Comparative Study of USG Guided ESPB vs USG Guided PVB For Post-op Analgesia In Patient's After Open Renal Surgeries

NCT06728514 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 98/IRB
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Pain control following open renal surgeries are of utmost importance in order to reduce the chance of chronic pain development, and facilitate early rehabilitation. The erector spinae plane block (ESPB) is a recently developed regional anaesthesia procedure successfully used for different types of surgical procedures including open renal surgeries. A Comparative cross-sectional study design will be used and patients fulfilling the inclusion criteria will be included that are admitted through the Outpatient department. Patients will be optimized for surgery. A detailed history will be taken regarding the mode of injury, any preexisting disease and previous surgery and finally thorough examination of the patient will be done to rule out any systemic disease. Informed consent will be taken. These patients will be divided into 2 groups by simple lottery method in group A and B.All the data collected will be entered and analyzed by SPSS version 25.0. Age, surgery d.uration, intraoperative heart rate, intraoperative MAP, total postoperative opioid consumption, total intraoperative opiod and isoflurane consumption, time to first required analgesic, and VAS during the first postoperative 24 h will be summarized, according to normality, into mean (± standard deviation \[SD\]) or median (range). According to data normality, the hypothesis of significant differences between the two studied groups will be challenged using the one-way analysis of variance (with least significant difference correction) or Kruskal-Wallis tests (VAS). Moreover, a p value of \< 0.05 will be regarded to be statistically significant

Conditions

Post Operative Analgesia; Hemodynamic (MAP) Stability; Renal Surgeries; Hypertension

Keywords

ESPB; PVB; ASA

Outcome Measures

Primary Outcomes (1)

• Post Op Analgesia

  Duration of post op analgesia.

  From performance of block to first rescue analgesia in 24 hours post operatively.

Study Arms (2)

GROUP-ESPB

EXPERIMENTAL

Erector spinae plane block

Procedure: Erector spinae plane block group.; Drug: Inj Bupivacaine

GROUP-PVB

EXPERIMENTAL

Para vertebral block

Procedure: Paravertebral Nerve Block; Drug: Inj Bupivacaine

Interventions

Erector spinae plane block group. PROCEDURE

In ESPB technique the linear transducer will be placed over the spinous process of the vertebra and a point 3 cm lateral to it are marked at the T10-T11 level before performing the block. Under aseptic precautions, the 23G spinal needle is inserted and advanced perpendicular to the skin in all planes to contact the transverse process of the vertebra. The transverse process of the thoracic vertebra lies at a variable depth of 2-4 cm from the skin depending on the build of the individual. At this point, the needle tip lies between the erector spinae muscle and transverse process. After negative aspiration, local anesthetic is injected in 3-5 ml aliquots. A volume of 20-25 ml of 0.25% bupivacaine will be used for analgesia on each side depending upon the surgery and requirements. The number of attempts will be noted.Time taken to perform block in minutes will be noted from placing transducer to taking out needle after injecting drug in plane.

Also known as: ESPB

GROUP-ESPB

Paravertebral Nerve Block PROCEDURE

In PVB technique the patient will be placed in the lateral position, and the superior aspect of the T9,T10 and T11 spinous processes will be identified. Under complete aseptic precautions and after skin infiltration with LA, 23G spinal needle will be inserted perpendicular to the skin, with the goal of contacting the tranverse process. Once the TP is contacted, generally at a depth of 2 to 5 cm in adults, the needle is withdrawn into the subcutaneous tissue, redirected in a caudal direction, and then slowly advanced with the purpose of entering the PVS at an approximate depth of 1.0 to 1.5 cm past the initial contact with the TP. After perforating the costotransverse ligament and negative aspiration for blood, air, or spinal fluid,10 mL of 0.25% bupivacaine will be injected at each level superficial to to the pleural line. Displacement of the pleura line anteriorly will be confirmed proper injection of the local anaesthetic solution. The number of attempts will be noted.

Also known as: PVB

GROUP-PVB

Inj Bupivacaine DRUG

Inj Bupivacaine 0.25% (10ml) in both groups

Also known as: BUPIVACAINE

GROUP-ESPB; GROUP-PVB

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Both Genders
• Age between 18 years to 60 years.
• BMI ≤ 30 kg/m2
• ASA I or ASA II

You may not qualify if:

• Patients who do not give consent.
• Relevant drug allergy.
• Pregnancy
• Alcohol or drug abuse.
• Infection at the site of injection.
• Taking of pain medications within 24 h before surgery.
• Chronic hepatic or renal failure.
• Deranged coagulation profile

Sponsors & Collaborators

• Sahiwal medical college sahiwal: lead
• Department of medical education: collaborator

Study Sites (1)

Sahiwal Medical College,Sahiwal

Sahiwal, Punjab Province, 57000, Pakistan

Location

MeSH Terms

Conditions

Hypertension

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Adeel Riaz, MD

  Sahiwal Teaching Hospital, Sahiwal

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Anaesthesiology

Model Details: Group A will receive ESPB and Group B will receive PVB

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: December 11, 2024
• Study Start: January 11, 2024
• Primary Completion: July 9, 2024
• Study Completion: August 9, 2024
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: August 2024
• Access Criteria: On Demand

Locations

PA (1)