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

Pain, Postoperative Clinical Trial

— RCTcompstud  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04244097
• Other study ID #: MS-273-2019
• Status: Completed
• Phase: Phase 2
• Start date: April 10, 2020
• Est. completion date: August 6, 2020

Study information

• Verified date: September 2020
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: August 6, 2020
• Est. primary completion date: July 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Bupivacaine Hydrochloride
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.
• Neostigmine
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.

Locations

Country	Name	City	State
Egypt	Sara Farouk Kassem Habib	Cairo	El Azbakeya

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

References & 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. do — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of first analgesic requirements (in hours) after extubation	hours	24 Hours post-operatively.
Secondary	• Total dose of intravenous pethidine (mg/24 hours).	milligram	24 hours
Secondary	• The use of intra-operative rescue analgesia.	milligram	intraoperative period
Secondary	• The severity of post-operative shoulder pain assessed by visual analogue scale	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	24 Hours post-operatively.
Secondary	• The severity of post-operative abdominal pain assessed by visual analogue scale	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	24 hours posoperatively
Secondary	• Post-operative nausea and vomiting assessed by postoperative nausea and vomiting score	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	24 hours postoperatively