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Post Operative AnalgesiaPhase 2/3NCT06728514

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

A Phase 2/3 study testing Erector spinae plane block group., Paravertebral Nerve Block and Inj Bupivacaine in people with Post Operative Analgesia and Hemodynamic (MAP) Stability, run by Sahiwal medical college sahiwal at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Erector spinae plane block group., Paravertebral Nerve Block and Inj Bupivacaine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 sitePakistan
Study dates
11 Jan 2024to 9 Aug 2024
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Sahiwal Medical College,Sahiwal

    Sahiwal, Punjab Province, 57000

Other trials in Pakistan

About this study

Official title: 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

Read the 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.

Being tested
Erector spinae plane block group., Paravertebral Nerve Block, Inj Bupivacaine
Keywords
ESPB, PVB, ASA
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Erector spinae plane block group.Procedure or surgery

    Also called ESPB

    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.

  • Paravertebral Nerve BlockProcedure or surgery

    Also called PVB

    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.

  • Inj BupivacaineDrug

    Also called BUPIVACAINE

    Inj Bupivacaine 0.25% (10ml) in both groups

Study groups in NCT06728514
Study groupRoleWhat they receive
GROUP-ESPBExperimentalErector spinae plane block
Receives: Procedure: Erector spinae plane block group.; Drug: Inj Bupivacaine
GROUP-PVBExperimentalPara vertebral block
Receives: Procedure: Paravertebral Nerve Block; Drug: Inj Bupivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Post Op Analgesia

    Duration of post op analgesia.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2024
  2. Study start11 Jan 2024
  3. Primary completion9 Jul 2024
  4. Study completion9 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Group A will receive ESPB and Group B will receive PVB
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06728514
Sponsor's protocol ID
98/IRB
Status last verified
Apr 2026
First submitted
29 Sep 2024
Last updated
4 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Data will be available on request

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Erector spinae plane block group., Paravertebral Nerve Block and Inj Bupivacaine in people with Post Operative Analgesia and Hemodynamic (MAP) Stability, run by Sahiwal medical college sahiwal at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post Op Analgesia (time frame: From performance of block to first rescue analgesia in 24 hours post operatively.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.

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