Ignite Creation Date:
2024-05-06 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05254093
Status:
COMPLETED
Last Update Posted:
2022-07-26
First Post:
2022-02-15
Brief Title:
Anterior Quadratus Lumborum Block Versus Erector Spinae Plane Block After Elective Cesarean Section
Sponsor:
Kasr El Aini Hospital
Organization:
Kasr El Aini Hospital
Study Overview
Official Title:
The Analgesic Effect of Single Shot Anterior Quadratus Lumborum Block Versus Erector Spinae Plane Block After Elective Cesarean Section A Randomized Controlled Douple Blinded Trial
Status:
COMPLETED
Status Verified Date:
2022-07
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:
Cesarean section is the one of the most common surgical procedures Inadequate pain management is associated with increased morbidity costs and maternal dissatisfaction Furthermore effective postoperative pain management enables mothers to care for their newborn infants Systemic and neuraxial opioids are the cornerstone of postoperative pain management however opioids are associated with significant side effect such as respiratory depression urine retention constipation and itching To reduce the postoperative opioids requirement and subsequently their side effects multimodal regimen is advice including neuraxial anesthesia neuraxial morphine regular administration of non-opioids analgesia non-steroidal anti-inflammatory drugs and acetaminophen and planned use of opioid for breakthrough pain
The addition of peripheral nerve blocks to the multimodal analgesic plan was found to reduced postoperative opioids requirement in non-obstetric procedures
Quadratus lumborum QLB and erector spinae plane ESPB blocks are relatively new techniques for peripheral nerve block and showed promising results in managing pain after Cesarean delivery
There are several types of QLB that had been described Lateral QLB1 posterior QLB2 and anterior QLB3 quadratus lumborum blocks been studied in cesarean delivery and were found to reduce opioids requirement when compared against placebo Cadaver studies suggest that local anesthetic deposition at QLB1 diffuses mainly to the transversus abdominis muscle plane while at QLB2 and at QLB3 spread may occur into the thoracic paravertebral space providing additional visceral pain control
ESPB can provide both visceral and somatic analgesia due to anterior spread to the paravertebral space ESPB was found to reduce postoperative opioids requirement in comparison to transversus abdominis plane block and intrathecal morphine
To the best of our knowledge there is no published data comparing the analgesic effect of QLB3 anterior QL and ESPB after elective cesarean delivery
The addition of peripheral nerve blocks to the multimodal analgesic plan was found to reduced postoperative opioids requirement in non-obstetric procedures
Quadratus lumborum QLB and erector spinae plane ESPB blocks are relatively new techniques for peripheral nerve block and showed promising results in managing pain after Cesarean delivery
There are several types of QLB that had been described Lateral QLB1 posterior QLB2 and anterior QLB3 quadratus lumborum blocks been studied in cesarean delivery and were found to reduce opioids requirement when compared against placebo Cadaver studies suggest that local anesthetic deposition at QLB1 diffuses mainly to the transversus abdominis muscle plane while at QLB2 and at QLB3 spread may occur into the thoracic paravertebral space providing additional visceral pain control
ESPB can provide both visceral and somatic analgesia due to anterior spread to the paravertebral space ESPB was found to reduce postoperative opioids requirement in comparison to transversus abdominis plane block and intrathecal morphine
To the best of our knowledge there is no published data comparing the analgesic effect of QLB3 anterior QL and ESPB after elective cesarean delivery
Detailed Description:
Upon arrival to the operating room routine monitors electrocardiogram pulse oximetry and non-invasive blood pressure monitor will be applied intravenous line will be secured and pre-medication drugs will be delivered metoclopramide 10 mg and ranitidine 50 mg Lactated Ringers co-load will be rapidly infused at a rate of 15 mLKg-1 over 10 minutes
Spinal anesthesia will be achieved by injecting 20 to 23 mg hyperbaric bupivacaine 05 plus 25 mcg fentanyl in L3-L4 or L4-L5 interspace
The spinal block will be performed in the sitting position using a 25G spinal needle through midline approach The participant will be then positioned supine with left-lateral uterine tilt Pinprick was used for evaluation of block success 5 minutes after intrathecal injection Successful block was confirmed if sensory block level was at T4 at least
After skin closure and the covering of the wound with a dressing patients received intravenous paracetamol 1 g and ketorolac 30 mg
Spinal block height will be assessed at the end of surgery to ensure enough anesthesia at the site of block performance If the site of needle entry was not anesthetized a local infiltration with 2ml of 20 lidocaine will be injected prior to the block Patients will be blinded to block allocation using the surgical drapes to occlude their view The patient will be into the lateral position and the back will be prepared in an aseptic manner
after the end of the procedure the patients will receive their assigned intervention The blocks will be performed by experienced operator who will be informed of the patient group after patient positioning The patient and the assessor of the block will be blinded to the study group
Postoperative care All patients will receive parenteral paracetamol 1 g6hours and ketorolac 30 mg8hours postoperatively Pain assessments using numerical rate scale NRS will be performed at rest and during movement knee flexion at 05 1 2 4 6 18 24 h after leaving the operating room If NRS score is 3 intravenous titration of 2 mg morphine given slowly to be repeated after 30 minutes if pain persisted if other opioid given the morphine equivalent dose will be calculated from the opioid conversion chart
All scores will be assigned by each patient with the assistance of an anesthesiologist not responsible for the surgical intervention
Intravenous ondansetron 4 mg will be given to treat nausea or vomiting Complications nausea vomiting itching urine retention sedation Age weight height and body mass index duration of pregnancy parity and gravity
Spinal anesthesia will be achieved by injecting 20 to 23 mg hyperbaric bupivacaine 05 plus 25 mcg fentanyl in L3-L4 or L4-L5 interspace
The spinal block will be performed in the sitting position using a 25G spinal needle through midline approach The participant will be then positioned supine with left-lateral uterine tilt Pinprick was used for evaluation of block success 5 minutes after intrathecal injection Successful block was confirmed if sensory block level was at T4 at least
After skin closure and the covering of the wound with a dressing patients received intravenous paracetamol 1 g and ketorolac 30 mg
Spinal block height will be assessed at the end of surgery to ensure enough anesthesia at the site of block performance If the site of needle entry was not anesthetized a local infiltration with 2ml of 20 lidocaine will be injected prior to the block Patients will be blinded to block allocation using the surgical drapes to occlude their view The patient will be into the lateral position and the back will be prepared in an aseptic manner
after the end of the procedure the patients will receive their assigned intervention The blocks will be performed by experienced operator who will be informed of the patient group after patient positioning The patient and the assessor of the block will be blinded to the study group
Postoperative care All patients will receive parenteral paracetamol 1 g6hours and ketorolac 30 mg8hours postoperatively Pain assessments using numerical rate scale NRS will be performed at rest and during movement knee flexion at 05 1 2 4 6 18 24 h after leaving the operating room If NRS score is 3 intravenous titration of 2 mg morphine given slowly to be repeated after 30 minutes if pain persisted if other opioid given the morphine equivalent dose will be calculated from the opioid conversion chart
All scores will be assigned by each patient with the assistance of an anesthesiologist not responsible for the surgical intervention
Intravenous ondansetron 4 mg will be given to treat nausea or vomiting Complications nausea vomiting itching urine retention sedation Age weight height and body mass index duration of pregnancy parity and gravity
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