Ultrasound Guided Retrolaminar Block Versus Transverse Abdominis Plane Block in Laparoscopic Upper Abdominal Surgeries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-65
SponsorMansoura University
About this trial
This study aims to compare and evaluate the safety and efficacy of ultrasound guided retrolaminar block versus transverse abdominis plane block in laparoscopic upper abdominal surgeries. Both RLB and TAP blockade are hypothesized to reduce analgesic consumption, manage pain effectively and minimize side effects but their comparative effectiveness has not yet to be thoroughly explored.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 21 and 65 years.
American Society of Anesthesiologists (ASA) physical status I or II.
Body mass index (BMI) less than 30 kg/m².
Scheduled for elective laparoscopic upper abdominal surgery under general anesthesia.
Disqualifiers
Refusal to participate in the study.
Known allergy or hypersensitivity to any of the study drugs.
Infection at the planned block insertion site.
Severe uncontrolled cardiac, renal, hepatic, neurological, or respiratory disease.
Trial design
Design model
Parallel
Treatments tested in this trial
Ultrasound-guided Retrolaminar Block group
Procedure/SurgeryUltrasound-guided bilateral retrolaminar block performed before surgery using the study local anesthetic.
Transverses Abdominis Plane (TAP) Block Group
Procedure/SurgeryUltrasound-guided bilateral transversus abdominis plane (TAP) block performed before surgery using the study local anesthetic.
Treatment groups
164 Participants
are divided into 2 treatment groupsGroup A: Retrolaminar Block GroupExperimental treatment 1 intervention
Group B: Transverses Abdominis Plane (TAP) Block GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The postoperative Quality of Recovery-15 score
The Quality of Recovery-15 (QoR-15) questionnaire consists of 15 items. The total score ranges from 0 to 150, with higher scores indicating better postoperative recovery.
Time frame
24 hour postoperativeSecondary outcomes
1
Numeric Rating Scale (NRS) at rest and during coughing
Postoperative pain intensity at rest and during coughing will be assessed using the Numeric Rating Scale (NRS). The NRS ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain . Higher scores indicate greater pain intensity (worse outcome).
Time frame
Immediately after arrival in the post-anesthesia care unit (0 hours), and at 2, 4, 6, 12, and 24 hours after surgery.2
Total dose of rescue analgesics administered (mg) within the first 24 hours after surgery
The cumulative dose of rescue postoperative analgesics administered to each participant during the first 24 hours after surgery will be recorded. Higher values indicate greater postoperative analgesic requirements.
Time frame
From the end of surgery to 24 hours after surgery.3
Time to first postoperative opioid analgesic request (hours)
Time from the end of surgery until the first postoperative request for opioid analgesia
Time frame
From the end of surgery until the first request for opioid analgesia, up to 24 hours postoperatively4
Duration of hospital stay
Duration of hospital stay, measured as the number of days from the date of surgery until hospital discharge.
Time frame
From the date of surgery until hospital discharge, assessed for up to 30 days after surgerySponsors and contacts
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Source ClinicalTrials.gov