Postoperative PainNCT04552548
Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Analgesia in Children
A study testing regional nerve block in people with Postoperative Pain, run by Minia University at 1 site in Egypt.
Trial summary
The aim of the present study is to evaluate and compare the analgesic effect of ultrasound-guided Quadratus Lumborum Block with ultrasound-guided Transversus Abdominis plane block in pediatric Laparoscopic lower abdominal surgeries Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- regional nerve block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2019to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA I-II physical status patients
- Children scheduled for laparoscopic surgery
- Duration of Laparoscopic procedure not exceeding 90 minutes
Who cannot join
- Sensitivities to local anesthetics
- Significant renal, liver, or cardiac disease
- Surgery requiring an open procedure
- Participants refusing regional block
- Those having bleeding disorders, skin lesions or wounds at the site of proposed needle insertion, evidence of peritonitis, septicemia
- Children required emergency procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-Guided Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Analgesia in Children Undergoing Laparoscopic Surgery.
The aim of the present study is to evaluate and compare the analgesic effect of ultrasound-guided Quadratus Lumborum Block with ultrasound-guided Transversus Abdominis plane block in pediatric Laparoscopic lower abdominal surgeries
Read the detailed description
90 male and female patients aged from 1 to 7 years old from ASA class I to II undergoing elective laparoscopic lower abdominal surgery will be randomly divided into three equal groups of thirty patients each by using computer generated random table.
Technique of the study After insertion of venous access, all children received premedication in the form of atropine at a dose of 0.01-0.02 mg/kg. Perioperative monitoring included continuous ECG, pulse oximetry and non-invasive arterial blood pressure. Baseline reading of heart rate, mean arterial blood pressure was recorded after monitor attachment. General anesthesia will be induced using propofol 1.5-2.5 mg/kg over 20-30 sec. as tolerated, atracurium 0.5 mg/kg to facilitate endotracheal intubation and fentanyl 1 µg/kg. Anesthesia will be maintained using isoflurane (1 MAC) and atracurium 0.1 mg/kg supplements will be given to maintain muscle relaxation.
TAP block or quadratus lumborum block will be performed in all patients immediately after induction and before starting of surgery. patients will be allocated randomly into three equal groups , 30 patients in each as the following :-
Group C "Control group" will receive regular analgesics (1 µg /kg fentanyl with induction and 15mg/kg paracetamol before extubation).
Group TAP "TAP group" will receive bilateral TAP block using (0.5 ml/ kg bupivacaine 0.25%) in each side + regular analgesics.
Group QL"quadratus lumborum group" will receive bilateral quadratus lumborum block using (0.5 ml/ kg bupivacaine 0.25%) in each side + regular analgesics.
TAP block procedure
With the patient in the supine position, the site of the ultrasound and needle entry was sterilized. The TAP block will be performed laterally behind the midaxillary line between the iliac crest and the most inferior extent of the ribs. The plane between the internal oblique and transversus abdominis muscle located around the midaxillary line with the probe transverse to the abdomen. Anteriorly, the needle passes to come perpendicular to the ultrasound beam and placed between transversus and internal oblique posterior to the midaxillary line. Then, the local anesthetic will be injected. QL block prcedure
bilateral ultrasound guided transmuscular quadrates lumborum (TQL) block was given SONOSITE NANOMAX; the scanning probe was the linear 25N multifrequency 13-6 MHz transducer (L25x13-6 MHz linear array) made in USA. In lateral position, the side to be blocked was kept up and probe was placed in the midaxillary line in the transverse plane immediately above the iliac crest and then it was slided dorsally till the Shamrock sign was clearly identified. In "Shamrock sign" The quadratus lumborum (QL) muscle is seen as a superior leaf of the Shamrock at the apex of the transverse process (TP) of L4, erector spinae (ES) muscles make up the posterior leaf, psoas major (PM) muscle makes the anterior leaf and the transverse process (TP) represents the stem connecting the 3leaves. A 22-G 90-mm spinal needle was inserted from the posterior end of the probe and directed for the fascial plane between the QL and PM muscles through the QL muscle. Once needle was confirmed at correct location the drug was injected. Other side was also injected in similar manner. The parents were not aware of group allocation as the block was done after induction of anesthesia. An independent anesthesiologist conducted postoperative assessments and was not aware of group allocation
The surgical intervention was started 15 min after QL block. Pneumoperitoneum was maintained at a flow rate of 0.5 L/min and a pressure of 8-12 mm Hg with CO2 insufflation.
After completion of surgical procedure anesthesia was discontinued, muscle relaxant reversed using atropine 0.02 mg/kg and 0.05 mg/kg of prostigmine. Paracetamol infusion (15 mg/kg) will be given by intravenous infusion before extubation. After extubation transfer the children to PACU.
Postoperatively pain will be assessed using FLACC score (face, leg, activity, cry and consolability) as shown in the table below. Acetaminophine (perfalgan) 15 mg/kg IV will be given as rescue analgesia for patients if FLACC score >4.
Parameters will be assessed
- Preoperative and intraoperative measurements:
- Hemodynamic parameters: HR, MAP and SaO2 were recorded before and immediately after induction of anesthesia, at the time of puncture of the prop and then every 5 min intervals until the end of the operation.
- Analgesic requirement: all through the procedure (by measuring the analgesic need intra operative in the form of fentanyl 0.5 µg/kg) in case of increase in intraoperative mean arterial blood pressure or heart rate of more than 20% of baseline for longer than 5 minutes.
- Incidence of complications: in the form of hemodynamic instability, injury to the underlying structures, and hematoma formation as recorded under ultrasound guidance.
- Postoperative measurement:
- The number of patients who require rescue analgesia in the first 24 h. 2. Quality of analgesia: it will be assessed immediately postoperatively, every 30min in the PACU and then at 4, 6, 8, 10, 12, 18, and 24 h postoperatively using FLACC score.
- Time to the first analgesic requirement: Duration of analgesia was defined as the time interval from completion of local anesthetic administration till first need of rescue analgesic (FLACC>4) in the form of IV paracetamol 15mg/kg.
Each category is scored on the 0-2 scale, which results in a total score of 0-10. 0 Relaxed and comfortable 1-3 Mild discomfort Behaviour 0 1 2 Face No particular expression or smile
Occasional grimace or frown, withdrawn, disinterested
Frequent to constant quivering chin, clenched jow Legs Normal position or relaxed
Uneasy, restless, tense Kicking or legs drawn up Activity Lying quietly, normal position, moves easily
Squirming, shifting, back and forth, tense
Arched, rigid or jerking Cry No cry (awake or asleep)
Moans or whimpers; occasional complaint
Crying steadily, screams, sobs, frequent complaints Consolability Content, relaxed Reassured by touching, hugging or being talked to, distractible Difficult to console or comfort 4-6 Moderate pain 7-10 Severe discomfort or pain or both (Merkel, et al., 1997) 4. Total amount and the numbers of analgesic doses in 24h. 5. Hemodynamic data: HR, MAP and SaO2 were recorded up to 120 min.
- length of hospital stay and patients or parents satisfaction assessed on a 5point scale. 1-completely dissatisfied, 2-dissatisfied, 3-not satisfied nor dissatisfied, 4- satisfied 5-completely satisfied 7. Postoperative complication: including postoperative hypotention or bradycardia (decrease in MAP or HR by more than 20% of baseline value), postoperative nausea and vomiting (PONV).
- Conditions
- Postoperative Pain
- Being tested
- regional nerve block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regional nerve blockOther
Abdominal field blocks have been used in anesthesia for surgery involving the anterior abdominal wall with ultrasound-guided technique. TAP block is a regional anesthetic technique that blocks neural afferents of the anterolateral abdominal wall. Using anatomical landmark guidance or with the aid of ultrasound (US), local anesthetic is injected into the transversus abdominis fascial plane, where the nerves from T6 to L1 are located. Ultrasound-guided quadratus lumborum (QL) block is considered now as one of the novel truncal abdominal blocks, as it is effective in preventing somatic pain associated with upper and lower abdominal surgeries.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | the patients will receive regular analgesics (1 µg /kg fentanyl with induction and 15mg/kg paracetamol before extubation) |
| TAP group | Active comparator | the patients will receive bilateral TAP block using (0.5 ml/ kg bupivacaine 0.25%) in each side + regular analgesics. Receives: Other: regional nerve block |
| quadratus lumborum group | Active comparator | the patients will receive bilateral quadratus lumborum block using (0.5 ml/ kg bupivacaine 0.25%) in each side + regular analgesics. Receives: Other: regional nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of postoperative analgesia
Postoperative Pain scores as FLACC score (face, legs, activity, cry and consolability)
Measured: 24 hours after surgery
Secondary outcomes (2)
analgesic consumption
Total postoperative analgesic consumption : The total paracetamol (mg/kg)
Measured: 24 hours
duration of analgesia
Time to first demand of rescue analgesic: Duration of analgesia was defined as the time interval from completion of local anesthetic administration till first need of rescue analgesic (FLACC>4) in the form of IV paracetamol 15mg/kg.
Measured: 24 hours after block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start1 Oct 2019
- Primary completion1 Nov 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, haidy salah mansour, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04552548
- Sponsor's protocol ID
- 271:7/2019
- Status last verified
- Jul 2023
- First submitted
- 31 Aug 2020
- Last updated
- 1 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Analgesia in Children Undergoing Laparoscopic Surgery.
- ClinicalTrials.gov ID
- NCT04552548
- Acronym / sponsor ID
- 271:7/2019
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 17 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study is to evaluate and compare the analgesic effect of ultrasound-guided Quadratus Lumborum Block with ultrasound-guided Transversus Abdominis plane block in pediatric Laparoscopic lower abdominal surgeries
Detailed description
90 male and female patients aged from 1 to 7 years old from ASA class I to II undergoing elective laparoscopic lower abdominal surgery will be randomly divided into three equal groups of thirty patients each by using computer generated random table.
Technique of the study After insertion of venous access, all children received premedication in the form of atropine at a dose of 0.01-0.02 mg/kg. Perioperative monitoring included continuous ECG, pulse oximetry and non-invasive arterial blood pressure. Baseline reading of heart rate, mean arterial blood pressure was recorded after monitor attachment. General anesthesia will be induced using propofol 1.5-2.5 mg/kg over 20-30 sec. as tolerated, atracurium 0.5 mg/kg to facilitate endotracheal intubation and fentanyl 1 µg/kg. Anesthesia will be maintained using isoflurane (1 MAC) and atracurium 0.1 mg/kg supplements will be given to maintain muscle relaxation.
TAP block or quadratus lumborum block will be performed in all patients immediately after induction and before starting of surgery. patients will be allocated randomly into three equal groups , 30 patients in each as the following :-
Group C "Control group" will receive regular analgesics (1 µg /kg fentanyl with induction and 15mg/kg paracetamol before extubation).
Group TAP "TAP group" will receive bilateral TAP block using (0.5 ml/ kg bupivacaine 0.25%) in each side + regular analgesics.
Group QL"quadratus lumborum group" will receive bilateral quadratus lumborum block using (0.5 ml/ kg bupivacaine 0.25%) in each side + regular analgesics.
TAP block procedure
With the patient in the supine position, the site of the ultrasound and needle entry was sterilized. The TAP block will be performed laterally behind the midaxillary line between the iliac crest and the most inferior extent of the ribs. The plane between the internal oblique and transversus abdominis muscle located around the midaxillary line with the probe transverse to the abdomen. Anteriorly, the needle passes to come perpendicular to the ultrasound beam and placed between transversus and internal oblique posterior to the midaxillary line. Then, the local anesthetic will be injected. QL block prcedure
bilateral ultrasound guided transmuscular quadrates lumborum (TQL) block was given SONOSITE NANOMAX; the scanning probe was the linear 25N multifrequency 13-6 MHz transducer (L25x13-6 MHz linear array) made in USA. In lateral position, the side to be blocked was kept up and probe was placed in the midaxillary line in the transverse plane immediately above the iliac crest and then it was slided dorsally till the Shamrock sign was clearly identified. In "Shamrock sign" The quadratus lumborum (QL) muscle is seen as a superior leaf of the Shamrock at the apex of the transverse process (TP) of L4, erector spinae (ES) muscles make up the posterior leaf, psoas major (PM) muscle makes the anterior leaf and the transverse process (TP) represents the stem connecting the 3leaves. A 22-G 90-mm spinal needle was inserted from the posterior end of the probe and directed for the fascial plane between the QL and PM muscles through the QL muscle. Once needle was confirmed at correct location the drug was injected. Other side was also injected in similar manner. The parents were not aware of group allocation as the block was done after induction of anesthesia. An independent anesthesiologist conducted postoperative assessments and was not aware of group allocation
The surgical intervention was started 15 min after QL block. Pneumoperitoneum was maintained at a flow rate of 0.5 L/min and a pressure of 8-12 mm Hg with CO2 insufflation.
After completion of surgical procedure anesthesia was discontinued, muscle relaxant reversed using atropine 0.02 mg/kg and 0.05 mg/kg of prostigmine. Paracetamol infusion (15 mg/kg) will be given by intravenous infusion before extubation. After extubation transfer the children to PACU.
Postoperatively pain will be assessed using FLACC score (face, leg, activity, cry and consolability) as shown in the table below. Acetaminophine (perfalgan) 15 mg/kg IV will be given as rescue analgesia for patients if FLACC score >4.
Parameters will be assessed
- Preoperative and intraoperative measurements:
- Hemodynamic parameters: HR, MAP and SaO2 were recorded before and immediately after induction of anesthesia, at the time of puncture of the prop and then every 5 min intervals until the end of the operation.
- Analgesic requirement: all through the procedure (by measuring the analgesic need intra operative in the form of fentanyl 0.5 µg/kg) in case of increase in intraoperative mean arterial blood pressure or heart rate of more than 20% of baseline for longer than 5 minutes.
- Incidence of complications: in the form of hemodynamic instability, injury to the underlying structures, and hematoma formation as recorded under ultrasound guidance.
- Postoperative measurement:
- The number of patients who require rescue analgesia in the first 24 h. 2. Quality of analgesia: it will be assessed immediately postoperatively, every 30min in the PACU and then at 4, 6, 8, 10, 12, 18, and 24 h postoperatively using FLACC score.
- Time to the first analgesic requirement: Duration of analgesia was defined as the time interval from completion of local anesthetic administration till first need of rescue analgesic (FLACC>4) in the form of IV paracetamol 15mg/kg.
Each category is scored on the 0-2 scale, which results in a total score of 0-10. 0 Relaxed and comfortable 1-3 Mild discomfort Behaviour 0 1 2 Face No particular expression or smile
Occasional grimace or frown, withdrawn, disinterested
Frequent to constant quivering chin, clenched jow Legs Normal position or relaxed
Uneasy, restless, tense Kicking or legs drawn up Activity Lying quietly, normal position, moves easily
Squirming, shifting, back and forth, tense
Arched, rigid or jerking Cry No cry (awake or asleep)
Moans or whimpers; occasional complaint
Crying steadily, screams, sobs, frequent complaints Consolability Content, relaxed Reassured by touching, hugging or being talked to, distractible Difficult to console or comfort 4-6 Moderate pain 7-10 Severe discomfort or pain or both (Merkel, et al., 1997) 4. Total amount and the numbers of analgesic doses in 24h. 5. Hemodynamic data: HR, MAP and SaO2 were recorded up to 120 min.
- length of hospital stay and patients or parents satisfaction assessed on a 5point scale. 1-completely dissatisfied, 2-dissatisfied, 3-not satisfied nor dissatisfied, 4- satisfied 5-completely satisfied 7. Postoperative complication: including postoperative hypotention or bradycardia (decrease in MAP or HR by more than 20% of baseline value), postoperative nausea and vomiting (PONV).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –the patients will receive regular analgesics (1 µg /kg fentanyl with induction and 15mg/kg paracetamol before extubation) |
| TAP group | Active comparator | Other: regional nerve blockthe patients will receive bilateral TAP block using (0.5 ml/ kg bupivacaine 0.25%) in each side + regular analgesics. |
| quadratus lumborum group | Active comparator | Other: regional nerve blockthe patients will receive bilateral quadratus lumborum block using (0.5 ml/ kg bupivacaine 0.25%) in each side + regular analgesics. |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA I-II physical status patients
- Children scheduled for laparoscopic surgery
- Duration of Laparoscopic procedure not exceeding 90 minutes
Key exclusion criteria (6 listed)
- Sensitivities to local anesthetics
- Significant renal, liver, or cardiac disease
- Surgery requiring an open procedure
- Participants refusing regional block
- Those having bleeding disorders, skin lesions or wounds at the site of proposed needle insertion, evidence of peritonitis, septicemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| regional nerve blockAbdominal field blocks have been used in anesthesia for surgery involving the anterior abdominal wall with ultrasound-guided technique. TAP block is a regional anesthetic technique that blocks neural afferents of the anterolateral abdominal wall. Using anatomical landmark guidance or with the aid of ultrasound (US), local anesthetic is injected into the transversus abdominis fascial plane, where the nerves from T6 to L1 are located. Ultrasound-guided quadratus lumborum (QL) block is considered now as one of the novel truncal abdominal blocks, as it is effective in preventing somatic pain associated with upper and lower abdominal surgeries. | Other | TAP group, quadratus lumborum group |
Primary outcome
quality of postoperative analgesia
Time frame: 24 hours after surgery
Postoperative Pain scores as FLACC score (face, legs, activity, cry and consolability)
2 secondary outcomes
analgesic consumption
Time frame: 24 hours
duration of analgesia
Time frame: 24 hours after block
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing regional nerve block in people with Postoperative Pain, run by Minia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of postoperative analgesia (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.