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Enrolling by invitation NCT06599255

One-Puncture Versus Multipoint Technique of Rectus Sheath Block With Transverse Abdominis Plane Block

No phase Interventional Laparoscopic Cholecystectomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: US-guided RSB and TAPB by one-puncture technique., multipont.
Who it may be relevant to
Registry conditions: Laparoscopic Cholecystectomy. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

One-Puncture Versus Multipoint Technique of Rectus Sheath Block With Transverse Abdominis Plane Block for Analgesia After Laparoscopic Cholecystectomy

Overview

the purpose of this study is to compare of better postoperative analgesia following laparoscopic cholecystectomy using either one puncture rectus sheath block with transverse abdominis plane block or multipoint technique

Detailed description

after being informed about the study and potential risks. All patients giving written consent will be randomized by double blind manner into 3 groups each one containing 34In the One puncture \"O\" group (n= 34): The patient will receive one-puncture technique of RSB combined with TAPB.

In the Multipoint \"M \" group (n= 34): The patient will receive multipoint technique of RSB combined with TAPB.

In the Control \"C \" group (n=34 ): The patient will receive patient controlled analgesia\&;PCA\&

Interventions

  • Procedure US-guided RSB and TAPB by one-puncture technique.
    The probe will be positioned transversely in the midline of the abdomen, between the xiphoid process and the umbilicus, revealing the linea alba. It was then moved outward along the costal margin, demonstrating the rectus abdominis overlapping the transverse abdominis. A 22-gauge, 120-mm ultrasound-visible block needle will be inserted from the inner side . Under direct vision, we will reach the posterior rectus abdominis sheath and pierced the anterior layer of the posterior sheath. Saline was
  • Procedure multipont
    , the probe will be moved outward along the costal margin until the external oblique muscle, internal oblique muscle, and transverse abdominis muscle will be visible \[9\]. The needle will be inserted in-plane until the tip was positioned in the plane between the internal oblique muscle and the transverse abdominis muscle. Then, 15 mL of 0.25% bupivacaine will be injected . The contralateral nerve block will be performed using the same method and volume of anesthetic solution. For the RSB, the

Primary outcome measures

  • The total postoperative opioid consumption in the first 24 hours. [Time frame: 24 hours postoperative]
Secondary outcome measures (4)
  • The block performance time [Time frame: up to 5 minutes]
  • Onset of sensory block [Time frame: up to 30 minutes]
  • The Numerical Pain Rating Scale [Time frame: 24 hours postoperative]
  • Patient satisfaction [Time frame: 24 hour postoperative]

Eligibility criteria

Inclusion criteria

  • Age: 18-45 years old.
  • Sex: both sexes.
  • Physical status: ASA I to III.
  • Body mass index (BMI): 18- 30 kg/m2.
  • Type of operations: elective laparoscopic cholecystectomy.
  • Written informed consent from the patient.

Exclusion criteria

  • Known hypersensitivity to lidocaine or bupivacaine.
  • Opioid-dependent patients.
  • Coagulation disorders or taking drugs affect surgical hemostasis.
  • Patients with pre-existing neurological deficits.
  • Uncooperative patient or with altered mental status.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Medicine,Zagazig University — Zagazig

Identifiers

NCT: NCT06599255 · ZU-IRB#568/27-AUG-2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗