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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Egypt

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 groups in NCT04553991
Study groupRoleWhat they receive
QL block groupActive comparatorFor 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 groupActive comparatorFor 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.

  1. 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)
  1. Postoperative pain, assessed using visual analog scale (VAS) score at 30 min postoperatively.

    from 0 to 10 degrees

    Measured: 30 minutes postoperatively

  2. Postoperative pain, assessed using visual analog scale (VAS) score at 2 h postoperatively.

    from 0 to 10 degrees

    Measured: 2 hours postoperatively

  3. Postoperative pain, assessed using visual analog scale (VAS) score at 4 h postoperatively.

    from 0 to 10 degrees

    Measured: 4 hours postoperatively

  4. Postoperative pain, assessed using visual analog scale (VAS) score at 6 h postoperatively.

    from 0 to 10 degrees

    Measured: 6 hours postoperatively

  5. Postoperative pain, assessed using visual analog scale (VAS) score at 12 h postoperatively.

    from 0 to 10 degrees

    Measured: 12 hours postoperatively

  6. Postoperative pain, assessed using visual analog scale (VAS) score at 24 h postoperatively.

    from 0 to 10 degrees

    Measured: 24 hours postoperatively

  7. 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

  8. frequency of patients required postoperative opioid.

    in numbers

    Measured: First 24 hours postoperatively

  9. incidence of postoperative nausea and vomiting

    Any postoperative nausea or vomiting related to morphine consumption

    Measured: First 24 hours postoperatively

  10. incidence of postoperative pruritus

    Any postoperative pruritus related to morphine consumption

    Measured: First 24 hours postoperatively

  11. incidence of postoperative sedation at 30 min postoperatively

    sedation was assessed with a five-point sedation scale

    Measured: at 30 minutes postoperatively

  12. incidence of postoperative sedation at 2 h postoperatively

    sedation was assessed with a five-point sedation scale

    Measured: at 2 hours postoperatively

  13. incidence of postoperative sedation at 6 h postoperatively

    sedation was assessed with a five-point sedation scale

    Measured: at 6 hours postoperatively

  14. incidence of postoperative sedation at 12 h postoperatively

    sedation was assessed with a five-point sedation scale

    Measured: at 12 hours postoperatively

  15. incidence of postoperative sedation at 24 h postoperatively

    sedation was assessed with a five-point sedation scale

    Measured: at 24 hours postoperatively

  16. 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

  17. incidence of vascular injury

    incidence of vascular injury after each block

    Measured: in the first 24 hours postoperatively

  18. incidence of local hematoma

    incidence of local hematoma at injection site after each block

    Measured: in the first 24 hours postoperatively

  19. 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.

  1. First posted18 Sep 2020
  2. Study start1 Jul 2019
  3. Primary completion1 Feb 2020
  4. Study completion1 May 2020

Resources

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)
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 30662131
  • Okmen 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 29929169
  • Fargaly 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

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.

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