NCT06841783

Brief Summary

Obesity is a complex chronic disease that has become a major public health concern worldwide, with the prevalence of obesity increasing dramatically over the past few decades. Patients with morbid obesity pose a challenge for perioperative pain management. High ceiling analgesics-opioids have limited role due to safety concerns for patients with or without obstructive sleep apnea . Insufficient postoperative pain management can have negative effects on recovery and quality of life, as well as limit patient comfort and delay the patient's ability to return to work after surgery . Due to the numerous negative side effects of opioid drugs, including physical dependence, nausea, vomiting, and respiratory depression and subsequent airway obstruction, the Enhanced Recovery after Surgery (ERAS) guidelines for bariatric surgery currently advise opioid reduction in this procedure. Ultrasound-guided erector spinae plane block (ESPB) and modified thoracoabdominal nerve block (M-TAPA) are both regional anesthesia techniques used to provide perioperative analgesia for obese patients undergoing LSG . The ESPB targets the spinal nerves as they exit the erector spinae muscle, providing analgesia to the abdominal wall and paraspinal muscles. The technique has shown promising results in various surgical procedures and has a low risk of complications. By blocking the spinal nerves, the ESPB can provide effective pain relief in the postoperative period for patients undergoing LSG . On the other hand, the M-TAPA targets the thoracic intercostal nerves and the abdominal wall, providing analgesia to these areas. The technique has been shown to provide effective perioperative analgesia in patients undergoing LSG. With or without ultrasound guidance, the use of M-TAPA can provide effective pain relief and reduce the need for opioid medication in the postoperative period. This study aimed to compare the analgesic effect of ultrasound guided modified thoracoabdominal nerve block and an erector spinae plain block in patients undergoing LGS

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 24, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

February 24, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2026

Completed
Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

February 19, 2025

Last Update Submit

January 6, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to first rescue analgesia

    it is defined as time from extubation until time to first analgesic requirement during the first 24 hours postoperatively.

    the first 24 hours postoperatively

Secondary Outcomes (1)

  • The total opioid consumption

    the first 24 hours postoperatively

Study Arms (2)

Erector Spinae Plane Block

EXPERIMENTAL

Ultrasound-Guided Erector Spinae Plane Block

Procedure: nerve block

Modified Thoracoabdominal Nerve Block

EXPERIMENTAL

Ultrasound-Guided Modified Thoracoabdominal Nerve Block

Procedure: nerve block

Interventions

nerve blockPROCEDURE

ultrasound guided nerve block

Erector Spinae Plane BlockModified Thoracoabdominal Nerve Block

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. ASA II \& ASA III. 2. Gender both males and females 3. Age group: from 18 to 65 years old

You may not qualify if:

  • Patient refusal.
  • Uncooperative patients.
  • Allergy to local anesthetics.
  • Anatomical abnormality at injection site.
  • Redo or combined cholecystectomy surgery.
  • Infection at injection site.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy

Cairo, Egypt

Location

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Nerve Block

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaDenervationNeurosurgical ProceduresSurgical Procedures, Operative

Study Officials

  • ahmed abdallah, Professor

    anesthesia department , cairo university

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients will be randomly allocated by a computer-generated table into two of the study groups, the randomization sequence had been concealed in sealed opaque envelopes that will be opened by third doctor who will not participating in the study. The details of the series will be unknown to the investigators and the group assignment will kept in a set of sealed envelopes each bearing only the case number on the outside. This study will be performed by 2 anesthetists; one anesthetist who is experienced in performing the blocks that allocated to perform either Erector Spinae block or modified thoracoabdominal nerve block. According to a computer-generated sequence of random numbers and sealed envelope, and the other anesthetist will be blinded to the technique performed, and will monitor the patients intra and postoperatively.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anesthesia

Study Record Dates

First Submitted

February 19, 2025

First Posted

February 24, 2025

Study Start

February 24, 2025

Primary Completion

January 6, 2026

Study Completion

January 6, 2026

Last Updated

January 8, 2026

Record last verified: 2026-01

Locations