Post Operative Analgesia
Conditions
Brief summary
The investigators hypothesis that PENG block will produce effective opioid sparing analgesia with enhanced motor recovery more than AQLB in elderly patients undergoing total hip replacement surgeries
Detailed description
Aim of the work: The aim of this study is to compare analgesic efficacy and motor recovery of the ultrasound guided anterior quadratus lumborum block and the pericapsular nerve group block Statistical Analysis: Data will be coded and entered using the statistical package SPSS version 22. Categorical data will be expressed frequency and proportion and will be compared by Chi2. Numerical data will be summarized using mean and standard deviation. Comparisons between groups for normally distributed data will be done using analysis of variance (ANOVA), while for non-normally distributed numeric variable will be done by Krauskal Wallis test. P value less than or equal to 0.05 will be considered statistically significant. All test will be two tailed
Interventions
PROCEDUREAnterior quadratus lumborum block technique (AQLB)
AQLB performed in the lateral position. A low-frequency convex probe for the abdomen (2-5) MHz convex probe, (Siemens ACUSON X300 Ultrasound System) was placed horizontally above the iliac crest. On ultrasound, The psoas major was located on the ventral side of the transverse process, the erector spinae was located on the dorsal side of the transverse process, and the quadratus lumborum was located on the lateral side of the transverse process. A 38-mm 22-gauge regional block needle was advanced in-plane from posterior to anterior directing the needle tip in the fascial plane between the psoas major and the quadratus lumborum that was confirmed by injecting 1 ml saline and watchingt the fluil fting the muscle while not distending any of the two muscles (hydro-localization). Then 30mL of local anaesthetic (29ml of 0.25% bupivacaine + 1 ml of dexamethasone (4mgs) was injected with observation of local anaesthesia spread in the fascial plane.
PROCEDUREPericapsular Nerve Group (PENG) block
With the patients in supine position, A low-frequency convex probe (2-5 MHz) in was placed in a transverse plane over the anterior inferior iliac spine and then it was rotated 45 degrees in counter-clockwise direction to be aligned with the pubic ramus. In this view, the ilio-pubic eminence, iliopsoas muscle tendon, femoral nerve and vessels was observed. With in-plane approach, a 38-mm 22-gauge (22-G, 50-mm) regional block needle inserted in-plane, from lateral to medial to place the needle tip underneath the iliopsoas tendon, exactly between the ilipsoas fascia anteriorly and the pubic ramus posteriorly. Following negative resistance and aspiration tests, correct location of the needle tip was confirmed by injecting 1 ml saline. Then, 30mL of local anaesthetic (29ml of 0.25% bupivacaine+ 1ml of dexamethasone (4mgs) was injected while observing for adequate fluid spread.
DRUGControl Group
Pataints received opioid analgesia with genaral anesthesia
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 65 Years
Healthy volunteers
No
Inclusion criteria
* Both genders * Type of surgery; unilateral elective total hip replacement. * Physical status ASA I- III * Age ≥ 65 Years. * Body mass index (BMI): \> 20 kg/m2 and \< 35 kg/m2. * Traumatic fracture hip through anterolateral approach.
Exclusion criteria
* Patient refusal. * Patients with known sensitivity or contraindication to drugs used in the study (local anesthetics \& opioids). * History of psychological disorders and/or chronic pain. * Pre- existing peripheral neuropathies * Coagulopathy. * Infection of the skin at the site of needle puncture area. * Active cardiac condition (unstable coronary syndromes, significant arrhythmias, severe valvular disease). * Acute respiratory disease (active chest infection, respiratory failure). * Advanced liver disease (increased liver enzymes \>3 folds) or severe kidney disease (creatinine \>2). * long operative time more than 3 hours.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Total Amount of Morphine Consumption | Immediatly post operative for 24 hours | Total dose of IV morphine (mg) administered as rescue analgesia during the first 24 postoperative hours. Morphine 0.05 mg/kg IV boluses were given when NRS ≥4, up to a maximum of 0.3 mg/kg/24 h. Reported as median (IQR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Pain Rating Scale at Rest Over First 24 Hours | 30 minutes, 2, 4, 6, 8, 12, 18, and 24 hours after surgery | Pain intensity at rest using 0-10 Numeric Pain Rating Scale (0 = no pain, 10 = worst imaginable pain) measured at specified time points; data reported as median (IQR). |
| Numeric Pain Rating Scale During Passive 90° Hip Flexion Over First 24 Hours | at 30 minutes, 2, 4, 6, 8, 12, 18 and 24 hours postoperatively | Pain intensity during passive 90° hip flexion using 0-10 NRS at same time points; reported as median (IQR). |
| Time to First Rescue Morphine Analgesia | Immediatly post operative for 24 hours | Time from arrival in PACU to first administration of IV morphine rescue dose (NRS ≥4). Reported as median (IQR). |
| Manual Muscle Test (MMT) Score for Quadriceps/Iliopsoas Over First 24 Hours | 30 minutes, 2, 4, 6, 8, 12, 18 and 24 hours postoperatively | Manual muscle test (0-5 scale; 0 = no contraction, 5 = full ROM against gravity and maximal resistance) for quadriceps and iliopsoas muscles on the operated side, after extubation, at predefined time points. |
| Active Hip Flexion Range of Motion (0°-90°) Over First 24 Hours | 30 minutes, 2, 4, 6, 8, 12, 18 and 24 hours postoperatively | Active hip flexion range of motion (degrees) of the operated hip, from 0° to 90°, assessed at same time points as MMTe. Reported as median (IQR). |
| Total Intraoperative Fentanyl Dose | During surgery | Total dose of IV fentanyl administered intraoperatively. Additional boluses of 1 μg/kg were given if MAP or HR increased by \>20% above baseline. Reported as mean ± SD. |
| Time to First Walk | From end of surgery until first walk (within postoperative 24 h) | Time from end of surgery to first ambulation (≥3 steps with walker). Reported as median (IQR) |
| Length of Hospital Stay | From date of surgery until discharge | Time from surgery to hospital discharge. Reported as mean ± SD. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORMohamed A Ollaek, MD
Cairo University
Participant flow
Recruitment details
Elderly patients (≥65 years) with traumatic hip fractures scheduled for elective unilateral total hip arthroplasty via an anterolateral approach under general anesthesia were recruited at the Orthopedic Surgical Theater, Cairo University Hospital. Recruitment occurred at a single tertiary university hospital in Egypt.
Pre-assignment details
No wash-out or run-in phase. All eligible, consenting patients were randomized 1:1:1 immediately before surgery after induction of general anesthesia. No participants were excluded after enrollment and before assignment to study arms.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age | 70.87 years STANDARD_DEVIATION 4.74 |
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 31 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment Egypt | 31 Participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 31 | 0 / 31 |
| other Total, other adverse events | 0 / 31 | 0 / 31 | 7 / 31 |
| serious Total, serious adverse events | 0 / 31 | 0 / 31 | 0 / 31 |
Outcome results
None listed