Abdominal PainNCT04553991
Lateral Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Laparoscopic Surgery
A study testing Ultrasound guided QL block and Ultrasound guided TAP block in people with Abdominal Pain, run by Fayoum University Hospital at 1 site in Egypt.
Trial summary
The transversus abdominis plane (TAP) block is an already established technique and is considered now as an efficient part of the multimodal pain management approach for abdominal surgical procedures. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Abdominal Pain
- What is being tested?
- Ultrasound guided QL block and Ultrasound guided TAP block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2019to 1 May 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients scheduled for elective laparoscopic abdominal surgeries (inguinal hernia repair-missed IUCD extraction-appendectomy-ovarian vein ligation)
- Patient aged 18-60 years
- American Society of Anesthesiologists Physical Status I or II.
Who cannot join
- Patient refusal
- Body mass index (BMI) > 40 kilogram/square meter
- Contraindication to regional anesthesia (coagulopathy, allergy to local anesthetic, sever thrombocytopenia or infection at puncture site)
- Sepsis
- Chronic pain condition requiring the intake of opioids at home
- Any significant neurological, cardiovascular or respiratory disease.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Fayoum University hospital
El Fayoum Qesm, Fayoum Governorate, 63514
About this study
Official title: Analgesic Effect of Ultrasound-Guided Bilateral Quadratus Lumborum Block (Lateral Approach) Versus Bilateral Transversus Abdominis Plane Block With General Anesthesia in Laparoscopic Abdominal Surgery (Randomized Controlled Clinical Trial)
The transversus abdominis plane (TAP) block is an already established technique and is considered now as an efficient part of the multimodal pain management approach for abdominal surgical procedures. The quadratus lumborum block (QLB) is a recently described regional block that was first described by Blanco et al , which has been reported to provide an effective analgesia for upper and lower abdominal surgeries. The aim of this study is to compare the analgesic efficacy of TAP block and QLB 1 after laparoscopic abdominal surgery regarding opioid consumption, duration of analgesia and visual analog score.
This prospective randomized controlled observer-blinded study compared between the analgesic efficacy between TAP block (n=25) versus QL block (n=25) in patients aged (18-60) years of American society of anesthesiologists physical status class I \& II scheduled for elective laparoscopic abdominal surgical procedures. The primary outcome was the cumulative morphine consumption at first 24 hours postoperatively. Secondary outcomes included VAS scores, first analgesic requirements and any postoperative complications
Read the detailed description
This prospective randomized, observer-blinded paralleled groups study was conducted following the tents of the Declaration of Helsinki. This study was approved by the local institutional ethics committee and local institutional review board of Fayoum university hospital and written informed consent was obtained from 50 adult patients scheduled for elective laparoscopic abdominal surgical procedures (inguinal hernia repair-missed IUCD extraction-appendectomy-ovarian vein ligation) between July 2019 and February 2020.
Patients were randomly allocated into two groups (QLB group n=25 and TAPB group n=25) using computer generated random numbers kept in separate opaque envelopes that were opened by the study investigator just before the block. The patient and the data collector were unaware of the group allocation till the end of the study.
Pre-operative assessment (History, examination and investigations) was done (according to the local protocol designed to evaluate the patients). Demographic characteristics: age, weight, height and BMI were recorded in preoperative assessment of patients. All patients received 150 mg Ranitidine oral tablet at night and on the morning just before the operation as a premedication. Before surgery, the participants received education about the VAS pain score (0-10) (where 0 = no pain and 10 = worst comprehensible pain) and the details of the nerve block procedures. After a 6 hrs fasting, the patients were taken to the operation theatre.
Upon arrival to the operating room standard monitors (Pulse oximeter, noninvasive blood pressure monitoring, capnography and electrocardiogram) were applied and continued all over the operation, an 18 gauge peripheral intravenous (IV) cannula was inserted, IV midazolam 0.03 mgkg-1, metoclopramide 10 mg, and ceftriaxone 1 gm were administered to all patients as premedication then pre-oxygenation with O2 100% for at least 3 min then induction of anesthesia was done with fentanyl 1μgkg-1, propofol 1.5-2 mgkg-1 and atracurium 0.5 mgkg-1. Anesthesia was maintained by volume controlled ventilation (VCV) tidal volume 6-8 mlkg-1 with oxygen and air (50:50) with target of EtCO2≈ 35-40 mmHg, isoflurane 1:1.5 % volume concentration and atracurium 0.1 mgkg-1 every 20-30 minutes.
The study solution was prepared in two syringes each contained 20 ml of bupivacaine 0.25%. By the end of surgery and before recovery from general anesthesia, either blocks were done using a high-frequency ultrasound probe Active Array L12-4 (8-13MHz) of an ultrasound machine (Philips clear vue350, Philips healthcare, Andover MA01810, USA) and a 22-gauge, 50 mm echogenic needle (Stimuplex D; B Braun, Germany).
For the ultrasound-guided quadratus lumborum block group, the patient was placed in lateral position and skin sterilization was done with povidone iodine. Then a high frequency linear probe was placed above the iliac crest to recognize the three layers of the abdominal wall muscles. Transversus abdominis was traced posteriorly until the transversus aponeurosis appeared, then the probe tilted slightly caudal to enhance the appearance of transversus aponeurosis. QL was identified medial to the aponeurosis of transversus abdominis muscle. Then the needle was inserted from supero-anterior to postero-inferior and advanced using in plane technique till the needle tip reached the anterolateral border of the QL at its junction with transversalis fascia. After negative aspiration (to exclude intravascular injection), the correct needle position was confirmed by hydrodissection using 1mL of normal saline. Then 20 mL of 0.25% bupivacaine was applied. The same technique was performed on the other side.
For the ultrasound-guided TAP block, skin sterilization was done with povidone iodine. The probe was placed in the mid-axillary line above the level of the anterior superior iliac spine, then slided cranially till the three abdominal wall muscles identified (External oblique muscle (EAO), internal oblique muscle (IOM) and transverse abdominis muscle (TAM)). The needle was advanced using in-plane technique till it reached the transvers abdominis plane between the IOM and TAM, the correct needle position was proved by hydrodissection using 1 mL of normal saline. An injection of 20 mL of 0.25% bupivacaine was applied. The same technique was performed on the other side.
After performing the block anesthesia was discontinued and tracheal extubation was done once the patient fulfilled the extubation criteria. Patients were transferred to post-anesthetic care unit (PACU), where they were discharged from the PACU after a modified Aldrete score≥9. Visual analogue scale (VAS) was used to assess postoperative pain. All patients received analgesics according to the local institutional protocol as following (paracetamol 1gm IV infusion/8 hrs and ketorolac 30 mg IM/12 hrs.). A postoperative rescue analgesia with morphine sulfate IV was given to patients with VAS >4 at a bolus dose of 3 mg increments with a maximum dose of 15mg per 4 hours or 45mg per 24 hours.
Sample size was estimated using G*Power© software version 3.1.9.2 (Institute of experimental psychology, Heinrich Heine University, Dusseldorf, Germany)149 with total opioid consumption among the two groups as the main primary outcome. Previous similar researches150 demonstrated that the effect size between the two groups was expected to be large of 1.12 and it calculated that 42 patients (21 patients per group) would provide to achieve a power of 95% with type I error rate of 0.05. However, we assigned 50 patients (25 patients per group) to compensate for data loss. The collected data were organized, tabulated and statistically analyzed using SPSS software statistical computer package version 22 (SPSS Inc, USA). Data were tested for normality using shapiro-wilks test. Numerical variables such as age, body weight, height and BMI were normally distributed and were described as mean ± standard deviation (SD). An independent t-test was used to compare the mean values of the two groups. Other variables were not normally distributed and were presented as median and interquartile range (IQR); Mann-Whitney U test was used as a test of significance. The time-to-event variable (time to analgesic request) was evaluated using the Kaplan-Meier method, and the logrank test was used to compare the groups. Qualitative data were presented as numbers and percentages, and the chi-squared test was used to determine significance. A two-sided P-value of <0.05 was considered statistically significant.
- Conditions
- Abdominal Pain
- Being tested
- Ultrasound guided QL block, Ultrasound guided TAP block
- Keywords
- laparoscopy, QL block, TAP block
- Medical subject headings
- Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided QL blockProcedure or surgery
20 mL of 0.25% bupivacaine was applied bilaterally at the anterolateral border of the QL at its junction with transversalis fascia
Ultrasound guided TAP blockProcedure or surgery
20 mL of 0.25% bupivacaine was applied bilaterally in the TAP
| Study group | Role | What they receive |
|---|---|---|
| QL block group | Active comparator | For the ultrasound-guided quadratus lumborum block group, the patient was placed in lateral position . QL was identified medial to the aponeurosis of transversus abdominis muscle. Then the needle was inserted from supero-anterior to postero-inferior and advanced using in plane technique till the needle tip reached the anterolateral border of the QL at its junction with transversalis fascia.An injection of 20 mL of 0.25% bupivacaine was applied bilaterally Receives: Procedure: Ultrasound guided QL block |
| TAP block group | Active comparator | For the ultrasound-guided TAP block,The probe was placed in the mid-axillary line above the level of the anterior superior iliac spine, then slided cranially till the three abdominal wall muscles identified (External oblique muscle (EAO), internal oblique muscle (IOM) and transverse abdominis muscle (TAM)). The needle was advanced using in-plane technique till it reached the transvers abdominis plane. An injection of 20 mL of 0.25% bupivacaine was applied bilaterally Receives: Procedure: Ultrasound guided TAP block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total morphine consumption at first 24 hours postoperatively
amount of morphine used in milligram after each block
Measured: 24 hours postoperatively
Secondary outcomes (19)
Postoperative pain, assessed using visual analog scale (VAS) score at 30 min postoperatively.
from 0 to 10 degrees
Measured: 30 minutes postoperatively
Postoperative pain, assessed using visual analog scale (VAS) score at 2 h postoperatively.
from 0 to 10 degrees
Measured: 2 hours postoperatively
Postoperative pain, assessed using visual analog scale (VAS) score at 4 h postoperatively.
from 0 to 10 degrees
Measured: 4 hours postoperatively
Postoperative pain, assessed using visual analog scale (VAS) score at 6 h postoperatively.
from 0 to 10 degrees
Measured: 6 hours postoperatively
Postoperative pain, assessed using visual analog scale (VAS) score at 12 h postoperatively.
from 0 to 10 degrees
Measured: 12 hours postoperatively
Postoperative pain, assessed using visual analog scale (VAS) score at 24 h postoperatively.
from 0 to 10 degrees
Measured: 24 hours postoperatively
Time to the first analgesic request
defined as the time interval elapsed between recovery and the first dose of morphine given.
Measured: 24 hours postoperatively
frequency of patients required postoperative opioid.
in numbers
Measured: First 24 hours postoperatively
incidence of postoperative nausea and vomiting
Any postoperative nausea or vomiting related to morphine consumption
Measured: First 24 hours postoperatively
incidence of postoperative pruritus
Any postoperative pruritus related to morphine consumption
Measured: First 24 hours postoperatively
incidence of postoperative sedation at 30 min postoperatively
sedation was assessed with a five-point sedation scale
Measured: at 30 minutes postoperatively
incidence of postoperative sedation at 2 h postoperatively
sedation was assessed with a five-point sedation scale
Measured: at 2 hours postoperatively
incidence of postoperative sedation at 6 h postoperatively
sedation was assessed with a five-point sedation scale
Measured: at 6 hours postoperatively
incidence of postoperative sedation at 12 h postoperatively
sedation was assessed with a five-point sedation scale
Measured: at 12 hours postoperatively
incidence of postoperative sedation at 24 h postoperatively
sedation was assessed with a five-point sedation scale
Measured: at 24 hours postoperatively
incidence of local anesthetic systemic toxicity
any observed local anesthetic systemic toxicity manifestations including CNS or CVS manifestations
Measured: in the first 24 hours postoperatively
incidence of vascular injury
incidence of vascular injury after each block
Measured: in the first 24 hours postoperatively
incidence of local hematoma
incidence of local hematoma at injection site after each block
Measured: in the first 24 hours postoperatively
incidence of visceral injury
incidence of visceral injury after each block
Measured: in the first 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start1 Jul 2019
- Primary completion1 Feb 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Abdominal PainStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed abdelaleem, Fayoum University Hospital
- Investigators
- Maged L boules, MD, Study chair, Faculty of medicine, Fayoum university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553991
- Sponsor's protocol ID
- M421
- Status last verified
- Sep 2020
- First submitted
- 5 Sep 2020
- Last updated
- 18 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kumar GD, Gnanasekar N, Kurhekar P, Prasad TK. A Comparative Study of Transversus Abdominis Plane Block versus Quadratus Lumborum Block for Postoperative Analgesia following Lower Abdominal Surgeries: A Prospective Double-blinded Study. Anesth Essays Res. 2018 Oct-Dec;12(4):919-923. doi: 10.4103/aer.AER_158_18.
PubMed 30662131Okmen K, Metin Okmen B, Topal S. Ultrasound-guided posterior quadratus lumborum block for postoperative pain after laparoscopic cholecystectomy: A randomized controlled double blind study. J Clin Anesth. 2018 Sep;49:112-117. doi: 10.1016/j.jclinane.2018.06.027. Epub 2018 Jun 18.
PubMed 29929169Fargaly OS, Boules ML, Hamed MA, Aleem Abbas MA, Shawky MA. Lateral Quadratus Lumborum Block versus Transversus Abdominis Plane Block in Laparoscopic Surgery: A Randomized Controlled Study. Anesthesiol Res Pract. 2022 Mar 28;2022:9201795. doi: 10.1155/2022/9201795. eCollection 2022.
PubMed 35386840
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Ultrasound-Guided Bilateral Quadratus Lumborum Block (Lateral Approach) Versus Bilateral Transversus Abdominis Plane Block With General Anesthesia in Laparoscopic Abdominal Surgery (Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT04553991
- Acronym / sponsor ID
- M421
- Conditions
- Abdominal Pain
- Keywords
- laparoscopy, QL block, TAP block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 18 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 transversus abdominis plane (TAP) block is an already established technique and is considered now as an efficient part of the multimodal pain management approach for abdominal surgical procedures. The quadratus lumborum block (QLB) is a recently described regional block that was first described by Blanco et al , which has been reported to provide an effective analgesia for upper and lower abdominal surgeries. The aim of this study is to compare the analgesic efficacy of TAP block and QLB 1 after laparoscopic abdominal surgery regarding opioid consumption, duration of analgesia and visual analog score.
This prospective randomized controlled observer-blinded study compared between the analgesic efficacy between TAP block (n=25) versus QL block (n=25) in patients aged (18-60) years of American society of anesthesiologists physical status class I \& II scheduled for elective laparoscopic abdominal surgical procedures. The primary outcome was the cumulative morphine consumption at first 24 hours postoperatively. Secondary outcomes included VAS scores, first analgesic requirements and any postoperative complications
Detailed description
This prospective randomized, observer-blinded paralleled groups study was conducted following the tents of the Declaration of Helsinki. This study was approved by the local institutional ethics committee and local institutional review board of Fayoum university hospital and written informed consent was obtained from 50 adult patients scheduled for elective laparoscopic abdominal surgical procedures (inguinal hernia repair-missed IUCD extraction-appendectomy-ovarian vein ligation) between July 2019 and February 2020.
Patients were randomly allocated into two groups (QLB group n=25 and TAPB group n=25) using computer generated random numbers kept in separate opaque envelopes that were opened by the study investigator just before the block. The patient and the data collector were unaware of the group allocation till the end of the study.
Pre-operative assessment (History, examination and investigations) was done (according to the local protocol designed to evaluate the patients). Demographic characteristics: age, weight, height and BMI were recorded in preoperative assessment of patients. All patients received 150 mg Ranitidine oral tablet at night and on the morning just before the operation as a premedication. Before surgery, the participants received education about the VAS pain score (0-10) (where 0 = no pain and 10 = worst comprehensible pain) and the details of the nerve block procedures. After a 6 hrs fasting, the patients were taken to the operation theatre.
Upon arrival to the operating room standard monitors (Pulse oximeter, noninvasive blood pressure monitoring, capnography and electrocardiogram) were applied and continued all over the operation, an 18 gauge peripheral intravenous (IV) cannula was inserted, IV midazolam 0.03 mgkg-1, metoclopramide 10 mg, and ceftriaxone 1 gm were administered to all patients as premedication then pre-oxygenation with O2 100% for at least 3 min then induction of anesthesia was done with fentanyl 1μgkg-1, propofol 1.5-2 mgkg-1 and atracurium 0.5 mgkg-1. Anesthesia was maintained by volume controlled ventilation (VCV) tidal volume 6-8 mlkg-1 with oxygen and air (50:50) with target of EtCO2≈ 35-40 mmHg, isoflurane 1:1.5 % volume concentration and atracurium 0.1 mgkg-1 every 20-30 minutes.
The study solution was prepared in two syringes each contained 20 ml of bupivacaine 0.25%. By the end of surgery and before recovery from general anesthesia, either blocks were done using a high-frequency ultrasound probe Active Array L12-4 (8-13MHz) of an ultrasound machine (Philips clear vue350, Philips healthcare, Andover MA01810, USA) and a 22-gauge, 50 mm echogenic needle (Stimuplex D; B Braun, Germany).
For the ultrasound-guided quadratus lumborum block group, the patient was placed in lateral position and skin sterilization was done with povidone iodine. Then a high frequency linear probe was placed above the iliac crest to recognize the three layers of the abdominal wall muscles. Transversus abdominis was traced posteriorly until the transversus aponeurosis appeared, then the probe tilted slightly caudal to enhance the appearance of transversus aponeurosis. QL was identified medial to the aponeurosis of transversus abdominis muscle. Then the needle was inserted from supero-anterior to postero-inferior and advanced using in plane technique till the needle tip reached the anterolateral border of the QL at its junction with transversalis fascia. After negative aspiration (to exclude intravascular injection), the correct needle position was confirmed by hydrodissection using 1mL of normal saline. Then 20 mL of 0.25% bupivacaine was applied. The same technique was performed on the other side.
For the ultrasound-guided TAP block, skin sterilization was done with povidone iodine. The probe was placed in the mid-axillary line above the level of the anterior superior iliac spine, then slided cranially till the three abdominal wall muscles identified (External oblique muscle (EAO), internal oblique muscle (IOM) and transverse abdominis muscle (TAM)). The needle was advanced using in-plane technique till it reached the transvers abdominis plane between the IOM and TAM, the correct needle position was proved by hydrodissection using 1 mL of normal saline. An injection of 20 mL of 0.25% bupivacaine was applied. The same technique was performed on the other side.
After performing the block anesthesia was discontinued and tracheal extubation was done once the patient fulfilled the extubation criteria. Patients were transferred to post-anesthetic care unit (PACU), where they were discharged from the PACU after a modified Aldrete score≥9. Visual analogue scale (VAS) was used to assess postoperative pain. All patients received analgesics according to the local institutional protocol as following (paracetamol 1gm IV infusion/8 hrs and ketorolac 30 mg IM/12 hrs.). A postoperative rescue analgesia with morphine sulfate IV was given to patients with VAS >4 at a bolus dose of 3 mg increments with a maximum dose of 15mg per 4 hours or 45mg per 24 hours.
Sample size was estimated using G*Power© software version 3.1.9.2 (Institute of experimental psychology, Heinrich Heine University, Dusseldorf, Germany)149 with total opioid consumption among the two groups as the main primary outcome. Previous similar researches150 demonstrated that the effect size between the two groups was expected to be large of 1.12 and it calculated that 42 patients (21 patients per group) would provide to achieve a power of 95% with type I error rate of 0.05. However, we assigned 50 patients (25 patients per group) to compensate for data loss. The collected data were organized, tabulated and statistically analyzed using SPSS software statistical computer package version 22 (SPSS Inc, USA). Data were tested for normality using shapiro-wilks test. Numerical variables such as age, body weight, height and BMI were normally distributed and were described as mean ± standard deviation (SD). An independent t-test was used to compare the mean values of the two groups. Other variables were not normally distributed and were presented as median and interquartile range (IQR); Mann-Whitney U test was used as a test of significance. The time-to-event variable (time to analgesic request) was evaluated using the Kaplan-Meier method, and the logrank test was used to compare the groups. Qualitative data were presented as numbers and percentages, and the chi-squared test was used to determine significance. A two-sided P-value of <0.05 was considered statistically significant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QL block group | Active comparator | Procedure: Ultrasound guided QL blockFor the ultrasound-guided quadratus lumborum block group, the patient was placed in lateral position . QL was identified medial to the aponeurosis of transversus abdominis muscle. Then the needle was inserted from supero-anterior to postero-inferior and advanced using in plane technique till the needle tip reached the anterolateral border of the QL at its junction with transversalis fascia.An injection of 20 mL of 0.25% bupivacaine was applied bilaterally |
| TAP block group | Active comparator | Procedure: Ultrasound guided TAP blockFor the ultrasound-guided TAP block,The probe was placed in the mid-axillary line above the level of the anterior superior iliac spine, then slided cranially till the three abdominal wall muscles identified (External oblique muscle (EAO), internal oblique muscle (IOM) and transverse abdominis muscle (TAM)). The needle was advanced using in-plane technique till it reached the transvers abdominis plane. An injection of 20 mL of 0.25% bupivacaine was applied bilaterally |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients scheduled for elective laparoscopic abdominal surgeries (inguinal hernia repair-missed IUCD extraction-appendectomy-ovarian vein ligation)
- Patient aged 18-60 years
- American Society of Anesthesiologists Physical Status I or II.
Key exclusion criteria (6 listed)
- Patient refusal
- Body mass index (BMI) > 40 kilogram/square meter
- Contraindication to regional anesthesia (coagulopathy, allergy to local anesthetic, sever thrombocytopenia or infection at puncture site)
- Sepsis
- Chronic pain condition requiring the intake of opioids at home
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 |
|---|---|---|
| Ultrasound guided QL block20 mL of 0.25% bupivacaine was applied bilaterally at the anterolateral border of the QL at its junction with transversalis fascia | Procedure or surgery | QL block group |
| Ultrasound guided TAP block20 mL of 0.25% bupivacaine was applied bilaterally in the TAP | Procedure or surgery | TAP block group |
Primary outcome
The total morphine consumption at first 24 hours postoperatively
Time frame: 24 hours postoperatively
amount of morphine used in milligram after each block
19 secondary outcomes
Postoperative pain, assessed using visual analog scale (VAS) score at 30 min postoperatively.
Time frame: 30 minutes postoperatively
Postoperative pain, assessed using visual analog scale (VAS) score at 2 h postoperatively.
Time frame: 2 hours postoperatively
Postoperative pain, assessed using visual analog scale (VAS) score at 4 h postoperatively.
Time frame: 4 hours postoperatively
Postoperative pain, assessed using visual analog scale (VAS) score at 6 h postoperatively.
Time frame: 6 hours postoperatively
Postoperative pain, assessed using visual analog scale (VAS) score at 12 h postoperatively.
Time frame: 12 hours postoperatively
Postoperative pain, assessed using visual analog scale (VAS) score at 24 h postoperatively.
Time frame: 24 hours postoperatively
Time to the first analgesic request
Time frame: 24 hours postoperatively
frequency of patients required postoperative opioid.
Time frame: First 24 hours postoperatively
incidence of postoperative nausea and vomiting
Time frame: First 24 hours postoperatively
incidence of postoperative pruritus
Time frame: First 24 hours postoperatively
incidence of postoperative sedation at 30 min postoperatively
Time frame: at 30 minutes postoperatively
incidence of postoperative sedation at 2 h postoperatively
Time frame: at 2 hours postoperatively
incidence of postoperative sedation at 6 h postoperatively
Time frame: at 6 hours postoperatively
incidence of postoperative sedation at 12 h postoperatively
Time frame: at 12 hours postoperatively
incidence of postoperative sedation at 24 h postoperatively
Time frame: at 24 hours postoperatively
incidence of local anesthetic systemic toxicity
Time frame: in the first 24 hours postoperatively
incidence of vascular injury
Time frame: in the first 24 hours postoperatively
incidence of local hematoma
Time frame: in the first 24 hours postoperatively
incidence of visceral injury
Time frame: in the first 24 hours postoperatively
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 18 Sep 2020.
- Background: PubMed 30662131Kumar GD, Gnanasekar N, Kurhekar P, Prasad TK. A Comparative Study of Transversus Abdominis Plane Block versus Quadratus Lumborum Block for Postoperative Analgesia following Lower Abdominal Surgeries: A Prospective Double-blinded Study. Anesth Essays Res. 2018 Oct-Dec;12(4):919-923. doi: 10.4103/aer.AER_158_18.
- Background: PubMed 29929169Okmen K, Metin Okmen B, Topal S. Ultrasound-guided posterior quadratus lumborum block for postoperative pain after laparoscopic cholecystectomy: A randomized controlled double blind study. J Clin Anesth. 2018 Sep;49:112-117. doi: 10.1016/j.jclinane.2018.06.027. Epub 2018 Jun 18.
- Derived from this study: PubMed 35386840Fargaly OS, Boules ML, Hamed MA, Aleem Abbas MA, Shawky MA. Lateral Quadratus Lumborum Block versus Transversus Abdominis Plane Block in Laparoscopic Surgery: A Randomized Controlled Study. Anesthesiol Res Pract. 2022 Mar 28;2022:9201795. doi: 10.1155/2022/9201795. eCollection 2022.
- Individual participant dataSharing planned: No
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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.
Maged L boules, MD study chair
Faculty of medicine, Fayoum university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided QL block and Ultrasound guided TAP block in people with Abdominal Pain, run by Fayoum University Hospital 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 18 Sep 2020. 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?
The total morphine consumption at first 24 hours postoperatively (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04553991, which also lists 3 linked publications.
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 18 Sep 2020.