The Effect of Intraperitoneal Bupivacaine Versus Bupivacaine With Neostigmine on Pain in Laparoscopic Cholecystectomy
- Conditions
- Pain, Postoperative
- Interventions
- Registration Number
- NCT04244097
- Lead Sponsor
- Kasr El Aini Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
-
• American Society of Anaesthesiologist (ASA) I-II.
- Age 18 - 60 years.
- Elective laparoscopic cholecystectomy.
- Body Mass Index (BMI) <35 (kg/m2).
-
• Anaphylaxis to local anaesthetics.
- Anaphylaxis to Neostigmine.
- American Society of Anaesthesiologist (ASA) III-IV.
- Chronic pain diseases.
- Acute cholecystitis.
- Psychological or nervous system diseases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B group Bupivacaine Hydrochloride -Group 1 (Bupivacaine group= B group) will receive a 50 mL solution of bupivacaine 0.25% intraperitoneal instilled solution. BN group Bupivacaine Hydrochloride 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. BN group Neostigmine 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.
- Primary Outcome Measures
Name Time Method Time of first analgesic requirements (in hours) after extubation 24 Hours post-operatively. hours
- Secondary Outcome Measures
Name Time Method • Total dose of intravenous pethidine (mg/24 hours). 24 hours milligram
• The use of intra-operative rescue analgesia. intraoperative period milligram
• The severity of post-operative shoulder pain assessed by visual analogue scale 24 Hours post-operatively. 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
• The severity of post-operative abdominal pain assessed by visual analogue scale 24 hours posoperatively 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
• Post-operative nausea and vomiting assessed by postoperative nausea and vomiting score 24 hours postoperatively 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
Trial Locations
- Locations (1)
Sara Farouk Kassem Habib
🇪🇬Cairo, El Azbakeya, Egypt