Ultrasound Guided Transversus Abdominis Plane Block Versus Erector Spinae Plane Block in Patients Undergoing Emergency Laparotomies.
Phase: NA
Conditions: Postoperative Pain, Laparotomy
Sponsor: Hassan Mokhtar Elshorbagy Hetta

Patients & Methods  
 
 
 
 
 
Official Title 
Ultrasound guided transversus abdominis plane block versus 
erector spinae plane block in patients undergoing emergency 
laparotomies 
 
 
NCT03989570 
 
 
 
Date of document 8/3/2020 
 
 
 
 
 
 
 
 

Patients & Methods  
Patients and methods 
After obtaining Institutional Ethical Committee approval and written 
informed consent was obtained from all patients' relatives, this prospective 
randomized double blind controlled study conducted on 90 adult patients of 
both sex at El-Minia University Hospital in the period from july 2018 to june 
2019 aged 20-50 years, of American Society of Anesthesiologists (ASA) 
physical status I Emergency to III Emegency, scheduled for emergency 
laparotomies under general anesthesia. 
Exclusion criteria: 
Patient refusal 
   History of allergy to the studied Drugs. 
 
   Opiod dependence. 
   Morbid obesity (BMI >40 kg/m2). 
   Psychiatric and neurological disorders. 
   Bleeding disorders. 
   Skin lesion or wounds at the site of proposed needle insertion. 
   Major Organ dysfunction. 
   Failed block. 
   Patients remain intubated after surgery. 
Preoperative management: 
A careful medical history, through physical examination including: CNS, 
chest, heart, abdomen, lower limbs and back and necessary investigations were 
done such as complete blood picture, renal and liver function tests, random 
blood sugar, and electrocardiogram were performed and analyzed in detail 
prior to procedure. 
 

Patients & Methods  
We explained to the patients how to evaluate their own postoperative pain 
intensity using 10-point linear visual analogue scale (VAS), scored from 0-10 
(where 0=no pain and 10=the worst pain). To score VAS, use a ruler, the score 
is determined by measuring the distance (mm) on the 10-cm line between 
the “no pain” anchor and the patient's mark. 
Equipments and drugs used in the study (fig. 1): 
1.  Ultrasound machine and scanning probe, the used one was SONOSITE 
M-TURBO , the scanning probe was the linear multi- frequency 13-6 
MHz transducer  made in USA. 
2.  22-gauge Quinke needle for skin infiltration manufactured by GMS              
in Egypt. 
3.  10 mL syringes for injection. 
4.  Sterile gloves. 
5.  Sterile towels and gauze packs. 
       6.  Sunnypivacaine 0.5% vial 20ml: 5mg in each 1ml (sunny pharmaceuticals 
). 
 
 
Figure(1 ):sterile equipments and drugs used 
 
 
Anesthetic management: 

Patients & Methods  
On arrival to the operating theatre, standard monitoring was applied 
including noninvasive blood pressure (NIBP), Electrocardiography (ECG) and 
pulse oximetry (NIHON KOHDEN) or (PHILIPS monitor, model: Efficia 
CM120). Then an intravenous 18 G cannula was inserted after sterilization of the 
skin and preloading with Ringer's lactate solution 10-15 ml/kg was given.  
All patients received the same anesthetic technique; were premeditated by 
intravenous midazolam 0.05 mg/kg and fentanyl 1 μg/kg. Induction of anesthesia 
was accomplished by 2 mg/kg of 1% propofol followed by atracurium 0.5 mg/kg 
to facilitate tracheal intubation with an appropriate size cuffed endotracheal tube. 
Anesthesia was maintained with inhalational isoflurane (MAC 1-1.5 in O2) 
and atracurium bolus 0.1 mg/kg. Mean arterial pressure, Heart rate (HR) SpO2 
and end tidal CO2(ETco2) were recorded before and after induction, after 
intubation and every 10 min intervals until the end of the operation. If  
hemodynamics  increased more than 20 % of base line a rescue analgesia in the 
form of  fentanyl (0.5 mic/kg) was given.  Ventilation was controlled with tidal 
volume of 6-8 ml/kg and respiratory rate of 12-14 breaths/min. The ventilation 
parameters were adjusted to keep end-tidal CO2 at 30-35 mmHg with PEEP of 3-
5 cmH2O and O2 flow of 5 L /min. Intravenous fluid therapy was given according 
to the calculated formula (4/2/1 rule) per fasting hours for maintenance of fluid 
requirements, 4 ml/kg/h for third space loss and replacement of surgical bleeding 
if present.  
Nasogastric tube was inserted for all patients after intubation and was 
removed at the end of the surgery Then, bilateral ultrasound guided TAP or ESP 
block was given according to groups. The surgical intervention was started 15 
min after the block. 
Before the end of the surgery, residual neuromuscular blockade was 
reversed with injection of neostigmine 0.05mg/kg and atropine 0.01mg/kg. 
After full recovery, the patients were transferred to postoperative care 
unit and received postoperative care and monitoring of hemodynamics, 

Patients & Methods  
analgesics in the form paracetamol 15 mg/kg/6 hs IV (paracetamol 100ml 1%, 
Pharco B International) was given with a maximum dose of 90 mg/kg/day . 
Study groups: 
The patients were randomly allocated into three parallel equal groups (30 
patients in each group) by using a computer-generated table. The patient and 
the staff providing the  postoperative care were blinded to the group assignment. 
     Group A (Controlled group): anesthetized with the protocol followed 
by Minia University Hospital. 
 Group  B  (Transverse abdominis plane (TAP) block):  received  
ultrasound  guided  four quadrants injection TAP block using a bolus 
injection of 40 ml isobaric bupivacaine hydrochloride 0.25% before 
skin incision (10ml on each quadrant). 
 Group C (Erector Spinae Plane (ESP) block): received ultrasound 
guided bilateral injection ESP block using a bolus injection of 40 ml 
isobaric bupivacaine hydrochloride 0.25% before skin incision (20 ml on 
each side). 
 
 
 
 
Transverse abdominis plane (TAP) block  
While positioning of the patient and sterilization of the site of the TAP block 
, the studied drugs were prepared in (10ml)  syringes of total volume 40 ml. 
To perform posterior TAP, with the anesthetist standing on the same side of 
the injection, the ultrasound probe was prepared and was positioned on the 
abdominal wall in the mid-axillary line between the iliac crest and the costal 
margin and carefully moved postero-laterally for optimal identification of the 
transversus abdominis fascial plane        (fig. 2). The image produce showed 

Patients & Methods  
(from superficial to deep) skin and subcutaneous tissue, fat, external oblique, 
internal oblique, and transversus abdominis  muscles, and lastly the 
peritoneum and bowel may be seen deep to the muscles. The 3 muscle layers 
can be seen running parallel to one another (fig 4). When an adequate ultrasound 
image was obtained, A 22-G 90-mm spinal needle attached with tubing system 
to a syringe filled with the local anesthetic was inserted anterior in-plane with 
the probe. 
Once the tip of the needle was visualized to be in plane between the 
internal  oblique  and  the  transversus  abdominis  muscle  and  after  careful 
aspiration to exclude vascular puncture,10 ml of the local anesthetic was slowly 
injected. If the needle was correctly positioned, the fascial plane was seen to 
separate (hydrodissection) and form a well-defined hypoechoic, elliptical shape 
between the internal oblique and transversus abdominis muscles. If a patchy 
opacity appears within the muscle either superficial or deep to the transversus 
abdominis plane, the needle should be repositioned until local anesthetic was 
seen to spread  within  the plane, separating the fascia between the muscles. 
Then the ultrasound probe moved to be placed under the costal margin 
for subcostal TAP block which was performed in a similar manner then the TAP 
was performed on the opposite site by the same technique.   
 
 
 

Patients & Methods  
Figure 2 : Technique of TAPB (EL-Minia university hospital) 
 
Figure 3: Ultrasound image of TAPB (EL-Minia university hospital) 
 
 
 
 
 
Erector Spinae Plane (ESP) block 
While on group (C), positioning of the patient on the lateral position, 
After identifying the level of the intervertebral space (inferior angle of scapula 
opposite to spinous process T7 or C7 most prominent spinous process 
downward to T8)  and sterilization of the site of the ESP block, the studied 
drugs were prepared in (10ml)  syringes of total volume 40 ml. 
After identifying the level of the intervertebral space, the transverse 
process was traced laterally after identifying the spinous processes and 
lamina approximately 2.5–3 cm from midline in longitudinal position. The 
transverse process is identified as a hyperechoic curvilinear structure with 
pronounced finger-like acoustic shadowing beneath (trident sign) with 
lamina (sawtooth pattern) and spinous process medially and costochondral 

Patients & Methods  
junction laterally. The transverse process has a square contour as compared 
to rib with rounded contour. The image produce showed (from superficial to 
deep) skin and subcutaneous tissue, trapezius and erector spinae with 
simmering pleura in between the transverse processes  (fig. 4). 
The block was administered by in-plane technique using A 22-G 90-
mm spinal needle  (approximately 1–2 cm away from the probe and advance 
at a 30–45-degree angle towards the ultrasound beam) attached with tubing 
system to a syringe filled with the local anesthetic was inserted in cranial–
caudad direction and the block needle was advanced through skin, S.C, the 
trapezius and erector spinae to gently contact transverse process. Needle 
placement was confirmed by hydrodissection on injecting 2–3 ml of normal 
saline. Then 20 ml of 0.25% bupivacaine was injected on both sides. On 
injecting 10 ml of 0.25% bupivacaine into interfascial plane deep to erector 
spinae, a visible linear pattern was visualized lifting the muscle.  
 
Figure 4 : Ultrasound image of ESPB (EL-Minia university hospital) 
 
Parameters assessed & analyzed: 
1. Hemodynamics 

Patients & Methods  
  Basal MAP and HR   after induction, at time of filteration,  at 5, 10 ,15, 
20, 30, 45, 1h, 1.5h, 2hrs and 2.5hrs after the block then heart rate and mean 
arterial pressure  were recorded at 1,2,4,6,8,10,12,18,24 hrs post-operatively. 
2. Recovery score : 
The modified Aldrete scoring system for determining when patients are 
ready for discharge from the postanesthesia care unit 
3. Visual analogue pain score (rest and dynamic): 
Severity of pain was assessed using Visual Analogue pain scale (VAPS) 
ranging from 0 to 10. Pain assessment was done by the patients at rest and at 
movement (sitting position)  at the following time points: at 1, 2, 4, 6, 8, 10, 12, 
18 and 24 hrs Postoperatively after full recover . 
If VAS was ≥4 at rest, rescue analgesia was given in the form 
intravenous fentanyl (Manuf pharmaceuticals. by sunny - Egypt, under license 
of Hameln pharmaceuticals- Germany) at 0.5μg/kg was given. Time of 1st 
analgesic request was recorded. If the analgesia was not adequate (VAS ≥4 for 
20 min after fentanyl injection) another dose of fentanyl at 0.5μg/kg was given 
and total analgesic requirement of fentanyl were recorded. 
4. Time of first analgesic request. 
  Defined as the time from the end of surgery until the first patient’s request 
for analgesia; it was recorded and compared between groups. 
5. Patient satisfaction:  
According to patient satisfaction score which is a measure of overall 
satisfaction with the quality of analgesia provided by asking the patient to rate 
their satisfaction level based on score 1-4 satisfaction score criteria 
(4)  Excellent = No complaint from the patient 
(3)  Good       = Minor complaint with no need for analgesia 
(2)  Fair          = Complaint which required supplemental analgesia 
(1)  Bad      =   Patient given maximal dose analgesia. 

Patients & Methods  
6. Total analgesic requirement over 1st 24 h 
The total amount of  fentanyl (postoperative) was given to the patients as 
rescue analgesia during 24 hours.  
7. Incidence of any side effect: 
Incidence of post-operative complications related to the drugs or technique as    
• Postoperative nausea and vomiting: The severity of postoperative nausea and 
vomiting (PONV) was graded on a four-point ordinal scale (I) not at all, (II) 
sometimes, (III) often or most of the time, and (IV) all of the time with 
vomiting (Myles & Wengritzky, 2012). Rescue antiemetic ondansetron 4 mg 
IV was given to all patients with PONV score more than II. 
• Itching  
• Urinary retention  
• Bradycardia and hypotension 
• Respiratory depression 
• Technique related complications as hematoma formation at the injection site, 
vascular or lymphatic injury, neurologic symptoms and local anesthetic 
toxicity 
The study outcome 
• Primary outcome: 
Our primary outcomes were to evaluate pain score (VAPS)t rest and at 
movement (sitting position)  
• Secondary outcome: 
Our secondary outcomes were to assess post-operative analgesia in the form 
of time of first analgesic request and total analgesic requirements,  hemodynamics, 
patient satisfaction  and side effects or complications. 
 
Sample Size Calculation: 
 

Patients & Methods  
Before the study, the number of patients required in each group was 
determined after a power calculation according to data obtained Pilot study (6 
patients within each group). In that study, mean VAS at 24 in group A was 3.16, 
in group B was 2.5 and in the group C was 2.16; (with SD = 1 in each group). 
A sample size of  31 patient in each group was determined to provide 95% 
power for one way ANOVA test at the level of 0.05 significance using G Power 
3.1 9.2 software. 
 
 
Test family: F tests                           
Statistical test: ANOVA: Fixed effects, omnibus, one-way 
 
Type of power analysis: A priori: Compute required sample size 
Input parameters:                                           Output parameters: 
Effect size f 
=0.4151573                      Noncentrality parameter ë= 16.0290693 
á err prob =0.05                                     Critical F=3.0976980 
Power (1-â err prob)=0.95                       Numerator df=2 
Number of groups=3                               Denominator df=90 
                                              Total sample size=93 
                                              Actual power=0.9507147 
Statistical analysis 
The analysis of the data was carried out using the IBM SPSS 20.0 statistical 
package software. Data were expressed as mean±SD, minimum and maximum of 
range for quantitative parametric measures or median and interquartile range 
(IQR) in quantitative non-parametric measures in addition to both number and 
percentage for categorized data.  
Analysis of variance (ANOVA) was used for comparison between 
independent groups for parametric data followed by LSD post hoc test to assess 

Patients & Methods  
intergroup differences, Kruskal Wallis test for non-parametric quantitative data 
followed by Mann Whitney test to compare each two groups and the Chi-square 
test or Fisher’s exact test were used to compare categorical variables. 
Analyses were done for parametric quantitative data within each group 
using paired sample t test, and for non-parametric quantitative data using 
Wilcoxon signed rank test.  
A P-value of 0.05 or less was considered significant, whereas values 0.01 
and 0.001 were considered highly significant.