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

April 28, 2026 updated by: Dr. Mujahid jamil, Sahiwal medical college sahiwal

Comparative Study of Ultrasound Guided Erector Spinae Plane Block vs Ultrasound Guided Paravertebral Block For Post-oprative Analgesia In Patient's After Open Renal Surgeries

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After identifying eligible patients, written consent will be taken from them patients will be counselled about Numeric Rating Scale (NRS) scoring system. A score of 0 will be considered no pain, a score of 1-3 will be considered mild pain, 3-6 will be considered moderate pain and 7-10 as severe pain. Participants will be randomized in a parallel design with a computer-generated assignment to either local anaesthetic ESPB (Group A) or PVB (Group B) in a 1:1 ratio. In pre OP room intravenous access will be obtained and a monitor will be attached and baseline vitals will be measured i.e, blood pressure, heart rate, oxygen saturation, respiratory rate and temperature.Patients will be operated under General anaesthesia monitor will be attached to measure blood pressure, heart rate respiratory rate, oxygen saturation and ECG. Induction will be done with inj. Propofol 2mg/kg, inj. Atracurium 0.5mg/kg; ETT with cuff will be passed and fixed. Inj. Nalbuphine 0.1mg/kg and inj. Paracetamol 10mg/kg will be given for analgesia. Anaesthesia will be maintained by 50:50 mixture of oxygen and nitrous oxide as well as 1-1.5 MAC of Isoflurane and inj. Atracurium 0.1mg/kg boluses on requirement. At the end of the surgical procedures on OT table USG ESPB or PVB will be perfomed.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 drug injected in this plane spreads in the longitudinal axis to both cephalad and caudal direction over several levels as the erector spinae fascia extends from nuchal fascia to the sacrum. 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.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. The needle insertion point will be marked approximately 2.5-3 cm lateral from the midline. At these points, 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. The depth of the PVS has been estimated at 3 to 6 cm from the skin surface. 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 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. Time taken to perform block in minutes will be noted from placing transducer to taking out needle after injecting drug in plane.All the patients will recover from general anaesthesia, inj. Neopyrolate 0.05mg/kg will be given as reversal. Awake extubation will be done. After recovery pain will be assessed at 4, 8, 12 and 24 hours as primary outcome. Postoperative pain will be assessed using NRS ranging from 0 to 10, on which 0 means no pain and 10 will show worst pain. A higher score will indicate the worst outcome. A score of 0 will be taken as no pain, a score of 1-3 will be considered mild pain, 3-6 will be considered moderate pain, and 7-10 as severe pain. The nurse will assess the outcome, and both the nurse and patients will be blind and unaware about the group they will in to prevent any bias in the study. Secondary outcomes will include, ease of performance, rescue analgesia time and opiod sparing effect.

For pain-relief medications, inj. Tramadol 1mg/kg will be given to the patient when NRS score is 4 or more. For bradycardia inj. Atropine 0.01mg/kg will be given. For nausea complain, ondansetron will be administered with the first dose of 4 mg followed by 1 mg if required. No prophylactic antiemetics will be administered.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Sahiwal, Punjab Province, Pakistan, 57000
        • Sahiwal Medical College,Sahiwal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GROUP-ESPB
Erector spinae plane block
Procedure: Erector spinae plane block group.
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.
Other Names:
  • ESPB
Drug: Inj Bupivacaine
Inj Bupivacaine 0.25% (10ml) in both groups
Other Names:
  • BUPIVACAINE
Experimental: GROUP-PVB
Para vertebral block
Drug: Inj Bupivacaine
Inj Bupivacaine 0.25% (10ml) in both groups
Other Names:
  • BUPIVACAINE
Procedure: Paravertebral Nerve Block
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.
Other Names:
  • PVB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post Op Analgesia
Time Frame: From performance of block to first rescue analgesia in 24 hours post operatively.
Duration of post op analgesia.
From performance of block to first rescue analgesia in 24 hours post operatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahiwal medical college sahiwal

Collaborators

Department of medical education

Investigators

  • Study Director: Adeel Riaz, MD, Sahiwal Teaching Hospital, Sahiwal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2024

Primary Completion (Actual)

July 9, 2024

Study Completion (Actual)

August 9, 2024

Study Registration Dates

First Submitted

September 29, 2024

First Submitted That Met QC Criteria

December 7, 2024

First Posted (Actual)

December 11, 2024

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 98/IRB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be available on request

IPD Sharing Time Frame

August 2024

IPD Sharing Access Criteria

On Demand

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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