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Injection of intraperitoneal bupivacaine revealed an analgesic effect whether injected alone or in combination with other adjuvants, which increase duration of analgesia and decrease the dose of administered bupivacaine thus minimizing its side effects e.g. Opioids, Corticosteroids and Magnesium sulphate.
Neostigmine, a cholinesterase inhibitor that produces muscarinic receptor-mediated analgesia, increased postoperative analgesia when combined with local anaesthetics. Peripheral afferent nerve fibres contain muscarinic receptors, these could be a good target for pain suppression.
The use of neostigmine as adjuvant to intraperitoneal bupivacaine was not previously investigated. In this study the investigators will compare the analgesic effect of bupivacaine alone and bupivacaine in combination with neostigmine when injected intraperitoneal in patients undergoing laparoscopic cholecystectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B group | Experimental | -Group 1 (Bupivacaine group= B group) will receive a 50 mL solution of bupivacaine 0.25% intraperitoneal instilled solution. |
|
| BN group | Active Comparator | Group 2 (Bupivacaine neostigmine group=BN group) will receive 500 μg neostigmine mixed with bupivacaine 0.25% with a total volume of 50 mL intraperitoneal instilled solution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine Hydrochloride | Drug | after induction of general anesthesia and before the start of surgery, after inflating the pneumoperitoneum and before any surgical manipulation, the surgeon infuse 50 mL of blinded solution (bupivacaine or bupivacaine neostigmine) intraperitoneally to the sub-diaphragmatic space and gall bladder area guided by the camera and the patients are kept in Trendelenburg position for 5-10 minutes. Thereafter all patients will be positioned in the anti-Trendelenburg position to start the surgery and the laparoscopic procedure will be carried out in a standard fashion. |
| Measure | Description | Time Frame |
|---|---|---|
| Time of first analgesic requirements (in hours) after extubation | hours | 24 Hours post-operatively. |
| Measure | Description | Time Frame |
|---|---|---|
| • Total dose of intravenous pethidine (mg/24 hours). | milligram | 24 hours |
| • The use of intra-operative rescue analgesia. | milligram |
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Inclusion Criteria:
• American Society of Anaesthesiologist (ASA) I-II.
Exclusion Criteria:
• Anaphylaxis to local anaesthetics.
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| Name | Affiliation | Role |
|---|---|---|
| Sara Fa Habib, PhD | Kasr El Aini -Faculty Of Medicine- Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sara Farouk Kassem Habib | Cairo | El Azbakeya | 2222 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26957685 | Result | Khurana S, Garg K, Grewal A, Kaul TK, Bose A. A comparative study on postoperative pain relief in laparoscopic cholecystectomy: Intraperitoneal bupivacaine versus combination of bupivacaine and buprenorphine. Anesth Essays Res. 2016 Jan-Apr;10(1):23-8. doi: 10.4103/0259-1162.164731. | |
| Result | LAURETTI G. Postoperative analgesia by intra-articular and epidural neostigmine following knee surgery. Reg Anesth Pain Med [Internet]. 1999 Jun;24(3):17. |
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results of the study or medical data like vital signs only could be shared
2 months after publication
data concerning results charts will be available by contacting principal investigator
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D009388 | Neostigmine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Patients will be randomly allocated to one of two groups with the help of computer generated random number tables in opaque sealed envelopes prepared by an anaesthesiologist not part of the study. The envelops will be opened by the staff nurse, and peritoneal solution will be prepared according to group allocation by anaesthesiologist who is not involved in the study.
|
|
| Neostigmine | Drug | after induction of general anesthesia and before the start of surgery, after inflating the pneumoperitoneum and before any surgical manipulation, the surgeon infuse 50 mL of blinded solution (bupivacaine or bupivacaine neostigmine) intraperitoneally to the sub-diaphragmatic space and gall bladder area guided by the camera and the patients are kept in Trendelenburg position for 5-10 minutes. Thereafter all patients will be positioned in the anti-Trendelenburg position to start the surgery and the laparoscopic procedure will be carried out in a standard fashion. |
|
|
| intraoperative period |
| • The severity of post-operative shoulder pain assessed by visual analogue scale | segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain 0 (no pain), 10(worst pain). The common format is a horizontal bar or line | 24 Hours post-operatively. |
| • The severity of post-operative abdominal pain assessed by visual analogue scale | segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain 0 (no pain), 10(worst pain). The common format is a horizontal bar or line | 24 hours posoperatively |
| • Post-operative nausea and vomiting assessed by postoperative nausea and vomiting score | A simplified risk score for predicting postoperative nausea and vomiting female gender, history of PONV and/or motion sickness, non-smoking status, and postoperative use of opioids. When 0, 1, 2, 3, or 4 factors are present, the risk of postoperative nausea and vomiting is 10%, 20%, 40%, 60%, or 80%, respectively | 24 hours postoperatively |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| D050338 | Phenylammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D009861 | Onium Compounds |