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Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Children Undergoing Laparoscopic Appendicectomy
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Children Appendicitis | Procedure: QLB Procedure: TAP block | Not Applicable |
Recently, the laparoscopic technique has been successfully used for many pediatric surgical cases. The laparoscopic appendicectomy is favored over the traditional open method, as it has a lower incidence of postoperative surgical complications and faster recovery to normal daily activities. Although it is considered as minimally invasive surgery, patients may require hospitalization for over 24 hours following laparoscopic appendicectomy, and postoperative pain which is caused by the surgical wound and visceroperitonitic pain as a result of peritoneal inflammation and infection, may extend the length of hospital stay.
Regional anesthesia techniques are commonly enhanced for pain management in pediatric surgical procedure as they decrease parenteral opioid requirements and improve patient-parent satisfaction [6].
The Transversus Abdominis Plane (TAP) block was first described in 2004 by McDonnell et al. using anatomical landmark guidance, and ultrasound-guided technique was later popularized by Hebbard et al. TAP block is aiming to block sensory nerves that course between the transversus abdominis and internal oblique muscles and supply the anterior abdominal wall, where local anesthetic is injected into the transversus abdominis fascial plane. Many clinical studies have reported the efficacy of TAP block in providing adequate postoperative analgesia for lower abdominal surgery.
Quadratus Lumborum block was initially described by R.Blanco as an abstract at the annual European Society of Regional Anaesthesia (ESRA) congress in 2007, where the local anesthetic (LA) was injected in the anterolateral aspect of the QL muscle (type 1 QL block). Later, J. Børglum used posterior transmuscular approach by detecting Shamrock sign and injecting the LA in the anterior aspect of the QL (type 3 QL block). Recently, R. Blanco described another approach by injecting the LA in the posterior aspect of the QL muscle (type 2 QL block), which may be easier and safer as the LA is injected in a more superficial plane, so the risk of intra-abdominal complications and lumbar plexus injuries is reduced. And finally the intramuscular QL block (type 4 QL block), the local anesthetic is injected directly into the QL muscle.
We hypothesize that ultrasound-guided QL block will be more superior than or equal to TAP block in providing postoperative analgesia for children undergoing laparoscopic appendicectomy.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 34 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | 34 patients randomly allocated into two equal groups 17 patients in each group: Quadratus Lumborum Block" QLB group": ultrasound-guided QLB type 2 with 0.5ml/kg of 0.25% levobupivacaine local anesthetic was done to patients. and Transversus Abdominis Plane Block group (TAP block): ultrasound-guided TAP block with 0.5ml/kg of 0.25% levobupivacaine local anesthetic was done to patients. |
| Masking: | Double (Participant, Care Provider) |
| Masking Description: | the participants were masked for the type of regional anesthesia given the care provider was blind to the type of the regional block given to the patient and he was asked to assess the visual analogue scale score, first time of rescue analgesia, the total dose of rescue analgesia given and postoperative side effects. |
| Primary Purpose: | Supportive Care |
| Official Title: | Ultrasound-guided Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Children Undergoing Laparoscopic Appendicectomy: A Randomized Clinical Study |
| Actual Study Start Date : | October 1, 2018 |
| Actual Primary Completion Date : | March 1, 2019 |
| Actual Study Completion Date : | July 1, 2019 |
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: QLB group, Quadratus Lumborum Block group
the patient placed in the lateral decubitus position, the low-frequency convex probe of Sonosite M Turbo ultrasonography was placed in the anterior axillary line midway between subcostal margin and iliac crest to identify the abdominal muscle layers, then the probe was moved to the posterior axillary line to visualize the quadratus lumborum muscle attached to the transverse process of the L4, With the psoas major muscle placed anteriorly, the erector spinae muscle posteriorly, a 22-gauge, 80 mm needle was inserted in-plane into the posterior aspect of QL muscle (between quadratus lumborum and erector spinae muscle), and then 0.5ml/kg of 0.25% levobupivacaine local anesthetic was injected behind the muscle as a bolus dose. The block was performed bilaterally.
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Procedure: QLB
QLB type 2 approach
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Active Comparator: TAP block group,Transversus Abdominis Plane Block group
patient placed in the supine position, a linear multifrequency 6-13 MHz probe of Sonosite M Turbo ultrasonography was placed posterior to the midaxillary line at the midpoint between the inferior costal margin and the iliac crest, a 22-gauge, 50 mm needle was placed using an in-plane technique between the internal oblique and transversus abdominis muscle then local anesthetic was injected in a bolus dose 0.5ml/kg of 0.25% levobupivacaine, the block was done bilaterally.. after ultrasound Identification of the plane between the internal oblique and transversus abdominis muscle,
|
Procedure: TAP block
classic TAP block approach
|
- changes in intraoperative mean arterial blood pressure (MAP) values [ Time Frame: at base line (To), 3 minutes(min) after induction of general anesthesia, 10 min after intubation (immediately before performing the block (T1)), 15 min after performing the block (T2),and intraoperative values every 15 min till the end of surgery(T3) ](mm Hg)
- changes in intraoperative heart rate (HR) values [ Time Frame: at base line (To), 3 minutes(min) after induction of general anesthesia, 10 min after intubation (immediately before performing the block (T1)), 15 min after performing the block (T2),and intraoperative values every 15 min till the end of surgery(T3) ](beats/minute)
- changes in the degree of pain perception by patient [ Time Frame: Patients were assessed in the immediate post operative period and then at 2 hour(h), 4h, 6h , 8h , 12 h, 18 h and at 24 hours postoperative for the quality of analgesia ]measured by visual analogue scale(VAS), The patient was trained to report the level of pain on VAS scale from 0 to 10 (where 0 indicates no pain and 10 indicates the most severe pain).
- total intraoperative fentanyl consumption [ Time Frame: during the time of the surgical procedure ]measured by μg /kg
- 1st time of rescue analgesics [ Time Frame: during the first postoperative 24 hours ]minute
- total amount of rescue analgesic consumed [ Time Frame: in the first postoperative 24 hours ]mg/kg
- post operative nausea and vomiting [ Time Frame: in the first postoperative 24 hours ]by number of patients complained of these side effects
- degree of patient and parent satisfaction [ Time Frame: at the end of the first postoperative 24 hours ]5-point scale assessment (satisfied or completely satisfied, not satisfied nor dissatisfied, dissatisfied, completely dissatisfied)
| Ages Eligible for Study: | 7 Years to 12 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- parent and patient acceptance,
- Children 7-12 years old,
- 20-35kg bodyweight,
-
ASA I-II,
- and scheduled for Laparoscopic appendicectomy
Exclusion Criteria:
- Patients refusing regional anesthesia,
- those with bleeding disorders,
- skin lesion at the needle insertion site,
- sepsis,
- liver disease,
- peritonitis,
- and emergency cases
| Egypt | |
| Faculty of medicine, zagazig university | |
| Zagazig, Elsharqya, Egypt, 44519 | |
| Principal Investigator: | Shereen E Abd Ellatif, MD | Anesthesia and Surgical Intensive Care Department, Faculty of medicine, Zagazig University | |
| Study Director: | Fatma M Ahmed, MD | Anesthesia and Surgical Intensive Care Department, Faculty of medicine, Zagazig University |
| Tracking Information | |||||||||||||||||||
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| First Submitted Date ICMJE | July 17, 2019 | ||||||||||||||||||
| First Posted Date ICMJE | July 24, 2019 | ||||||||||||||||||
| Last Update Posted Date | August 7, 2020 | ||||||||||||||||||
| Actual Study Start Date ICMJE | October 1, 2018 | ||||||||||||||||||
| Actual Primary Completion Date | March 1, 2019 (Final data collection date for primary outcome measure) | ||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | |||||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||
| Descriptive Information | |||||||||||||||||||
| Brief Title ICMJE | Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Children Undergoing Laparoscopic Appendicectomy | ||||||||||||||||||
| Official Title ICMJE | Ultrasound-guided Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Children Undergoing Laparoscopic Appendicectomy: A Randomized Clinical Study | ||||||||||||||||||
| Brief Summary | QL block has been recently described for chronic pain following abdominal hernia repair, and for postoperative analgesia following abdominal surgery as it leads to complete pain relief in the dermatomal area from (T6 - L1). Theoretically, QL blocks might give better and longer-lasting analgesia compared to the US-guided anterior TAP block due to a spread to the thoracic paravertebral space and sympathetic nerves in the thoracolumbar fascia, so visceral afferent pathways to the medulla can be blocked. | ||||||||||||||||||
| Detailed Description |
Recently, the laparoscopic technique has been successfully used for many pediatric surgical cases. The laparoscopic appendicectomy is favored over the traditional open method, as it has a lower incidence of postoperative surgical complications and faster recovery to normal daily activities. Although it is considered as minimally invasive surgery, patients may require hospitalization for over 24 hours following laparoscopic appendicectomy, and postoperative pain which is caused by the surgical wound and visceroperitonitic pain as a result of peritoneal inflammation and infection, may extend the length of hospital stay. Regional anesthesia techniques are commonly enhanced for pain management in pediatric surgical procedure as they decrease parenteral opioid requirements and improve patient-parent satisfaction [6]. The Transversus Abdominis Plane (TAP) block was first described in 2004 by McDonnell et al. using anatomical landmark guidance, and ultrasound-guided technique was later popularized by Hebbard et al. TAP block is aiming to block sensory nerves that course between the transversus abdominis and internal oblique muscles and supply the anterior abdominal wall, where local anesthetic is injected into the transversus abdominis fascial plane. Many clinical studies have reported the efficacy of TAP block in providing adequate postoperative analgesia for lower abdominal surgery. Quadratus Lumborum block was initially described by R.Blanco as an abstract at the annual European Society of Regional Anaesthesia (ESRA) congress in 2007, where the local anesthetic (LA) was injected in the anterolateral aspect of the QL muscle (type 1 QL block). Later, J. Børglum used posterior transmuscular approach by detecting Shamrock sign and injecting the LA in the anterior aspect of the QL (type 3 QL block). Recently, R. Blanco described another approach by injecting the LA in the posterior aspect of the QL muscle (type 2 QL block), which may be easier and safer as the LA is injected in a more superficial plane, so the risk of intra-abdominal complications and lumbar plexus injuries is reduced. And finally the intramuscular QL block (type 4 QL block), the local anesthetic is injected directly into the QL muscle. We hypothesize that ultrasound-guided QL block will be more superior than or equal to TAP block in providing postoperative analgesia for children undergoing laparoscopic appendicectomy. |
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| Study Type ICMJE | Interventional | ||||||||||||||||||
| Study Phase ICMJE | Not Applicable | ||||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: 34 patients randomly allocated into two equal groups 17 patients in each group: Quadratus Lumborum Block" QLB group": ultrasound-guided QLB type 2 with 0.5ml/kg of 0.25% levobupivacaine local anesthetic was done to patients. and Transversus Abdominis Plane Block group (TAP block): ultrasound-guided TAP block with 0.5ml/kg of 0.25% levobupivacaine local anesthetic was done to patients. Masking Description: the participants were masked for the type of regional anesthesia given the care provider was blind to the type of the regional block given to the patient and he was asked to assess the visual analogue scale score, first time of rescue analgesia, the total dose of rescue analgesia given and postoperative side effects. Primary Purpose: Supportive Care
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||||||||
| Actual Enrollment ICMJE |
34 | ||||||||||||||||||
| Original Actual Enrollment ICMJE | Same as current | ||||||||||||||||||
| Actual Study Completion Date ICMJE | July 1, 2019 | ||||||||||||||||||
| Actual Primary Completion Date | March 1, 2019 (Final data collection date for primary outcome measure) | ||||||||||||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 7 Years to 12 Years (Child) | ||||||||||||||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||
| Listed Location Countries ICMJE | Egypt | ||||||||||||||||||
| Removed Location Countries | |||||||||||||||||||
| Administrative Information | |||||||||||||||||||
| NCT Number ICMJE | NCT04031196 | ||||||||||||||||||
| Other Study ID Numbers ICMJE | 5504-16-9-2018 | ||||||||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Shereen Elsayed Abd Ellatif, Zagazig University | ||||||||||||||||||
| Study Sponsor ICMJE | Zagazig University | ||||||||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||||||||
| Investigators ICMJE |
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| PRS Account | Zagazig University | ||||||||||||||||||
| Verification Date | August 2020 | ||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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