Comparison two blocks for Postoperative analgesia in Lumbar Spine Surgeries
- Conditions
- Fracture of lumbar vertebra, (2) ICD-10 Condition: S345||Injury of lumbar, sacral and pelvic sympathetic nerves,
- Registration Number
- CTRI/2024/04/064962
- Lead Sponsor
- Department of Anaesthesiology
- Brief Summary
Background and Rationale
Spinal procedures are generally associated with intense pain in the postoperative period, especially for the initial few days. Adequate pain management in this period has been seen to correlate well with improved functional outcome, early ambulation, early discharge, and preventing the development of chronic pain(1).
Therefore, combination therapy or multimodal analgesia for proper control of pain appears as the best approach in this regard.
The Modified Thoracolumbar Interfascial Plane (TLIP) block and Erector Spinae Plane Block are two novel plane blocks which have been shown to be effective for postoperative analgesia in lumbar spine fusion surgery.
The ESP block was first described by Forero et al. in 2016 for the treatment of thoracic neuropathic pain(2). ESP block has been reported to provide effective postoperative analgesia in thoracic and breast surgery, bariatric surgery and upper abdominal surgery. Recently ESP block has been reported to provide effective postoperative analgesia in veretebra surgeries(3,4). The mechanism of ESP analgesic action has been demonstrated in cadaver studies where injected local anesthetics caused by diffusion of the spinal nerves into the ventral and dorsal rami by spreading in the cranial and caudal directions. ESP block relieves incisional pain by creating an effective block in a wide area of the posterior, lateral and anterior thoracic and lumbar walls. In addition, ESP block prevents visceral autonomic pain and provides good postoperative analgesia
On the other hand TLIP block was first defined by Hand et al. in 2015(5). They injected local anesthetic between the multifidus and longissimus muscles at the third lumbar vertebral level by positioning the block needle at a 30° angle from the skin, and then they advanced the needle from lateral to medial (classic technique)6.
Later, Ahiskalioglu et al. asserted that advanng the needle from lateral to medial might have a risk of inadvertent neuroaxial injection. Also, sonographic imaging of the longissimus and iliocostalis muscles can be easier than imaging the multifidus and longissimus muscles. Therefore, Ahiskalioglu et al. devised and described a modified TLIP block in which a local anesthetic is injected between the longissimus and iliocostalis muscles with a needle angled at 15° and the needle is advanced medial to lateral (lateral technique)7
The mechanism of mTLIP is to target the dorsal rami of the lumbar nerves. It provided effective analgesia management following lumbar spine surgical procedures in several studies. Moreover, the mTLIP block could block the dorsal rami of the lumbar nerves8. In several randomized studies and case reports, the mTLIP block was found to provide adequate pain management following lumbar spine operations.
Though both these blocks have been shown to be effective for post-operative analgesia in patients following lumbar spine surgeries, but not many studies have been done to compare the two for the same. Therefore we planned this study to compare Modified TLIP block and ESP block for their effect on postoperative analgesia following lumbar spine surgery.
Bahadır ÇIFTÇI(2019)(10) conducted study to examine the practicality and analgesic efficacy of US-guided mTLIP and cTLIP blocks following lumbar disc surgery under general anesthesia in sixty patients aged 18–65 years with an American Society of Anesthesiologists classification of I or II. US-guided mTLIP (n=30) and cTLIP (n=30) blocks were performed. The performance time of the block procedures, the success of a one-time block, postoperative pain scores, opioid consumption, adverse effects, and block-related complications were recorded and analyzed. The performance time was significantly less in the mTLIP group (p0.05). The results showed that a US-guided mTLIP block had a shorter performance time and a higher one-time block success rate compared with the cTLIP block. The quality of analgesia provided by the mTLIP and cTLIP blocks was similar
Bahadir Ciftci, et al (2020)(11) performed a stusy to compare the ultrasound (US)- guided erector spinae plane block (ESPB) and modified-thoracolumbar interfascial plane (mTLIP) block for postoperative pain management in lumbar discectomy surgery patients. They then concluded that Postoperative opioid consumption at all
time intervals were significantly lower both in ESPB and mTLIP groups compared with the control group ( P < 0.05). No significant difference was observed concerning intra- and postoperative opioid consumption between the ESPB and the mTLIP group ( P < 0.001). Passive VAS score at the postanesthesia care unit, second, fourth, and eighth hours, and active VAS score at the postanesthesia care unit, second, fourth, eighth, and 16th hours were significantly lower in the ESPB and mTLIP groups compared with the control group ( P < 0.05). The use of rescue analgesia was significantly lower in the ESPB and mTLIP groups than in the control group (9/30, 7/30, and 21/30, respectively, P < 0.001). The block procedure time was similar between groups ( P = 0.198). It then concluded that US-guided ESPB and mTLIP block may provide adequate pain control after discectomy surgery. However, there is a nonsuperiority between ESPB and the mTLIP groups
Erkan Cem ÇELIK (2020)(8) aimed to examine the effect of epidural analgesia at closure (EAC) versus modified thoracolumbar interfascial plane (mTLIP) block on postoperative opioid consumption in patients undergoing lumbar discectomy in sixty patients. There was statistically no difference in terms of opioid consumption from zero to 4th hr and VAS scores in the 1-2 hrs postoperatively (p > 0.05) between groups. At 4-12 hrs and 12-24 postoperatively hrs intervals, total opioid consumption was significantly lower in Group mTLIP compared to Group EAC (p
< 0.05). At the 4th, 8th, 12th, and 24th hrs VAS scores were lower in Group mTLIP compared to Group EAC (p < 0.05). Rescue analgesia usage was significantly higher in the Group EAC than in the Group mTLIP, e.g. 11/30 vs. 3/30 respectively (p = 0.015). It concluded that Preoperative bilateral, ultrasound-guided modified thoracolumbar interfascial plane block offers more effective postoperative analgesia, thus reducing tramadol consumption as compared to epidural analgesia at closure after lumbar discectomy surgery.
Tantri A R, Sukmono R B,(2022)(12) aimed to assess postoperative pain and serum levels of pro-inflammatory IL-6 after posterior lumbar decompression and stabilization surgery with a classical and modified technique of TLIP block. It was a prospective randomized, single-blinded controlled pilot study conducted on eight patients undergoing posterior lumbar decompression and stabilization surgery. Intraoperative hemodynamic (blood pressure and heart rate) and noxious stimulation response level (qNOX), postoperative IL-6 level, 24-hour morphine consumption, and numerical rating score were recorded and analyzed. Through this study they concluded that modified TLIP block resulted in lower IL-6 level and NRS 12 hours postoperatively compared to classical TLIP block. The median of IL-6 level was found to be lower in the modified TLIP group 12 hours postoperatively compared to classic TLIP (29.91 (8.56 – 87.61) vs. 46.87 (2.87 – 92.35)). The mean Numerical Rating Scale (NRS) in the modified TLIP block was comparable with the classic TLIP group, although it was lower than the classic TLIP group (2.75 ± 1.5 vs. 3.75
± 1.7 at 6 hours and 3.5 ± 1.3 vs. 4 ± 1.6 12 hours postoperatively). However, there were no differences in total postoperative morphine consumption between the two groups.
Pavithran, (2022)(13) Compared TLIP with wound infiltration for post operative analgesia in seventy one patients. The median (interquartile range) duration of the time of the first request for rescue analgesia was 1440 (1290, 2280) min in the TLIP group and 340 (180, 360) min in the infiltration group; P value <.001. The mean tramadol consumption was significantly higher in the infiltration group compared to the TLIP group, with a P value <.001. The study concluded that TLIP block provided better postoperative analgesia than that provided by wound infiltration with local anaesthetic.
Hypothesis:
Modified Thoracolumbar Interfascial Block is more effective than Erector Spinae Plane Block for post operative analgesia following Lumbar Spine Surgeries
Aim : To compare efficacy of Modified Thoracolumbar Interfascial Plane Block with Erector Spinae Plane Block for postoperative analgesia following Lumbar Spine Surgeries .
OBJECTIVES:
Primary objective: To compare the groups with regards to VAS Score at 4th hour.
Secondary objectives : To compare the groups with respect to following parameters:
a) Post-operative Pain and comfort both during rest and movement
b) Time to First Rescue Analgesia
c) Total rescue analgesia required in fist 24 hours post surgery
d) Time of block performance
e) One time block success rate
f) Hemodynamic parameters and complications if any
MATERIAL AND METHODS
 Study Settings: The study will be conducted in Department of Anaesthesiology, King George’s Medical University, Lucknow after getting approval from Institutional Ethical Committee
 Study design: Randomized controlled double blind comparative study.
 Study duration: 1 Year
Sample size: THE STUDY WHICH WAS USED AS REFERENCE FOR THE SAMPLE CALCULATION WAS BY CELIK EC ET AL. TABLE NO. 3 OF COMPARISION OF VAS SCORE IN WHICH THE SIGNIFICANT DATA WAS OBTAINED AT THE 4TH HOUR. THE TWO GROUPS WERE mTLIP and EAC with 3.00 ± 0.94 AND 3.43 ± 0.67 VAS SCORES (VISUAL ANALOGUE SCALE SCORES).
THE FORMULA USED IS FROM BERNARD 8TH EDITION EQUATION 8.25
µ1=x̄1=3.00
µ2=x̄2=3.43
Δ=µ2-µ1=3.43-3.00=0.43 σ1=S1=0.94
σ2=S2=0.67 α=0.05
1-β=0.8
PUTTING THE VALUES IN THE EQUATION: N1={(0.94)2+(0.67)2}(1.96+0.84)2
(3.43-3.00)2
=(0.8836+0.4489)(7.84)
0.184
=(1.3325)(7.84)
0.1848
=56(each group)
Adding attrition bias of 10%=56+5=61 sample size
Inclusion criteria
• All the patients between 18 to 65 years of age, belonging to ASA Class I and II of either sex, scheduled to undergo posterior Lumbar Spine surgeries will be included.
Exclusion criteria
1) Negative consent / refusal.
2) Patient with BMI more than or equal to 30 kg/m2
3) Patients with history of allergy to any of the drugs
4) Patients with history of Previous Spine surgeries
Methodology:
The study will be conducted after getting approval from ethics committee of King George’s Medical University, Lucknow .After taking written Informed Consent from the patients, they will randomly be allotted any one of the 2 groups based on computer generated system
Group TL: Modified TLIP Block will be given Group ES: ESP Block will be given
After the patient is taken inside Operation Theatre, all the standard monitors will be attached. Under standard monitoring, patient will be induced with FENTANYL 2 µg/kg and PROPOFOL 2–3 mg/kg. VECURONIUM 0.1mg/kg will be given to facilitate muscle relaxation. Patients will then be intubated with a flexo-metallic armoured endotracheal tube of adequate size. Patient will then be positioned prone.
A local anaesthetic mixture consisting of 40 ml of 0.25% BUPIVACAINE will be prepared. Blocks will then be performed by Anaesthesiologist trained in both the blocks. The procedure will be done under sterile precautions.
Patients in the Group TL will receive ultrasound-guided bilateral Modified TLIP block. A high-frequency linear ultrasound probe is to be used for the block. The probe will be placed transversely in the midline position at the level of the L3 vertebra. The spinous process will be identified. The probe will then be moved laterally to identify the paraspinal muscles- longissimus and iliocostalis muscles
with a needle angled at 15° and the needle will be advanced medial to lateral (lateral technique) Hydrodissection using 1 ml of normal saline will be used to identify the correct plane, following which 20 ml of the prepared drug will be deposited, and the block will be repeated on the opposite side.
Patients in Group ES Erector Spinae Plane block will be performed with the same local anaesthetic mixture. Under US-guidance the curvilinear ultrasound transducer will be placed in a cephalocaudal orientation over the midline of the back at the desired level. The probe will then slowly be moved laterally until the transverse process is visible. Upon verification of the transverse process, the trapezius muscle, rhomboid major muscle (if performing at T5 level or higher), and erector spinae muscle will be identified superficial to the transverse process. The needle will then be inserted superior to the ultrasound probe using an in-plane approach in the cephalad to caudal direction. The bevel of the needle will be pointing posteriorly and inferiorly, and advanced under ultrasound guidance through the trapezius muscle, rhomboid major muscle, and erector spinae muscle and towards the transverse process; once the needle tip is below the erector spinae muscle, a small bolus of local anesthetic will be given through the needle. The erector spinae muscle will then be visualized, separating from the transverse process. This separation from the transverse process confirms the proper needle position. The local anesthetic will then be injected in 5 ml increments, with aspiration after every 5 ml to prevent intravascular injection. After negative aspiration, 20 ml of BUPIVACAINE 0.25% will be injected through the needle, and the cranial and caudal spread of the injected fluid will be seen, and the block will be repeated on the opposite side.
One time block success rate and time of performance of block will be noted at the time of block performance
Intraoperatively analgesia will be supplemented with INJ PARACETAMOL 1 gm, which will be given 5 min before the incision is placed and INJ FENTANYL 50ug as per requirement. The heart rate and non-invasive blood pressure will be noted every 10 min for half an hour after the intervention was completed, at the time of incision, and every half hour till the end of surgery.
At the end of surgery, patients will be extubated and shifted to the Post-op ward and monitored for 24 h.
In the Post-op period, VAS and BCS scores will be noted at 4, 6, 12 and 24 hours postoperatively, Time to first Rescue analgesia, Total rescue analgesia required in first 24 hours post-operatively, measures of postoperative pain and comfort, hemodynamic parameters and other complications if any will be noted. Postoperative pain will be assessed using the visual analogue scale (VAS) on a scale from 0 (no pain) to 10 (worst possible pain). Postoperative comfort will be evaluated using the Bruggemann Comfort Scale (BCS). BCS is scored as 0 – persistent pain, 1 – painless in resting state and severe pain either during deep breathing or coughing or both, 2 – painless in resting state and slight pain either during deep breathing or coughing or both, 3 – painless during deep breathing, and 4 – painless during coughing.
The postoperative analgesia will be managed with intravenous INJ PARACETAMOL 1 gm given every eighth hour and INJ TRAMADOL 100mg to be given as rescue analgesia whenever a patient complains of pain and the VAS score is more than four. The postoperative assessment will be done by the Nursing staff attending the patient in Post-op ward, who will be blinded to the treatment allocation.
Statistical Analysis:
SPSS version 21.0 will be used for statistical analysis.
Categorical values will be presented in Number and Percentage (%) and Continuous Variables will be presented as Mean ± Standard deviation and Median. Normality of data will be tested by KOLMOGROV-SMIRNOV TEST. If the Normality is rejected then NON PARAMETRIC TEST will be used.
Statistical tests will be applied as follows:
1. -Quantitative Variables will be compared using UNPAIRED T- TEST/MANN- WHITNEY TEST (When the data sets are not Normally distributed between the two groups)
2. Qualitative Variables will be compared using CHI-SQUARE TEST/FISCHER’S EXACT TEST
The p value of <0.05 will be considered significant.
References:
1. Bajwa SJ, Haldar R. Pain management following spinal surgeries: An appraisal of the available options. J Craniovertebr Junction Spine. 2015;6:105–10. [PMC free article] [PubMed] [Google Scholar]
2. Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The erector spinae plane block: a novel analgesic technique in thoracic neuropathic pain. Reg Anesth Pain Med. 2016;41:621–7. [PubMed] [Google Scholar]
3. Chin KJ, Malhas L, Perlas A. The erector spinae plane block provides visceral abdominal analgesia in bariatric surgery: a report of 3 cases. Reg Anesth Pain Med. 2017;42:372–376. Cited Here
4. Chin KJ, Adhikary S, Sarvani N, et al. The analgesic efficacy of preoperative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia. 2017;72:452–460. Cited Here
5. Hand WR, Taylor JM, Harvey NR, Epperson TI, Gunselman RJ, Bolin ED, et al. Thoracolumbar interfascial plane (TLIP) block: A pilot study in volunteers. Can J Anaesth. 2015;62:1196–200. [PubMed] [Google Scholar] [Ref list]
6. Hand WR et al (2015) Thoracolumbar interfascial plane (TLIP) block: a pilot study in volunteers. Can J Anesth 62:1196–1200
7. Ahiskalioglu A, Alici HA, Selvitopi K, Yayik AM (2017) Ultrasonography- guided modified thoracolumbar interfascial plane block: a new approach. Can J Anesth 64(7):775–776
8. Çelik EC, Ekinci M, Yayik AM, Ahiskalioglu A, Aydi ME, Karaavci NC. Modified thoracolumbar interfascial plane block versus epidural analgesia at closure for lumbar discectomy: a randomized prospective study. Anaesthesia, Pain & Intensive Care. 2020 Dec 4;24(6):588-95.
9. Bernard Rosner. Fundamentals of Biostatistics (5th edition). (Based on equation 8.27).
10. Bahadır ÇIFTÇI. A prospective and randomized trial comparing modified and classical techniques of ultrasound-guided thoracolumbar interfascial plane block. 2019
11. Bahadir Ciftci, Mürsel Ekinci. Ultrasound-Guided Erector Spinae Plane Block versus Modified-Thoracolumbar Interfascial Plane Block for Lumbar Discectomy Surgery: A Randomized, Controlled Study. World Neurosurg. 2020 Dec;144:e849- e855. doi: 10.1016/j.wneu.2020.09.077. Epub 2020 Sep 18.
12. Tantri A R, Sukmono R B, Lumban Tobing S D A, Natali C. Comparing the Effect of Classical and Modified Thoracolumbar Interfascial Plane Block on Postoperative Pain and IL-6 Level in Posterior Lumbar Decompression and Stabilization Surgery. Anesth Pain Med.12(2):e122174. doi: 10.5812/aapm-122174
13. Pavithran P, Sudarshan PK, Eliyas S, Sekhar B, Kaniachallil K. Comparison of thoracolumbar interfascial plane block with local anaesthetic infiltration in lumbar spine surgeries - A prospective double-blinded randomised controlled trial. Indian J Anaesth. 2022 Jun;66(6):436-441. doi: 10.4103/ija.ija\_1054\_21. Epub 2022 Jun 21. PMID: 35903596; PMCID: PMC9316676.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 56
All the patients between 18 to 65 years of age, belonging to ASA Class I and II of either sex, scheduled to undergo posterior Lumbar Spine surgeries will be include.
- Negative consent / refusal.
- Patient with BMI more than or equal to 30 kg/m2 Patients with history of allergy to any of the drugs Patients with history of Previous Spine surgeries.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the groups with regards to VAS 4 hrs to 48hrs Score at 4th hour 4 hrs to 48hrs
- Secondary Outcome Measures
Name Time Method To compare the groups with respect to following parameters: Post-operative Pain and comfort both during rest and
Trial Locations
- Locations (1)
Department of Anaesthesiology
🇮🇳Lucknow, UTTAR PRADESH, India
Department of Anaesthesiology🇮🇳Lucknow, UTTAR PRADESH, IndiaDr HemlataPrincipal investigator9415410236hema2211@yahoo.co.in