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

NCT04244097 | Completed Phase 2

• 1 other identifier: MS-273-2019
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Time of first analgesic requirements (in hours) after extubation

  hours

  24 Hours post-operatively.

Secondary Outcomes (5)

• • 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

Study Arms (2)

B group

EXPERIMENTAL

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

Drug: Bupivacaine Hydrochloride

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.

Drug: Bupivacaine Hydrochloride; Drug: Neostigmine

Interventions

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.

Also known as: Marcaine

B group; BN group

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.

Also known as: prostigmin

BN group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anaesthesiologist (ASA) I-II.
• Age 18 - 60 years.
• Elective laparoscopic cholecystectomy.
• Body Mass Index (BMI) \<35 (kg/m2).

You may not qualify if:

• Anaphylaxis to local anaesthetics.
• Anaphylaxis to Neostigmine.
• American Society of Anaesthesiologist (ASA) III-IV.
• Chronic pain diseases.
• Acute cholecystitis.
• Psychological or nervous system diseases

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Sara Farouk Kassem Habib

Cairo, El Azbakeya, 2222, Egypt

Location

Related Publications (2)

• 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.

  PMID: 26957685 RESULT

• LAURETTI G. Postoperative analgesia by intra-articular and epidural neostigmine following knee surgery. Reg Anesth Pain Med [Internet]. 1999 Jun;24(3):17.

  RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Neostigmine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylammonium Compounds; Quaternary Ammonium Compounds; Onium Compounds

Study Officials

• Sara Fa Habib, PhD

  Kasr El Aini -Faculty Of Medicine- Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesiology

Model Details: * 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.

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: January 28, 2020
• Study Start: April 10, 2020
• Primary Completion: July 6, 2020
• Study Completion: August 6, 2020
• Last Updated: September 3, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 2 months after publication
• Access Criteria: data concerning results charts will be available by contacting principal investigator

Locations

EG (1)