Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06377605 |
| Other study ID # |
MD-15-2024 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 10, 2023 |
| Est. completion date |
August 30, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Kasr El Aini Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The epidemic of overweight and obesity presents a major challenge to chronic disease
prevention and health across the life course around the world. [1] Bariatric surgery has
proved to be an efficient intervention in the management of obesity. As a result, the number
of post-bariatric surgery patients in the population is growing [2].
Postoperative analgesia presents various challenges in vulnerable patient groups suffering
from obesity. With the high potential risk of respiratory depression and postoperative
pulmonary complications associated with opioid use, such as atelectasis and pneumonia, the
availability of other pain management modalities is essential [14].
Ultrasound-guided erector spinae plane block (ESPB) is a regional anesthesia technique where
local anesthetic agent is injected deep to the erector spinae muscle to fascial plane and
allowed to diffuse caudally and cranially. It is supposed to provide both visceral and
somatic abdominal analgesia [3].
ESPB is effective, easy to perform, and can be performed in a short time. [4] It has been
shown efficacy in different conditions such as thoracic surgery, trauma, cardiac surgery,
breast surgery, and abdominal surgery [5]. However, the main concern with the ESPB block is
feasibility together with the potency of the block in challenging populations, such as
patients suffering from obesity.
Peripheral nerve blocks in the obese may pose challenges, like difficulties in proper patient
positioning and landmark identification. However, Ultrasound guidance may help overcome many
difficulties in regional techniques. But as expected, targets are more deeply situated in
obese patients and the ultrasound beams are attenuated as they travel a greater distance
through tissue layers. Additionally, when crossing a tissue boundary, a portion is reflected
back to the transducer creating artifacts like speckling and clutter which are particular
problems in the obese patient. [15] Few studies examined the use of ESPB in bariatric surgery
[3,6,7], all indicating potential benefits of the technique in terms of opioid sparing and
pain control. To date, the efficacy of ESPB has not been examined in superobese patient.
So we aim to compare the perioperative analgesic effect of bilateral ultrasound-guided ESPB
with controls, Local bupivacaine infiltration to the trocar sites, in super obese patients
undergoing bariatric surgery We hypothesis that ESBP provides good applicable modality of
perioperative analgesia for superobese patients undergoing bariatric surgeries.
Description:
Following approval from Ethics and Research Committee of Anaesthesia Department, Faculty of
Medicine, Cairo University; 60 patients fulfilling inclusion criteria will be included in
this randomized prospective comparative trial.
A.preoperative:
History will be taken from all patients. Age and then American Society Anaesthesiologists'
(ASA) score will be recorded.
Preoperatively patients' laboratory investigations as complete blood picture, coagulation
profile, liver and renal functions will be recorded. General examination will be carried out
with examination of the back to exclude infection at the injection site and anatomical
deformities.
Baseline vital signs will be recorded including non-invasive measurement of systolic, mean,
diastolic arterial pressures, and HR and oxygen saturation. After inserting an intravenous
(IV) access, the patient will be pre-medicated with metoclopramide in a dose 0.1-0.2 mg/kg.
Patient will be randomly assigned into 1 of 2 groups according to the intervention used
whether:
- Group A (30 patients): Erector Spinae block .
- Group B (30 patients): local anaesthetic infiltration. Upon arrival to O.R;
perioperative monitoring including continuous Electro Cardio Gram (GE-Datex Ohmeda 5
leads ECG cable), pulse oximetry (GE- Datex Ohmeda finger SpO2 sensor), non-invasive
arterial blood pressure (GE-Datex Ohmeda NIBP cuff) will be applied.
In group A, block will be performed by the primary investigator the the block will be
performed preoperatively with 1mg midazolam administration intravenous , and 5 cm lidocaine
1% infiltration at each side prior to the block .
the patient will be placed in the lateral or sitting position . Then, the Erector Spinae
block will be given by a high-frequency linear ultrasound transducer of Siemens acuson x300
3-5MHz ultrasound . It will be sagittally placed against the target vertebral level ( T7
transverse process ) [8] in the lateral or sitting position and moved in approximately 3-cm
lateral to the spinous process . The Erector Spinae muscle and transverse process will be
then identified, and a blunted tip , 20-gauge, short bevel needle (Pajunk Sonoplex,
Geisingen, Germany) will be advanced, using the in-plane approach, in cephalad-to-caudal
direction, through the interfascial plane between the Erector Spinae and the underlying
transverse process under strict aseptic precautions until the tip is deep to erector spinae
muscle, as evidenced by visible hydro-dissection below the muscle plane, and on injection of
5 ml normal saline to confirm the correct needle tip position. The block will be performed
bilaterally by injecting 60 mL of 0.25% bupivacaine (30 mL into each side) [16] into the
fascial plane between the deep surface of the Erector Spinae muscle and the transverse
processes of the lumbar vertebrae laterally (at the most lateral part of the transverse
process) and since it is a fascial plane block , the greater the volume of the local
anaesthetic injected , the distribution will be better.
B.intraoperative:
Then, general anaesthesia will be induced in both groups . 1-2 μg/kg fentanyl based on lean
body weight [3] with maximum dose of 200 μg and 2 mg/kg propofol will be given based on total
body weight [3]. Tracheal intubation will be facilitated with 0.5 mg/kg atracurium based on
ideal body weight [10].
In Group (B) Control group : the participant will receive 5 ml bupivacaine infiltration to
each trocar site (total of 25 ml 0.5 %) at the beginning of the operation.
For both groups, Anaesthesia will be maintained using isoflurane in oxygen and air.
Additional doses of 0.1 mg/kg atracurium will be administrated every 30 minutes. The surgical
intervention will be then allowed 20 minutes after finishing the block procedure in group
(A).
Pressure control volume guarantee ventilation will be adjusted to maintain normocapnia.
Anesthesia will be maintained by using 1-1.5% isoflurane in a mixture of oxygen and air
(50/50) and atracurium top ups at a dose of 0.1mg/kg every 30 minutes.
All participants will be given 1 gram of intravenous paracetamol with maximum dose of 4 gm
every 24 hour Failed block ( increase in HR and mean arterial blood pressure (MABP)>20% from
base line with skin incision) will be treated by 1ug /kg of fentanyl as top-up doses and
increasing isoflurane concentration in case of inadequate response to fentanyl.
20 minute before the end of the surgery ketorolac 0.5mg/kg diluted in 100 ml of saline will
be given intravenously After skin closure, inhalational anesthesia will be discontinued and
reversal of muscle relaxation with atropine (0.02 mg/Kg) and neostigmine (0.05 mg/Kg) will be
administered intravenous after return of patient's spontaneous breathing. Patients will then
be transferred to post anesthesia care unit (PACU) for 60 min to complete recovery and
monitoring.
At any time hypotension (defined as a decrease in mean arterial pressure (MAP) >20% from
baseline value or systolic arterial pressure (SAP <100 mmHg) will be treated with 5 mg IV
bolus ephedrine and repeated every 3 minutes until the hypotension resolved. Bradycardia
(defined as a HR <40 beats per minute ) will be treated with atropine 0.5 mg IV.[11]
C.postoperative:
In the PACU; VAS will be assessed 15 min after extubation and when the score exceeds 3/10,
rescue analgesia in the form of nalbuphine 0.1 mg/Kg with maximum dose of 30 mg every 24
hours will be given. Another dose of nalbuphine 0.1 mg/kg can be given in the PACU if the
score still more than 3 after 30 min of the 1st dose.
After discharging from the PACU, the analgesic plan will be intravenous paracetamol one gram
every 8 hours , ketorolac 0.5mg/kg/ 6 hours if VAS score > 3 and nalbuphine as second rescue
analgesia 0.1 mg/kg /8 hours as long as the pain score is more than 3\10 ( reassessment to be
done after 30 mins of administration of first rescue analgesia ) .
3. Measurement tools
- Patients characteristics including patient's age in years, weight in kilograms,BMI,
gender, type of surgery.
- All hemodynamic parameters as blood pressure using non-invasive measurement, heart rate,
oxygen saturation will be recorded at baseline , 5 mins after intubation ,every 10 min
till the end of the surgery , immediately after extubation , 5 min after extubation ,
and every 10 mins in PACU for 30 min till the discharge of the patient .
- Failed blocks will be documented (patient requirement of consecutive rescue analgesia).
- the patients will be evaluated regarding the time to first demand to rescue analgesia
postoperatively.
- The pain will be assessed by the VAS score, It will be performed in the immediate
post-operative period every 30 min for the first hour , 2 h, 4 h, 8h, 12h and 24 h.
Breakthrough pain will be defined as VAS >3 at rest.
- Pain will be classified as mild (VAS 1-3), moderate (VAS 4-6), and severe (VAS 7-10) .
- Postoperative regular analgesia will be prescribed for all patients in the form of
paracetamol every 8 hours. Rescue analgesia will be administered, if VAS is >3 at any
time with IV ketorolac 0.5 mg/kg diluted in 100 ml normal saline and administered slowly
every 6 hours .
Reassessment of VAS score will be done and if VAS is still > 3 the second rescue analgesic
planned will be IV nalbuphine 0.1 mg/kg every 8 hours .
- The time interval between the first and the second rescue analgesia will be 30 minutes
if VAS score remains persistently >3 .
- Time at which the patient start to ambulate in both groups will be recorded [12]
- PONV in first 24hr will be monitored and documented if occurred.
- complications such as hematoma at the site of injection and local anesthetic
toxicity will be documented .
- Quality of recovery questionnaire.QoR15.
VI. Study outcomes
1. Primary outcome Total opioid consumption (morphine equivalent dose) in both groups in
24hr postoperative (including Intraoperative fentanyl , and postoperative nalluphine).
2. Secondary outcome(s)
1. VAS score during first 24 hour postoperative
2. Failure rate in performing the block
3. Patient demographic data (age ,sex ,ASA classification ,BMI and type of surgery).
4. Postoperative nausea and vomiting in first 24 hours.
5. Time at which the patient start to ambulate in both groups
6. Haemodynamic parameters (heartrate,Blood pressure) recorded intraoperative
,immediately postoperatively and in PAICU.
7. Incidence of complications related to the block as infection or hematoma at the
site of injection , local anaesthetic toxicity or pneumothorax .
8. Time for first rescue analgesia in both groups.
9. Quality of recovery questionnaire (QoR15) after 24hr from the end of the surgery
