Clinical Trial of the Use of Intraperitoneal Local Anaesthetic

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2005-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Patients undergoing keyhole gall bladder removal will be divided into 3 groups, one control, one will have local anaesthetic and the third will have normal saline nebulised into their abdomen before closure of the wounds to reduce postoperative pain. These medications will be given on top of the standard pain management protocol.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Intraperitoneal Aerosolized Delivery of a Local Anesthetic for Post Operative Pain Management. A Double Blind, Randomised Controlled Clinical Trial.

NCT00286286

Pain, Postoperative Postoperative Pain Abdominal Pain +2 more

UNKNOWN NA

Local Anesthetic Nebulization and Instillation for Pain Control After Laparoscopic Surgery

NCT01248819

Laparoscopic Cholecystectomy

COMPLETED PHASE3

Local Infiltration With Ropivacaine Improves Postoperative Pain Control in Patients

NCT02649179

Postoperative Pain

COMPLETED NA

Local Anesthetics on Postsurgical Analgesia Following Posterior Colporrhaphy

NCT04032327

Postoperative Pain

COMPLETED PHASE2

Local Anesthetic Nebulization for Pain Control After Laparoscopic Cholecystectomy

NCT01247857

Laparoscopic Cholecystectomy

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Pain post laparoscopic procedures can be divided into access related, operation site and distension related. The access type can be attenuated by the use of sub dermal infiltration of local anaesthetic and rarely causes significant discomfort. It has been advocated that placement of a peritoneal gas drain significantly reduces postoperative pain particularly referred to the shoulder tip. Realistically, however, if attention is paid to expelling the residual gas at the end of the procedure this complication is rarely problematic. Operative site pain however is more difficult to manage. In limited gynaecological procedures it has been shown that local installation of local anaesthetic decreased the analgesic requirement of patients post operatively. These observations would not be as transferable to more extensive colorectal or solid organ surgery as the amount of local anaesthesia required would be toxic to the patient. Use of the nebuliser, however maybe able to alleviate pain by efficiently using the dosage required.

This is a prospective randomised double blind trial. Sixty patients will be allocated randomly between three groups, 20 patients in each group:

1. Control group
2. Nebulised intraperitoneal local anaesthetic (Bupivacaine 0.25%, 3mg/Kg)
3. Nebulised intraperitoneal normal saline Ward staff will be blinded to which group the patients are in. All patients undergoing laparoscopic cholecystectomy who have given written, informed consent are eligible for inclusion. Patients with local anaesthetics allergy and patients whom pain evaluation is considered unreliable due to chronic opiate use or neurological diseases are excluded.

No pre-medication is to be given and a standardised anaesthetic technique is to be employed for all patients.

Standard 4 ports technique for laparoscopic cholecystectomy will be used with intraperitoneal pressure between 12-14 mmHg. This will be achieved using CO2 as the insufflation gas.

The local anaesthetic (approximately 10mls) will be delivered via a fine sterile catheter that will be inserted via the epigastric port under direct vision at the end of the procedure. Afterward the pneumoperitoneum will be deflated and the wound will be closed and subcutaneous local anaesthetic will be injected in and around the wounds.

Postoperatively, all the patients will have PCA as the main analgesia supported by NSAIDs unless contraindicated. Patients will eat and drink as desired and drips will be taken as soon as it is safe to do so.

Postoperative pain scoring will be stared in recovery and continue on the wards using the visual analogue scale.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain, Postoperative

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

No intraperitoneal therapeutics (No nebulised Bupivacaine)

Group Type SHAM_COMPARATOR

No Intraperitoneal Therapeutics

Intervention Type OTHER

No Intraperitoneal Therapeutics given

IP Aerosolized Normal Saline

Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

Nebulised Normal Saline

Nebulised Bupivacaine intraperitoneally

Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)

Group Type EXPERIMENTAL

Nebulised Bupivacaine intraperitoneally

Intervention Type DRUG

Nebulised Marcaine (Bupivacaine)

Injected Bupivacaine intraperitoneally

Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)

Group Type ACTIVE_COMPARATOR

Injected Bupivacaine intraperitoneally

Intervention Type DRUG

Injected Marcaine directly into the peritoneal cavity

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nebulised Bupivacaine intraperitoneally

Nebulised Marcaine (Bupivacaine)

Intervention Type DRUG

Normal Saline

Nebulised Normal Saline

Intervention Type DRUG

Injected Bupivacaine intraperitoneally

Injected Marcaine directly into the peritoneal cavity

Intervention Type DRUG

No Intraperitoneal Therapeutics

No Intraperitoneal Therapeutics given

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Marcaine 0.9 % Normal Saline Marcaine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All they patients undergoing laparoscopic cholecystectomy will be included.

Exclusion Criteria

* Patients with local anaesthetic allergy, patients on chronic opiate medication or those with neurological diseases that make pain evaluation unreliable will be excluded.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes