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AnalgesiaNCT04965194

Ultrasound-guided Erector Spinae Block Versus Quadratus Lumborum Block for Laparotomies

A study testing erector spinae plane block and Quadratus lumborum plane block in people with Analgesia, run by Minia University 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 study aimed to compare the effect of ESP block and QL block in preventing postoperative pain and decreasing analgesic consumption in patients scheduled for laparotomies. This prospective randomized controlled study will be done after obtaining ethics committee's permission and written informed consent of the… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Analgesia
What is being tested?
erector spinae plane block and Quadratus lumborum plane block
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteEgypt
Study dates
15 Jul 2021to 1 May 2022
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

  • Aged 18-60 years.
  • ASA I-II.
  • Both sexes.
  • Open laparotomies.

Who cannot join

  • Patient refusal
  • Allergy to local anesthetics
  • BMI >40 kg/m2
  • Bleeding diathesis or history of anticoagulant use.
  • Psychiatric diseases.
  • Infection of the skin at the site of needle punctures area.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Minia University Hospital

    Minya, Minya Governorate, 61111

Other trials in Egypt

About this study

Official title: Ultrasound-guided Erector Spinae Block Versus Quadratus Lumborum Block for Postoperative Analgesia in Laparotomies: Randomized Controlled Study

The study aimed to compare the effect of ESP block and QL block in preventing postoperative pain and decreasing analgesic consumption in patients scheduled for laparotomies.

This prospective randomized controlled study will be done after obtaining ethics committee's permission and written informed consent of the patients 60 adult patients aged 18-60 years scheduled for open laparotomies under general anesthesia will be included in this study.

Read more

According to the used technique, the patients will be randomly allocated into 3 parallel equal groups (20 patients in each one).

Group I (ES group): the patients will receive bilateral ESP block. Group II (QL group): the patients will receive bilateral QL block. Group III (control group): the patients will not receive any regional block.

Read the detailed description

Postoperative pain management is one of the most important issues influencing the outcome of surgery. Postoperative pain, especially when poorly controlled, results in harmful acute effects such as adverse physiological responses and chronic effects like delayed long term recovery and chronic pain.the investigators aimed to compare the effect of ESP block and QL block in preventing postoperative pain and decreasing analgesic consumption in patients scheduled for laparotomies.

Primary outcome:

Total analgesic consumption in the first 24hrs postoperative.

Secondary outcomes:

  1. Time of first analgesic request.
  2. Visual analogue pain score in the first 24hrs postoperative
  3. Incidence of any side effects. All patients will be premedicated using midazolam 0.03 mg /kg iv upon arrival to the operating room then standard monitoring which included SPO2, ECG, non-invasive blood pressure monitoring will be applied. All patients will receive the same anesthetic technique. Following anesthesia induction using 1-2 mcg/kg fentanyl, 2- 3 mg/kg propofol, and 0.5 mg/kg atracurium, the patients will be intubated and maintenance of anesthesia will be done by Isoflurane (MAC 1.2) and intermittent doses of atracurium to maintain adequate muscle relaxation. All hemodynamics will be measured before and after induction of general anesthesia and then every 5 min till end of surgery.

In ES group: superficial probe will be placed 2-3 cm lateral to the spine using a sagittal approach at the level of T7. After identification of erector spinae muscle and transverse processes, the needle will be inserted deeply into the erector spinae muscle. Correct position of the needle tip is confirmed with administration of 0.5-1 ml of local anesthetic (LA), and 20 ml of 0.25% bupivacaine will be administered to perform ESP block. LA spread to both cranial and caudal directions will be seen.

In QL group: A curved array transducer for the transmuscular QL (TQL) nerve block is placed in the axial plane on the patient's flank just cranial to the iliac crest. The "shamrock sign" is visualized: The transverse process of vertebra L4 is the stem, whereas the erector spinae posteriorly, QL laterally, and psoas major anteriorly represents the three leaves of the trefoil. The target for injection is the fascial plane between the QL and psoas major muscles. The needle is inserted using an in-plane technique from the posterior end of the transducer through the QL muscle. The injectate (20ml of bupivacaine 0.25%) should ideally spread from the injection site inside the fascial plane between the QL and psoas major muscles to the thoracic paravertebral space with a goal to accomplish segmental somatic and visceral analgesia from T4 to L1.

Before the end of the surgery all patients will receive 1g of paracetamol IV, at the end of the surgery reversal of neuromuscular blockade will be done by neostigmine and atropine and then the patients will be transferred to recovery room. 30 mg of ketorolac will be given to all patients every 8 hrs.

Parameters will be assessed:

Intraoperative:

Hemodynamics after induction of anesthesia, after block and then every 15min till the end of surgery.

Postoperative:

  1. Hemodynamics immediately after recovery and then 1, 2, 4, 8, 12, 16, 20and 24 hrs postoperative.
  2. VAS in the same previous intervals.
  3. Time of first analgesic request.
  4. Total analgesic requirement in the first 24 hrs. postoperative.
  5. Incidence of side effects.
Conditions
Analgesia
Being tested
erector spinae plane block, Quadratus lumborum plane block, placebo
Keywords
ESPB, QLPB, analgesia, postoperative pain
Medical subject headings
Agnosia, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • erector spinae plane blockProcedure or surgery

    Superficial probe will be placed 2-3 cm lateral to the spine using a sagittal approach at the level of T8. After identification of erector spinae muscle and transverse processes, the needle will be inserted deeply into the erector spinae muscle. Correct position of the needle tip is confirmed with administration of 0.5-1 ml of local anesthetic (LA), and 20 ml of 0.25% bupivacaine will be administered to perform ESP block. LA spread to both cranial and caudal directions will be seen.

  • Quadratus lumborum plane blockProcedure or surgery

    A curved array transducer for the transmuscular QL (TQL) nerve block is placed in the axial plane on the patient's flank just cranial to the iliac crest. The "shamrock sign" is visualized: The transverse process of vertebra L4 is the stem, whereas the erector spinae posteriorly, QL laterally, and psoas major anteriorly represents the three leaves of the trefoil. The target for injection is the fascial plane between the QL and psoas major muscles. The needle is inserted using an in-plane technique from the posterior end of the transducer through the QL muscle. The injectate (20ml of bupivacaine 0.25%) should ideally spread from the injection site inside the fascial plane between the QL and psoas major muscles to the thoracic paravertebral space with a goal to accomplish segmental somatic and visceral analgesia from T4 to L1.

  • placeboOther

    patients received no regional block

Study groups in NCT04965194
Study groupRoleWhat they receive
Erector spinae plane block (ESPB)Experimental20 ml of 0.25% bupivacaine will be administered to perform ESP block on each side
Receives: Procedure: erector spinae plane block
Quadratus lumborum plane block (QLPB)ExperimentalThe injectate (20ml of bupivacaine 0.25%) should ideally spread from the injection site inside the fascial plane between the QL and psoas major muscles to the thoracic paravertebral space with a goal to accomplish segmental somatic and visceral analgesia from T4 to L1.
Receives: Procedure: Quadratus lumborum plane block
Control groupPlacebo comparatorpatients received no regional block
Receives: Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total analgesic consumption

    total fentanyl consumption as rescue analgesia

    Measured: 24 hours

Secondary outcomes (3)
  1. Time of first analgesic request.

    first dose of rescue analgesia

    Measured: 24 hours

  2. dynamic Visual analogue pain score

    degree of pain description on movement from (0-10 )which 0-3 is the no pain, 4-5 mild pain, 6-8 moderate pain and 9-10 severe pain

    Measured: 24 hours

  3. resting Visual analogue pain score

    degree of pain description on rest from (0-10 )which 0-3 is the no pain, 4-5 mild pain, 6-8 moderate pain and 9-10 severe pain

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2021
  2. Study start15 Jul 2021
  3. Primary completion1 Apr 2022
  4. Study completion1 May 2022

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04965194
Sponsor's protocol ID
50:6/2021
Status last verified
Nov 2022
First submitted
3 Jul 2021
Last updated
4 Nov 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing erector spinae plane block and Quadratus lumborum plane block in people with Analgesia, 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 4 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 4 Nov 2022. 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. Some participants in this study may receive a placebo. 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?

Total analgesic consumption (time frame: 24 hours). 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 4 Nov 2022.

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