The Effect of Intraperitoneal Bupivacaine Versus Bupivacaine With Neostigmine on Pain in Laparoscopic Cholecystectomy (RCTcompstud)

Kasr El Aini Hospital

Status and phase: Completed; Phase 2

Conditions: Pain, Postoperative

Treatments: Drug: Bupivacaine Hydrochloride; Drug: Neostigmine

Study type: Interventional

Funder types: Other

Identifiers

NCT04244097

MS-273-2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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56 participants in 2 patient groups

B group

Experimental group

Description:

-Group 1 (Bupivacaine group= B group) will receive a 50 mL solution of bupivacaine 0.25% intraperitoneal instilled solution.

Treatment:

Drug: Bupivacaine Hydrochloride

BN group

Active Comparator group

Description:

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.

Treatment:

Drug: Neostigmine

Drug: Bupivacaine Hydrochloride