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Not yet recruiting NCT07598162

RLB vs ERSP for Postoperative Analgesia in Lap Cholecystectomy

No phase Interventional Laparoscopic Cholecystectomy Surgery Postoperative Analgesia

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: Retrolaminar Block (RLB), Erector spinae plane block (ESPB).
Who it may be relevant to
Registry conditions: Laparoscopic Cholecystectomy Surgery Postoperative Analgesia. Basic parameters: 20 years — 60 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 →

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Official title

Retrolaminar Block Versus Erector Spinae Plane Block for Postoperative Analgesia in Laparoscopic Cholecystectomy: A Comparative Randomized Prospective Study

Overview

This prospective, randomized, double-blind clinical trial evaluates the comparative effectiveness of ultrasound-guided retrolaminar block (RLB) and erector spinae plane block (ESPB) for postoperative analgesia in patients undergoing laparoscopic cholecystectomy. A total of 100 ASA I-II patients, aged 20-60 years, will be randomly allocated into two equal groups to receive either RLB or ESPB bilaterally following induction of standardized general anesthesia. The primary outcome is the time to first request for rescue analgesia, while secondary outcomes include total morphine consumption within the first 24 hours, postoperative pain scores assessed using the Numeric Rating Scale (NRS), patient satisfaction, and the incidence of adverse events. Pain assessment will be performed at predefined intervals over the first 24 hours postoperatively. The study aims to determine which technique provides superior analgesia with reduced opioid requirements and improved patient outcomes.

Interventions

  • Biological Retrolaminar Block (RLB)
    Patients will be positioned laterally, and a curved ultrasound probe will be aligned longitudinally at the T7 vertebra. The vertebral lamina and spinous process will be identified. A needle will be inserted 1 - 1.5 cm lateral to the spinous process, advanced toward the lamina, and 20 mL of LA mixture will be injected into the fascial plane between the lamina and transversus spinae muscles bilaterally.
  • Procedure Erector spinae plane block (ESPB)
    The blocks will be conducted at the level of the T7 spinous process (SP) with the patient in the lateral position and the arm abducted. Using US ( curved probe ) , the T7 transverse process (TP) is identified by counting from the 12th rib. The US probe is positioned 2 - 3 cm laterally to the SP of T7 and situated over the TP of T7/T8 in the parasagittal longitudinal plane, with the erector spinae muscle (ESM) visualized over the TP. The needle is then inserted and advanced in plane from cephalad

Primary outcome measures

  • Time to the 1st rescue analgesia [Time frame: in the 1st 24hr.]
Secondary outcome measures (3)
  • Total morphine consumption [Time frame: in the 1st 24hr.]
  • Pain score. [Time frame: Pain will be assessed at, 2, 4, 6, 8, 12, 18 and 24 hour postoperatively.]
  • Degree of patient satisfaction [Time frame: in the first 24 hours after surgery]

Eligibility criteria

Inclusion criteria

  • • Age from 20 to 60 years.
  • Both sexes.
  • American Society of Anesthesiology (ASA) grade I and II physical status.
  • Patients will undergo cholecystectomy under general anesthesia.

Exclusion criteria

  • • Sensitivities or contraindications to the study medications.
  • Infection at the site of injection.
  • Emergency surgery.
  • Body mass index (BMI) > 35.
  • Organic comorbidities.
  • Histories of psychological conditions and/or chronic pain syndromes.
  • Contraindications to regional anesthesia.
  • Severe respiratory, cardiac, hepatic and renal disorders.
  • Pregnancy.
  • Coagulopathy.
  • Opioid addiction.

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
  • Sohag Faculty of Medicine — Sohag

Identifiers

NCT: NCT07598162 · soh-Med-26-3-9MS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗