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| Name | Class |
|---|---|
| Services Institute of Medical Sciences, Pakistan | OTHER_GOV |
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To compare the clinical outcomes of intraperitoneal bupivacaine instillation vs placebo as preemptive analgesia in patients undergoing open appendectomy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A participants who will receive Bupivacaine Intraperitoneally | Experimental | This group consists of 30 participants and will receive Bupivacaine with 0.25% of concentration intraperitoneally during open appendectomy. Surgery duration will be noted. Analgesic consumption will also be recorded at 2, 6, 12 and 24 hours postoperatively. 1st Rescue analgesia will be given in the form of injection Ketorolac at a dose of 0.5mg/kg whenever the patient reported visual analogue score greater and equal to 4. However, if 1st rescue analgesia fails injection Nalbuphine with dose of 0.1mg/kg per dose will be used as 2nd rescue analgesia. Injection paracetamol 1g IV TDS will be given to all patients considered to be sufficient 1st line analgesia. Patients will be discharged 2 days after surgery when diet and pain will be tolerated. If pain persisted at the time of discharge, oral analgesics will be given for 3 or 4 days. Post operative follow up will be done according to protocol. All information will be recorded on a preformed proforma. |
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| Group B participants who will receive 10 ml of normal saline Intraperitoneally | Active Comparator | This group consists of 30 participants and will receive 10 ml of Normal Saline intraperitoneally during open appendectomy. Surgery duration will be noted. Analgesic consumption will also be recorded at 2, 6, 12 and 24 hours postoperatively. 1st Rescue analgesia will be given in the form of injection Ketorolac at a dose of 0.5mg/kg whenever the patient reported visual analogue score greater and equal to 4. However, if 1st rescue analgesia fails injection Nalbuphine with dose of 0.1mg/kg per dose will be used as 2nd rescue analgesia. Injection paracetamol 1g IV TDS will be given to all patients considered to be sufficient 1st line analgesia. Patients will be discharged 2 days after surgery when diet and pain will be tolerated. If pain persisted at the time of discharge, oral analgesics will be given for 3 or 4 days. Post operative follow up will be done according to protocol. All information will be recorded on a preformed proforma. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacain | Drug | Bupivacaine with 0.25% of concentration at the end of the operation intraperitoneally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Post operative pain | Intensity of post operative pain by using visual analogue score and frequency of postoperative rescue analgesics if required after instillation of bupivacaine and placebo in both groups. Both outcomes will be noted at different intervals i.e. 2, 6, 12 and 24 hours postoperatively for comparison as mentioned. | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Sardar Umar Rehman, MBBS | Contact | +923319326657 | umersardar578@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Services Institute of Medical Sciences/ Services Hospital Lahore | Recruiting | Lahore | Punjab Province | 54000 | Pakistan |
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| Normal Saline | Other | 10ml of Normal Saline at the end of the operation intraperitoneally. |
|
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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