The Evaluation of the Analgesic Effect of Intraperitoneal Bupivacaine Versus Bupivacaine With Neostigmine on Postoperative Pain in Laparoscopic Cholecystectomy:A Prospective, Randomized, Comparative, Double-blind Study.
Overview
- Phase
- Phase 2
- Intervention
- Bupivacaine Hydrochloride
- Conditions
- Pain, Postoperative
- Sponsor
- Kasr El Aini Hospital
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Time of first analgesic requirements (in hours) after extubation
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Sara Farouk Kassem Habib
lecturer of anesthesiology
Kasr El Aini Hospital
Eligibility Criteria
Inclusion Criteria
- •• American Society of Anaesthesiologist (ASA) I-II.
- •Age 18 - 60 years.
- •Elective laparoscopic cholecystectomy.
- •Body Mass Index (BMI) \<35 (kg/m2).
Exclusion Criteria
- •• Anaphylaxis to local anaesthetics.
- •Anaphylaxis to Neostigmine.
- •American Society of Anaesthesiologist (ASA) III-IV.
- •Chronic pain diseases.
- •Acute cholecystitis.
- •Psychological or nervous system diseases
Arms & Interventions
B group
-Group 1 (Bupivacaine group= B group) will receive a 50 mL solution of bupivacaine 0.25% intraperitoneal instilled solution.
Intervention: Bupivacaine Hydrochloride
BN group
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.
Intervention: Bupivacaine Hydrochloride
BN group
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.
Intervention: Neostigmine
Outcomes
Primary Outcomes
Time of first analgesic requirements (in hours) after extubation
Time Frame: 24 Hours post-operatively.
hours
Secondary Outcomes
- • Total dose of intravenous pethidine (mg/24 hours).(24 hours)
- • The use of intra-operative rescue analgesia.(intraoperative period)
- • The severity of post-operative shoulder pain assessed by visual analogue scale(24 Hours post-operatively.)
- • The severity of post-operative abdominal pain assessed by visual analogue scale(24 hours posoperatively)
- • Post-operative nausea and vomiting assessed by postoperative nausea and vomiting score(24 hours postoperatively)