The Comparison Of Two Fascial Plane Blocks For Post Operative Analgesia In Abdominal Surgeries.

Not yet recruiting

• Conditions: Other specified diseases of intestine,

• Registration Number: CTRI/2022/02/040346
• Lead Sponsor: Himalayan Institute Of Medical Sciences

Brief Summary

TheInternational Association for the Study of Pain (IASP) defines pain as “anunpleasant sensory and emotional experience associated with actual or potentialtissue damage, or described in terms of such damageâ€.

Post-operativepain is a problem for many patients and affects recovery, risk ofpost-operative complications and quality of life. A thorough preoperativeevaluation, careful perioperative planning, identification, and individualizedtreatment of high-risk patients can reduce post-operative pain. Multimodaltreatment combines different analgesic techniques in order to utilizesynergistic and additive effects of different treatments and has the potentialto optimize effects and reduce side effects.

Currently,various modalities for post-operative pain management exist. Traditionallyopioids ,NSAIDS and Paracetamol were used as the main agents for post-operativeanalgesia.Newer modalities include Patient Control Analgesia (PCA) pumps, epidural neuraxial blocks and peripheral nerve blocks.With multimodal approach there is decrease in opioid requirement and at thesame time reduction in side effects due to opioids such as nausea, vomiting,drowsiness and constipation.

There is anincreasing trend toward the use of peripheral nerve blocks for post-operativepain control. They are one of the safest and most effective methods to controlpain from surgery.For post- operative pain control nerve blocks can begiven alone or as a component of multimodal analgesia. In a peripheral nerveblock, anaesthetic drug is injected at a particular site around the nerveswhich then stop the pain signal to reach the brain, thus provides analgesia.Peripheral nerve block can be given as a single injection (sPNB), whenpost-operative pain is of short duration or as a continuous catheter infusion(cPNB), when prolonged post-operative analgesia is required .

Uncontrolledpain after abdominal surgery increases the incidence of postoperativecomplications, as it prolongs hospitalization, and increases health care costsand the use of opioids.Interfacial plane blocks suchas Quadratus Lumborum block (QLB) and Errector Spinae block are the newemerging modalities, performed by ultrasound guidance, that are being put touse for post operative analgesia in patients undergoing abdominal surgeries.

Quadratuslumborum block has been used for postoperative analgesia in patients undergoingupper abdominal surgeries. The analgesia is achieved in T7–L1 dermatomes,with cranialspread to T4–T5 and caudal spread to L2–L3 dermatomes. Quadratus lumborum block 3 implies the application of thelocal anesthetic between the QLM and the psoas major muscle (PMM) at the frontof the QLM, at the level of its attachment to the transverse process of L4vertebra.

Erector spinae block (ESB) is an interfascialplane block in which anaesthetic drug is injected between anterior surface ofErector spinae muscle and transverse process of underlying vertebra. It actsby blocking dorsal and ventral rami of spinal nerves .Block will be performedat the T9 level in our study.

Ropivacaine is along-acting amide local anaesthetic agent and first produced as a pureenantiomer .It produces effects similar to other local anaesthetics viareversible inhibition of sodium ion influx in nerve fibres. Ropivacaine is lesslipophilic than bupivacaine and is less likely to penetrate large myelinatedmotor fibres, resulting in a relatively reduced motor blockade.Thus,ropivacaine has a greater degree of motor sensory differentiation, which couldbe useful when motor blockade is undesirable. The reduced lipophilicity is alsoassociated with decreased potential for central nervous system toxicity andcardiotoxicity.

Patient controlled analgesia (PCA) is anothermodality which is given along with   peripheral nerve blocks to reduce post-operative pain. PCA allow patientto control his desired level of analgesia which ultimately lead to patientsatisfaction .

The above mentioned nerve blocks have beenstudied and used in the management of postoperative pain in patients undergoingupper abdominal surgeries with variable results. So, in this study we will becomparing the effectiveness of Quadratus lumborum block and Erector spinaeplane block along with PCA for post-operative pain management in abdominalsurgeries with midline incision.

**SampleSize:**

n= (Z2a/2p(1-p)

d2

Z α/2 = 1.96 at 5% level of significance

p = prevalence

Here, we conside p=50%

p=505=0.5

1-p=1-0.5=0.5

d=adsolute pricisim

d=12%=0.12

n= (1.96)2x(0.5)x(0.5)

(0.12)2

n= 3.84x0.25

0.0144

n=66.66

n = 67

So, the sample size is 67.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-02-15
• Study Start: 2022-02-16

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Not specified
• Target Recruitment: 67

Inclusion Criteria

18-65 Years 2)Gender– Both male and female patient 3)Physical Status :American Society of Anesthesiologists (ASA) I and II patients scheduled to undergo upper abdominal surgeries with midline incision.

Exclusion Criteria

1)American Society of Anaesthesiologists(ASA) physical status more than or equal to III patients 2)Local infection at the site of block 3)H/o allergy to study medications 4)Patients on chronic pain relief medications 5)Allergic to local anesthetics 6)Bleeding disorders 7)Dyselectrolytemias 8)Patient on anti-coagulants 9)Inability to give informed consent 10)Severe cardiovascular , respiratory, liver and kidney disease 11)Patient who cannot operate Patient Controlled Analgesia (PCA) system 12)Psychiatric disorders.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To observe and evaluate post operative analgesic efficacy of ultrasound guided Bilateral Quadratus Lumborum block and Bilateral Erector Spinae block in abdominal surgeries with midline incision.	To observe the total post operative fentanyl consumption over 24 hrs after administration of each block in either group and to study pain intensity at 0,4,8,12,16,20 and 24 hrs intervals respectively.

Secondary Outcome Measures

Name	Time	Method
The secondary outcome variable will be Motor block.It will be evaluated using modified Bromage Score.	It will be calculated at time points 0,4,8,12,16,20 and 24 h after anesthesia recovery.

Trial Locations

Locations (1)

Himalayan Institute Of Medical Sciences; 🇮🇳 Dehradun, UTTARANCHAL, India

Himalayan Institute Of Medical Sciences

🇮🇳Dehradun, UTTARANCHAL, India

Dr Manjot Kaur Ahluwalia

Principal investigator

8437973351

manjotkaur0194@gmail.com