Clinical Trial of the Use of Intraperitoneal Local Anaesthetic

Imperial College London

Status and phase: Completed; Phase 3

Conditions: Pain, Postoperative

Treatments: Drug: Nebulised Bupivacaine intraperitoneally; Drug: Normal Saline; Other: No Intraperitoneal Therapeutics; Drug: Injected Bupivacaine intraperitoneally

Study type: Interventional

Funder types: Other

Identifiers

NCT00180687

02.CD/218E

Dr. David Peck (Other Identifier)

Prof. Sir Ara Darzi (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 4 patient groups, including a placebo group

Control

Sham Comparator group

Description:

No intraperitoneal therapeutics (No nebulised Bupivacaine)

Treatment:

Other: No Intraperitoneal Therapeutics

IP Aerosolized Normal Saline

Placebo Comparator group

Description:

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

Treatment:

Drug: Normal Saline

Nebulised Bupivacaine intraperitoneally

Experimental group

Description:

Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)

Treatment:

Drug: Nebulised Bupivacaine intraperitoneally

Injected Bupivacaine intraperitoneally

Active Comparator group

Description:

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

Treatment:

Drug: Injected Bupivacaine intraperitoneally