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

NCT ID: NCT06728514

Last Updated: 2024-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-11
• Study Completion Date: 2024-08-09

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

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.

Conditions

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

Keywords

ESPB; PVB; ASA

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

GROUP-ESPB

Erector spinae plane block

Group Type: EXPERIMENTAL

Erector spinae plane block group.

Intervention Type: 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.

Inj Bupivacaine

Intervention Type: DRUG

Inj Bupivacaine 0.25% (10ml) in both groups

GROUP-PVB

Para vertebral block

Group Type: EXPERIMENTAL

Paravertebral Nerve Block

Intervention Type: 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.

Inj Bupivacaine

Intervention Type: DRUG

Inj Bupivacaine 0.25% (10ml) in both groups

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Inj Bupivacaine

Inj Bupivacaine 0.25% (10ml) in both groups

Intervention Type: DRUG

Other Intervention Names

ESPB; PVB; BUPIVACAINE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Department of medical education

UNKNOWN

Sponsor Role: collaborator

Sahiwal medical college sahiwal

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Mujahid jamil

Resident Anaesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adeel Riaz, MD

Role: STUDY_DIRECTOR

Sahiwal Teaching Hospital, Sahiwal

Locations

Sahiwal Medical College,Sahiwal

Sahiwal, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

98/IRB

Identifier Type: -

Identifier Source: org_study_id