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This study aims to compare the analgesic efficacy of transversus abdominis-plane block with bupivicaine versus bupivacaine with morphine in patients undergoing major abdominal cancer surgery.
This randomized study will be approved by the local ethics committee of South Egypt Cancer Institute, Assuit University, Egypt after written informed consent. This study will include approximately 60 ASA I-II cancer patients with age range (18-60) years, weight (50- 85) kg who will be scheduled for lower abdominal cancer surgery (abdominal hysterectomy, oophorectomy and radical cystectomy). Exclude from the study Patients with known drug allergy to study drugs, significant cardiac, respiratory, renal or hepatic disease, coagulation disorders and those with psychiatric illnesses that would interfere with perception and assessment of pain. Preoperatively, patients will be taught how to evaluate their own pain intensity using the Visual Analog Scale (VAS), scored from 0-10 (where 0= no pain and 10=worst pain imaginable).
Patients will be randomly assigned using an online research randomizer into two groups, 30 patients in each group:
Group 1:
30 patients receive ultrasound guided transversus abdominis-plane block with local anesthetic 20 ml of bupivacaine 0.5 % diluted in 20 ml saline (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of the abdominal wall.
Group 2:
30 patients receive ultrasound guided transversus abdominis-plane block with local anesthetic 20 ml of bupivacaine 0.5% + 10 mg morphine diluted in 20 ml saline (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of the abdominal wall.
Surgery will be performed under standard general anesthesia and ultrasound guided TAP block will be performed before induction of GA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAP with bupivicaine | Placebo Comparator | 30 patients receive ultrasound guided transversus abdominis-plane block (TAP) with local anesthetic 20 ml of bupivacaine 0.5 % diluted in 20 ml saline (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of the abdominal wall. |
|
| TAP with bupivicaine with morphine | Active Comparator | 30 patients receive ultrasound guided transversus abdominis-plane block (TAP) with local anesthetic 20 ml of bupivacaine 0.5% + 10 mg morphine diluted in 20 ml saline (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of the abdominal wall. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transversus abdominis-plane block with local anesthetic 20 ml of bupivacaine 0.5% + 10 mg morphine | Drug | compare the analgesic efficacy of transversus abdominis-plane block with bupivicaine with morphine in patients undergoing major abdominal cancer surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| The presence and severity of pain at rest and on coughing will be assessed using a Visual Analog Scale | The presence and severity of pain at rest and on coughing will be assessed using a Visual Analog Scale will be assessed postoperatively at baseline, 2, 4, 6, 8, 12, 18, and 24 hours. | first 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| the level of sedation by using sedation score | the level of sedation by using sedation score (awake and alert = 0, quietly awake = 1, asleep but easily roused= 2, deep sleep = 3) will be assessed postoperatively at baseline, 2, 4, 6, 8, 12, 18, and 24 hours. | 24 hours postoperatively |
| first request for analgesia in minutes will be observed |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Egypt Cancer Instuite | Asyut | 171516 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28494906 | Derived | El Sherif FA, Mohamed SA, Kamal SM. The effect of morphine added to bupivacaine in ultrasound guided transversus abdominis plane (TAP) block for postoperative analgesia following lower abdominal cancer surgery, a randomized controlled study. J Clin Anesth. 2017 Jun;39:4-9. doi: 10.1016/j.jclinane.2017.03.009. Epub 2017 Mar 10. |
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| firsr 24 hours |
| ID | Term |
|---|---|
| D000779 | Anesthetics, Local |
| D002045 | Bupivacaine |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
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