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the purpose of study is comparison between the analgesic effect of two techniques in adult lower abdominal surgeries
the study will be performed from November 2021 to January 2023 at Fayoum University hospital after approval of the local institutional ethics committee and local institutional review board .A detailed informed consent will be signed by the eligible participants before recruitment and randomization.
Preoperative preparations and Premedication :•
Both groups will be assessed by history taking, careful examination ,and laboratory investigations like:
Complete blood count (CBC), coagulation profile:(prothrombin concentration(PC),Partial thromboplastin time(PTT),International Normalized Ratio(INR) ) , kidney function, liver function, ECG for patient >40 years old or indicated cases, specific investigations to each disease
.•the investigators will teach the patients Visual Analogue Score (VAS) and train them.
Intra operative technique and management:
When patients reach Theater, standard American Society of Anesthesiology(ASA) monitoring by (noninvasive blood pressure (NIBP), pulse oximetry, electrocardiography, and capnography) will be applied.
the investigators will allocate basal data for each patient like: heart rate (HR), systolic and diastolic blood pressure, mean arterial blood pressure and arterial oxygen saturation will be recorded. Intravenous cannulation (IV) and intravenous fluid will be started. Intravenous Midazolam 0.03-0.05 mg/kg will be administered to all patients as premedication, Then the patients undergoing general anesthesia, At the first pre-oxygenation with O2100% for at least 3-5 min then the investigators will start Induction of anesthesia for both groups, general anesthesia will be induced with intravenous injection of fentanyl (1-2 µg/kg) and propofol (1, 5 - 2 mg/kg), and then atracurium (0.5 mg/kg) will be injected for endotracheal intubation. Mechanical ventilation will be maintained by controlled mechanical ventilation (CMV) mode with tidal volume ( 6-8ml /kg) with oxygen and air (50:50) with target of EtCo2≈ 30-40 mmHg, anesthesia will be maintained with isoflurane 1%-2% , Incremental dose of atracurium (0.1 mg/kg) will be given every 20 min or when needed. In addition, 0.5μg/kg fentanyl will be given intraoperatively once needed (increase of heart rate or NIBP more than 20% of the basal records) After endotracheal intubation and finishing the operation before awakening of patients the anesthesiologist will perform either the (QL) block technique or the (ESPB) block technique.
Statistical analysis:
The collected data will be organized, tabulated and statistically analyzed using SPSS software statistical computer package version 22 (SPSS Inc, USA). For quantitative data, the mean and standard deviation (SD) or median and interquartile range will be calculated. Independent-t test or Mann-Whitney U test, when appropriate, will be used as a test of significance. Qualitative data will be presented as number and percentages, chi square (χ2) will be used as a test of significance. For interpretation of results of tests of significance, significance will be adopted at P ≤ 0.05.
Sample size was calculated using (G power version 3). Minimal sample size of patients was 20 in each group needed to get power level 0.90, alpha level 0.05 (two tailed) and effect size of 1.08 for the overall dose of morphine. To overcome problem of loss of follow up, calculated sample size was increased by 20% to reach 24 in each group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (QL) group | Active Comparator | In (QL) group, (lateral Approach) :patient receive this block with 20 mg bupivacaine hydrochloride plus 4mg dexamethasone |
|
| (ESB) group | Active Comparator | In (ESB) group, Erector Spinae Plane Block: patient receive this block with 20 mg bupivacaine hydrochloride plus 4mg dexamethasone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine Hydrochloride | Drug | 20mg of Bupivacaine hydrochloride as local anesthetic will be used in (QL) group and (ESB) group |
|
| Measure | Description | Time Frame |
|---|---|---|
| morphine consumption | Millie gram | 24 hours after the end of operation |
| Measure | Description | Time Frame |
|---|---|---|
| Ease of performance. | time required to perform the block in minutes . | during performance of the block |
| Bowel injury | yes or no | 24hours after operation |
| Measure | Description | Time Frame |
|---|---|---|
| time of first using of analgesic | The time of first use of morphine in hours | 24 hours |
| Visual Analogue Score immediately . | measuring post operative pain level using Visual Analogue Score (VAS) range from (0) no pain to (10) sever pain immediately post operatively |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| rana A. Abdelghaffar, MD | faculty of medicine ,Fayum university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fayoum University hospital | Al Fayyum | Fayoum Governorate | 63514 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27501016 | Background | Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451. | |
| 28188611 | Background | El-Boghdadly K, Pawa A. The erector spinae plane block: plane and simple. Anaesthesia. 2017 Apr;72(4):434-438. doi: 10.1111/anae.13830. Epub 2017 Feb 11. No abstract available. |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D014463 | Ultrasonography |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Randomization will be done by random sequence number generated by the computer kept in sealed envelopes. Those envelopes will be opened on the day of surgery when the patient is in the operating room and participant will receive either (QLB) or (ESPB) as per the envelope.
|
| Ultrasound device | Device | high-frequency linear probe covered with sterile sheath Active Array L12-4 (8-13MHz) of an ultrasound machine (Philips clear vue350, Philips Healthcare, Andover MA01810, USA) for performing the blocks . |
|
| Dexamethasone | Drug | injection of 4mg dexamethasone in each block |
|
|
| echogenic needle | Device | 22- gauge, 50 mm echogenic needle (Stimuplex D; B Braun, Germany) for performing the blocks . |
|
| intra vascular injection | yes or no | 24hours after operation |
| Hematoma formation | yes or no | 24hours after operation |
| Pruritus | yes or no | 24hours after operation |
| Nausea | yes or no | 24hours after operation |
| vomiting | yes or no | 24hours after operation |
| patient satisfaction | According to a satisfaction score (poor = zero; fair = one; good = two; excellent= 3). | 24 hours after operation |
| 1 minute post operative |
| Visual Analogue Score at (4) | measuring post operative pain level using Visual Analogue Score (VAS)at(4)hours post operatively | 4 hour post operative |
| Visual Analogue Score at (8) | measuring post operative pain level using Visual Analogue Score (VAS)at(8)hours post operatively | 8 hours post operative |
| Visual Analogue Score at (12) | measuring post operative pain level using Visual Analogue Score at(VAS)(12)hours post operatively | 12 hours post operative |
| Visual Analogue Score at ( 24) | measuring post operative pain level using Visual Analogue Score (VAS)at(24)hours post operatively | 24 hours post operative |
| Age | in years | 1 hour before operation |
| Weight | in kg | 1 hour before operation |
| height | meter | 1 hour before operation |
| BMI | kg/m2 | 1 hour before operation |
| D000588 |
| Amines |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |