Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06403020
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-05-03
Brief Title:
Ultrasound-guided Quadratus Lumborum Block Versus Rectus Sheath Block
Sponsor:
Fayoum University Hospital
Organization:
Fayoum University Hospital
Study Overview
Official Title:
Ultrasound-guided Quadratus Lumborum Block Versus Rectus Sheath Block in Paraumbilical Hernia in Adults A Prospective Randomized Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study we will compare the effectiveness of quadratus lumborum block and rectus sheath block in postoperative pain management after paraumbilical hernia repair
Detailed Description:
patients will be allocated randomly into two groups by a computer generated sequence using closed envelope method Group Q n23 will have qadratus lumboroum QL block
Group R n23 will have rectus sheath RS block Surgery will be performed by the same surgeon and the block also will be done by same anesthesiologist who will not be involved in postoperative assessment
All patients will have a preoperative history taking clinical examination and routine preoperative laboratory investigations will be done Patients also will be learned how to deal with the VAS score before surgery The visual analog scale VAS is a pain score at which a 10-cm line with two ends no pain on the left end and the worst pain on the right end used to track pain for a patient or to compare pain between patients1213 At operating room OR patients will be monitored by noninvasive blood blood pressureNABP peripheral oxygen saturation spo2 and and electrocardiogram ECG A peripheral intravenous cannula will be inserted Patients will be premedicated by midazolam 1-2 mg and they will be pre oxygenated 3-5 minutes before induction of anesthesia General anesthesia will be given using propofol 2-3mgkg intravenousIV fentanyl 1-2µgkg IV and atracurium 05 mgkg IV as a muscle relaxant to facilitate intubation Anesthesia will be maintained by isoflurane and atracurium 01-02 mgkg every 20-30 minutes Patients will be mechanically ventilated with 50 O2 and 50 air keeping end-tidal CO2 between 30 - 35 mmHg Fentanyl bolus doses of 05-1 mcgkg will be given according to the changes of hemodynamic variables more than 20 base line
After the end of the surgery and by the use of Philips clear vue350 Philip Healthcare Andover MAO1810 USA ultrasound probe to perform the block according to the patient group
Group Q patients will receive qadratus lumborum block The procedure will be performed under complete aseptic conditions in the supine position with slight elevation of the ipsilateral pelvis using a high frequency probe 5---10 MHzconnected to an ultrasound unit in transverse orientation the probe will be positioned transversely at the anterosuperior iliac spine ASIS and it will be moved cranially to visualize the three muscle layers of the abdominal wall After identifying the external oblique muscle the probe will be moved posterolaterally to find its posterior border hook sign with the internal oblique muscle below it forming a roof above the quadratus lumborum muscle By tilting the transducer down the middle layer of the thoracolumbar fascia will be seen as a bright hyperechoic line A 21-gauge Stimuplex A 100-mm needle B Braun Melsungen AG Germany will be inserted in-plane in the anterolateral-to-posteromedial direction After negative aspiration 02-04 mlkg of bupivacaine 025 will be injected slowly on each side Group R patients will receive rectus sheath block Under complete antiseptic conditionthe rectus muscle will be identified using a high frequency linear probe with a transverse orientation placed across the abdomen above the level of the umbilicus Starting with the midline the linea alba and rectus muscle on either side will be identified The rectus sheath will appear as hyperechoic fascial plane encircling the rectus abdominis muscle Using an in-plane technique the needle 100-mm needle will be passed through the rectus abdominal muscle to reach the plane between it and the posterior rectus sheath After negative aspiration 02-04 mlkg of bupivacaine 025 will be injected slowly on each side local anaesthetic will be seen peeling the rectus muscle off the posterior rectus sheath
At the end of surgery all anesthetics will be stopped reversal of muscle relaxants will be given patients will be extubated when they will able to breath spontaneously with adequate tidal volume Patients will be transferred to postanesthesia care unit PACU All patients will receive paracetamol 1gmkg every 8 hours All treating and outcome assessors staff will be blinded to the group allocation of the patients At the recovery room patients will assess their pain using VAS score and they will be monitored for postoperative pain Patients will be transferred to the ward and will leave the post anesthesia care unit PACU with Aldrete score more than 9 14 patient with Vas score 4 will recieve a rescue dose of morphine 3-5 mg IV
Group R n23 will have rectus sheath RS block Surgery will be performed by the same surgeon and the block also will be done by same anesthesiologist who will not be involved in postoperative assessment
All patients will have a preoperative history taking clinical examination and routine preoperative laboratory investigations will be done Patients also will be learned how to deal with the VAS score before surgery The visual analog scale VAS is a pain score at which a 10-cm line with two ends no pain on the left end and the worst pain on the right end used to track pain for a patient or to compare pain between patients1213 At operating room OR patients will be monitored by noninvasive blood blood pressureNABP peripheral oxygen saturation spo2 and and electrocardiogram ECG A peripheral intravenous cannula will be inserted Patients will be premedicated by midazolam 1-2 mg and they will be pre oxygenated 3-5 minutes before induction of anesthesia General anesthesia will be given using propofol 2-3mgkg intravenousIV fentanyl 1-2µgkg IV and atracurium 05 mgkg IV as a muscle relaxant to facilitate intubation Anesthesia will be maintained by isoflurane and atracurium 01-02 mgkg every 20-30 minutes Patients will be mechanically ventilated with 50 O2 and 50 air keeping end-tidal CO2 between 30 - 35 mmHg Fentanyl bolus doses of 05-1 mcgkg will be given according to the changes of hemodynamic variables more than 20 base line
After the end of the surgery and by the use of Philips clear vue350 Philip Healthcare Andover MAO1810 USA ultrasound probe to perform the block according to the patient group
Group Q patients will receive qadratus lumborum block The procedure will be performed under complete aseptic conditions in the supine position with slight elevation of the ipsilateral pelvis using a high frequency probe 5---10 MHzconnected to an ultrasound unit in transverse orientation the probe will be positioned transversely at the anterosuperior iliac spine ASIS and it will be moved cranially to visualize the three muscle layers of the abdominal wall After identifying the external oblique muscle the probe will be moved posterolaterally to find its posterior border hook sign with the internal oblique muscle below it forming a roof above the quadratus lumborum muscle By tilting the transducer down the middle layer of the thoracolumbar fascia will be seen as a bright hyperechoic line A 21-gauge Stimuplex A 100-mm needle B Braun Melsungen AG Germany will be inserted in-plane in the anterolateral-to-posteromedial direction After negative aspiration 02-04 mlkg of bupivacaine 025 will be injected slowly on each side Group R patients will receive rectus sheath block Under complete antiseptic conditionthe rectus muscle will be identified using a high frequency linear probe with a transverse orientation placed across the abdomen above the level of the umbilicus Starting with the midline the linea alba and rectus muscle on either side will be identified The rectus sheath will appear as hyperechoic fascial plane encircling the rectus abdominis muscle Using an in-plane technique the needle 100-mm needle will be passed through the rectus abdominal muscle to reach the plane between it and the posterior rectus sheath After negative aspiration 02-04 mlkg of bupivacaine 025 will be injected slowly on each side local anaesthetic will be seen peeling the rectus muscle off the posterior rectus sheath
At the end of surgery all anesthetics will be stopped reversal of muscle relaxants will be given patients will be extubated when they will able to breath spontaneously with adequate tidal volume Patients will be transferred to postanesthesia care unit PACU All patients will receive paracetamol 1gmkg every 8 hours All treating and outcome assessors staff will be blinded to the group allocation of the patients At the recovery room patients will assess their pain using VAS score and they will be monitored for postoperative pain Patients will be transferred to the ward and will leave the post anesthesia care unit PACU with Aldrete score more than 9 14 patient with Vas score 4 will recieve a rescue dose of morphine 3-5 mg IV
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None