coagulopathy Complex stones with anticipated access points >2, Patients receiving opioids Any back or musculoskeletal deformity.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the postoperative pain level based on the visual analogue scale (VAS) scores of patients.	Immediate post operative period (0 hour) | Then at 1st, 2nd, 4th, 6th, 12th, 18th, 24th, 48 and 72 | hours after surgery

Secondary Outcome Measures

Name	Time	Method
The secondary end points is the analgesic consumption and additional analgesia requirements of the patients in the postoperative period	Immediate post operative period (0 hour)

Trial Locations

Locations (1)

M S Ramaiah medical college & Hospitals; 🇮🇳 Bangalore, KARNATAKA, India

M S Ramaiah medical college & Hospitals

🇮🇳Bangalore, KARNATAKA, India

Dr Vinayak P S

Principal investigator

9900859460

drvinayak@outlook.com