NCT07654556

Brief Summary

Interest in surgical weight loss interventions continues to rise in the face of what has been dubbed the obesity epidemic. The most popular of these weight loss interventions is laparoscopic sleeve gastrectomy, which has proven to reduce morbidity and mortality of morbidly obese patients. The aim of effective perioperative pain management extends beyond increased patient comfort and includes reduced recumbency period, enhanced recovery, reduced hospital stay, and lowers postoperative complication rates. Effective postoperative pain management has traditionally relied on multimodal strategies that combine systemic opioids, non-opioid medications, and regional anesthesia. Despite their efficacy, opioids are associated with a range of undesirable effects, such as nausea, vomiting, sedation, pruritus, and respiratory depression, which may impede early mobilization and recovery. These concerns have accelerated the adoption of ultrasound-guided regional anesthesia techniques as part of Enhanced Recovery After Surgery (ERAS) protocols, delivering superior pain control with fewer systemic adverse effects.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
8mo left

Started Jul 2026

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Jul 2026Mar 2027

First Submitted

Initial submission to the registry

June 13, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 17, 2026

Completed
14 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2027

Last Updated

June 18, 2026

Status Verified

June 1, 2026

Enrollment Period

9 months

First QC Date

June 13, 2026

Last Update Submit

June 16, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative Visual Analogue Score

    Measurment of postoperative Visual Analogue Score, which is a scale from 0 to 10 in which 0 indicates no pain while 10 denotes unbearable pain, this will be done after 48 hours.

    48 hours

Study Arms (2)

Modified thoracoabdominal plane block through perichondrial approach (M-TAPA)

ACTIVE COMPARATOR

The M-TAPA block will be performed after induction of general anaethesia, with total volume of 25ml of 0.25% bupivacaine.

Drug: Bupivacaine 0.25% (isobaric)

Erector Spinea plane block (ESP block)

ACTIVE COMPARATOR

The ESP block will be performed after induction of general anaethesia , with total volume of 40 ml of 0.25% bupivacaine.

Drug: Bupivaciane 0.25% (Isobaric)

Interventions

A bilateral injection of 25 ml of 0.25% bupivacaine will be injected as a part of ultrasound guided M-TAPA block.

Modified thoracoabdominal plane block through perichondrial approach (M-TAPA)

A bilateral injection of 25 ml of 0.25% bupivacaine will be injected as a part of ultrasound guided ESP block.

Erector Spinea plane block (ESP block)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients from both sexes.
  • to 60 years old.
  • ASA physical status II-III scheduled for laparoscopic sleeve gastrectomy.
  • Patients with BMI (40-50) kg/ m2

You may not qualify if:

  • Patient Refusal
  • Lack of patient cooperation.
  • Patients with any contraindication to regional nerve blocks as coagulopathy or infection at site of injection
  • Patients with anatomical abnormalities at site of injection
  • Patients with known hypersensitivity to bupivacaine, or any of the used drugs.
  • Patients with pre-existing neurological disorder
  • Patients with chronic pain syndromes including fibromyalgia, complex regional pain syndrome (CRPS), or chronic pain requiring long-term opioid or neuropathic pain medications.
  • Patients with history of long-acting opioids, steroids, anticonvulsants perioperatively.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

Hesham khedr Prof. Dr., Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

June 13, 2026

First Posted

June 17, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

March 30, 2027

Last Updated

June 18, 2026

Record last verified: 2026-06