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CompletedNCT06564610Updated Jan 13, 2025

Laparoscopic Transversus Abdominis Plane Block Versus Erector Spinae Plane Block in Bariatric Surgery

An interventional study of Transversus abdominis block and Erector spinae block in Pain, Postoperative, Obesity and Analgesia, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-01-13.

Sponsored by Cairo University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study summary

The aim of this work is to compare the analgesic efficacy of laparoscopic transversus abdominis plane block, performed by the surgeon to ultrasound-guided erector spinae plane block, performed by the anesthetist, in patients with obesity undergoing bariatric surgery.

Read the detailed description

This is a randomized controlled trial which will include patients with obesity undergoing bariatric surgery. The patients will be randomly allocated into two groups: transversus abdominis plane block group and erector spinae plane block group. The block will be performed after induction of general anesthesia. Preoperative evaluation and preparation will include history-taking, laboratory investigation, fasting recommendations, and optimization of the medical status. The two groups will receive standard induction and maintenance of anesthesia. After the end of the operation, patients will receive standard care according to the local protocols and the enhanced recovery recommendations. Patients will be monitored according to the pain-related outcomes as well as hemodynamic parameters.

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Conditions studied

  • Pain, Postoperative
  • Obesity
  • Analgesia

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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 enrollment of 96 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

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Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) 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 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with obesity undergoing laparoscopic bariatric surgery under general anesthesia.

Exclusion criteria

Exclusion Criteria:

  • Allergy to local anaesthetic.
  • Bleeding disorders.
  • Obstructive sleep apnea.
  • inability to understand the numerical rating scale for pain assessment.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
96 participants (actual)

Study arms

  • Experimental
    Transversus abdominis block

    Patients in this group will receive Transversus Abdominis block guided by the laparoscope at the beginning of surgery.

    Procedure: Transversus abdominis block · Procedure: Bariatric surgery · Device: Endotracheal intubation · Drug: Propofol

  • Active comparator
    Erector spinae block

    Patients in this group will receive Erector Spinae block guided by the ultrasound after induction of anesthesia.

    Procedure: Erector spinae block · Procedure: Bariatric surgery · Device: Endotracheal intubation · Drug: Propofol

Interventions

  • ProcedureTransversus abdominis block

    The block will be performed by the surgeon by injecting local anesthetic at the beginning of surgery under the guidance of the laparoscope.

  • ProcedureErector spinae block

    The block will be performed by the anesthetist by injecting local anesthetic after induction of anesthesia under the guidance of the ultrasound.

  • ProcedureBariatric surgery

    Laparoscopic bariatric procedure will be performed

  • DeviceEndotracheal intubation

    An endotracheal tube will be inserted as a part of general anesthesia to all patients

  • DrugPropofol

    The patients will receive propofol for induction of anesthesia

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What researchers measure

Primary outcomes

  1. Numerical rating scale

    This is a scale for pain assessment which ranges between 0 and 10 with the highest level of pain having score 10 and lowest level of pain having score 0

    Time frame: 24 hours after surgery

Secondary outcomes

  1. Consumption of analgesia

    This is the total consumption of nalbuphine by the patient measured in milligrams

    Time frame: 24 hours after surgery

  2. Heart rate

    This is the number of heart beats measured as frequency of heart beats in one minute.

    Time frame: 24 hours after surgery

  3. Systolic blood pressure

    This is the systolic arterial blood pressure measured in mmHg.

    Time frame: 24 hours after surgery

  4. Vomiting

    This is the incidence of vomiting after surgery measured as the frequency of patients with vomiting.

    Time frame: 24 hours

  5. Diastolic blood pressure

    This is the diastolic arterial blood pressure measured in mmHg.

    Time frame: 24 hours

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Study locations

1 site
  • Faculty of medicine, Cairo University.
    Cairo, 11432, Egypt
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2025, 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
NCT06564610
Lead sponsor
Cairo University
Responsible party
Ahmed Hasanin (Professor, Cairo University) — Principal investigator
First posted
Aug 21, 2024
Start date
Aug 25, 2024
Primary completion
Jan 5, 2025
Completion
Jan 9, 2025
Last update
Jan 13, 2025

Study contacts

Ahmed Hasanin, Professor
principal investigator · Professor of anesthesia

Oversight

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

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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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