Clinical trial NCT04244097: The Effect of Intraperitoneal Bupivacaine Versus Bupivacaine With Neostigmine on Pain in Laparoscopic Cholecystectomy
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain, Postoperative
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * Group 1 (Bupivacaine group= B group) will receive a 50 mL solution of bupivacaine 0.25% intraperitoneal instilled solution.
* 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 purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time of first analgesic requirements (in hours) after extubation
timeFrame: 24 Hours post-operatively.
Secondary outcomes:
measure: • Total dose of intravenous pethidine (mg/24 hours).
timeFrame: 24 hours
measure: • The use of intra-operative rescue analgesia.
timeFrame: intraoperative period
measure: • The severity of post-operative shoulder pain assessed by visual analogue scale
timeFrame: 24 Hours post-operatively.
measure: • The severity of post-operative abdominal pain assessed by visual analogue scale
timeFrame: 24 hours posoperatively
measure: • Post-operative nausea and vomiting assessed by postoperative nausea and vomiting score
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Sara Farouk Kassem Habib
state: El Azbakeya
Study officials:
affiliation: Kasr El Aini -Faculty Of Medicine- Cairo University
name: Sara Fa Habib, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: LAURETTI G. Postoperative analgesia by intra-articular and epidural neostigmine following knee surgery. Reg Anesth Pain Med [Internet]. 1999 Jun;24(3):17.