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Status unknownNCT03958942Updated Jul 5, 2019

Bilateral Ultrasound Guided Quadratus Lumborum Versus Lumbar Epidural Block on Postoperative Analgesia, and Inflammatory Response in Abdominal Surgery

An interventional study of Ultrasound quadratus lumborum block with bupivacaine 25% and lumbar epideural block with bupivacaine 25% in Postoperative Pain and Inflammatory Response, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-07-05.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
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Study summary

This study aims at comparing the effects of bilateral ultrasound-guided quadratus lumborum block versus lumbar epidural block on postoperative analgesia and inflammatory response following major lower abdominal cancer surgery.

02

Conditions studied

  • Postoperative Pain
  • Inflammatory Response

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03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's planned enrollment of 60 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • ASA II, III
  • Weight 50 - 85 kg.
  • Scheduled for major lower abdominal cancer surgery (radical cystectomy, total abdominal hysterectomy).

Exclusion criteria

Exclusion Criteria:

  • Patients with a history of relevant drug allergy.
  • Coagulation disorders.
  • Opioid dependence.
  • Sepsis.
  • Local infection at the vicinity of the block site.
  • Patients with psychiatric illnesses that would interfere with perception and assessment of pain
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    quadratus lumborum block

    received pre-emptive ultrasound-guided quadratus lumborum block with 25 mL of 0.25% bupivacaine on each side of the abdominal wall before induction of GA.

    Other: Ultrasound quadratus lumborum block with bupivacaine 25%

  • Active comparator
    lumbar epideural block

    received pre-emptive lumbar epidural block with 15 mL of 0.25% bupivacaine before induction of GA.

    Other: lumbar epideural block with bupivacaine 25%

Interventions

  • OtherUltrasound quadratus lumborum block with bupivacaine 25%

    echogenic needle will be inserted in-plane with the ultrasound beam in a posterior-to-anterior direction through the quadratus lumborum muscle until the ventral fascia of the muscle penetrated. At this point, the needle directed toward the fascial plan between the quadratus lumborum and the Psoas muscle

  • Otherlumbar epideural block with bupivacaine 25%

    lumbar epidural will be performed for patients in group II using a 16-gauge Touhy epidural needle by a median approach. The T12 - L1 or L1 - L2 interspaces will be chosen for the injection. The epidural space identified by the loss of resistance technique.

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What researchers measure

Primary outcomes

  1. postoperative pain

    postoperative pain intensity.

    Time frame: first 24 hours postoperatively

Secondary outcomes

  1. postoperative inflammatory response

    inflammatory response represented by the levels of: interleukins 1,6, and tumor necrosis factor alpha

    Time frame: first 24 hours postoperatively

  2. side effects

    sedation, nausea, vomiting, and respiratory depression

    Time frame: first 24 hours postoperatively

07

Study locations

1 of 1 sites recruiting
  • South Egypt Cancer Institute
    Assiut, 171516, Egypt
    • Moaaz El tohamy · Contact
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03958942
Lead sponsor
Assiut University
Responsible party
Ahmad Mohammad Abd El-Rahman (assisstant professor of Anesthesia, ICU, and Pain Management, Assiut University) — Principal investigator
First posted
May 22, 2019
Start date
Jun 1, 2019
Primary completion
Jan 1, 2020 (estimated)
Completion
Mar 1, 2020 (estimated)
Last update
Jul 5, 2019

Study contacts

Ahmad M Abd El-Rahman, M.D.
Contact
ahmad23679@gmail.com
00201149606060

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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