RLB vs ERSP for Postoperative Analgesia in Lap Cholecystectomy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-60
SponsorSohag University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• 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.
Disqualifiers
• Sensitivities or contraindications to the study medications.
Infection at the site of injection.
Emergency surgery.
Body mass index (BMI) > 35.
Trial design
Design model
Parallel
Treatments tested in this trial
Retrolaminar Block (RLB)
Biological/VaccinePatients 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.
Erector spinae plane block (ESPB)
Procedure/SurgeryThe 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 to caudad until the needle tip contacts the TP of T7. Following hydro dissection with 2 mL of isotonic saline, which elevates the ESM, 20 mL of LA mixture is administered after several negative aspirations.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: RLB groupActive comparator 1 intervention
Group B: ESPB groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time to the 1st rescue analgesia
Time frame
in the 1st 24hr.Secondary outcomes
1
Total morphine consumption
Time frame
in the 1st 24hr.2
Pain score.
postoperative pain assessment with the Numeric Rating Scale (NRS). Numeric rating scale .. zero represents no pain while 10 represents the worst pain imaginable
Time frame
Pain will be assessed at, 2, 4, 6, 8, 12, 18 and 24 hour postoperatively.3
Degree of patient satisfaction
• Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1 represents extremely dissatisfied 2 represesnts unsatisfied; 3 represents neutral 4 represents satisfied 5 represents extremely satisfied)
Time frame
in the first 24 hours after surgerySponsors and contacts
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Source ClinicalTrials.gov
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