Skip to content

Clinical Trial of the Use of Intraperitoneal Local Anaesthetic

Prospective Double Blind Randomized Controlled Trial of the Use of Intraperitoneal Nebulised Local Anaesthetic

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00180687
Enrollment
80
Registered
2005-09-16
Start date
2004-10-31
Completion date
2005-09-30
Last updated
2015-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

Pain, Nebulisation, Cholecystectomy, Laparoscopic, Bupivacaine, Local Anaesthetic

Brief summary

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.

Detailed 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.

Interventions

DRUGInjected Bupivacaine intraperitoneally

Injected Marcaine directly into the peritoneal cavity

OTHERNo Intraperitoneal Therapeutics

No Intraperitoneal Therapeutics given

DRUGNebulised Bupivacaine intraperitoneally

Nebulised Marcaine (Bupivacaine)

DRUGNormal Saline

Nebulised Normal Saline

Sponsors

Imperial College London
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Reduction in Postoperative Pain0 hours, 6 hours, 12 hours, 24 hoursPostoperative pain was measured using Pain scale 0-10 (0 = No Pain, 10 = Maximum pain). A trained nursing staff will ask the patient about his / her pain and document that correctly in the chart. The staff will also document if the patient requires any analgesia, the type and the dose.

Secondary

MeasureTime frameDescription
Number of Vomiting / Nausea Episodes24 hoursNausea and vomiting are known adverse effect of opioids usage. By reducing the use of opioids we can reduce or abolish these side effect which will enhance early patient recovery and discharge and reduce hospital cost. We will measure the number of episodes when the patient suffers from these side effect and correlate them with opioids use.
Hours Needed for Safe Mobilization24 HoursDrowsiness and delayed mobilization are known adverse effect of opioids usage. By reducing the use of opioids we can reduce or abolish these side effect which will enhance early patient recovery and discharge and reduce hospital cost. We will measure how many hours will take the patient to mobilize freely and safely and correlate them with opioids use.
Postoperative Morphine Use24 HoiursThe reduction in cost comes from reducing the use of opioid which requires nursing supervision and also special pump to be delivered as in the cases of patient controlled analgesia. With that reduction, there will be a reduction in opioid related adverse events that mandate medical or nursing attention and prolong hospitalization, these adverse events include nausea and vomiting, delay mobilization due to drowsiness and alter mental status caused by opioid usage. For these reasons we are collecting data related to these adverse events

Countries

United Kingdom

Participant flow

Participants by arm

ArmCount
Control
No intraperitoneal therapeutics (No nebulised Bupivacaine) No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given
20
IP Aerosolized Normal Saline
Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine) Normal Saline: Nebulised Normal Saline
20
Nebulised Bupivacaine Intraperitoneally
Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine) Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)
20
Injected Bupivacaine Intraperitoneally
Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine) Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity
20
Total80

Baseline characteristics

CharacteristicControlIP Aerosolized Normal SalineNebulised Bupivacaine IntraperitoneallyInjected Bupivacaine IntraperitoneallyTotal
Age, Continuous47.65 Years47.65 Years51.60 Years48.70 Years49 Years
Region of Enrollment
United Kingdom
20 participants20 participants20 participants20 participants80 participants
Sex: Female, Male
Female
16 Participants18 Participants17 Participants18 Participants69 Participants
Sex: Female, Male
Male
4 Participants2 Participants3 Participants2 Participants11 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
5 / 205 / 201 / 205 / 20
serious
Total, serious adverse events
0 / 200 / 200 / 200 / 20

Outcome results

Primary

Reduction in Postoperative Pain

Postoperative pain was measured using Pain scale 0-10 (0 = No Pain, 10 = Maximum pain). A trained nursing staff will ask the patient about his / her pain and document that correctly in the chart. The staff will also document if the patient requires any analgesia, the type and the dose.

Time frame: 0 hours, 6 hours, 12 hours, 24 hours

ArmMeasureGroupValue (MEAN)
ControlReduction in Postoperative PainPain in Recovery (0 Hours)9.2 units on a scale
ControlReduction in Postoperative PainPain at 6 hours8.2 units on a scale
ControlReduction in Postoperative PainPain at 12 hours7.9 units on a scale
ControlReduction in Postoperative PainPain at 24 hours6.1 units on a scale
IP Aerosolized Normal SalineReduction in Postoperative PainPain at 24 hours6.2 units on a scale
IP Aerosolized Normal SalineReduction in Postoperative PainPain at 12 hours8 units on a scale
IP Aerosolized Normal SalineReduction in Postoperative PainPain at 6 hours8.1 units on a scale
IP Aerosolized Normal SalineReduction in Postoperative PainPain in Recovery (0 Hours)10 units on a scale
Nebulised Bupivacaine IntraperitoneallyReduction in Postoperative PainPain at 12 hours0.6 units on a scale
Nebulised Bupivacaine IntraperitoneallyReduction in Postoperative PainPain at 24 hours0.5 units on a scale
Nebulised Bupivacaine IntraperitoneallyReduction in Postoperative PainPain at 6 hours0.7 units on a scale
Nebulised Bupivacaine IntraperitoneallyReduction in Postoperative PainPain in Recovery (0 Hours)3.3 units on a scale
Injected Bupivacaine IntraperitoneallyReduction in Postoperative PainPain at 24 hours5.6 units on a scale
Injected Bupivacaine IntraperitoneallyReduction in Postoperative PainPain in Recovery (0 Hours)9.3 units on a scale
Injected Bupivacaine IntraperitoneallyReduction in Postoperative PainPain at 6 hours7.2 units on a scale
Injected Bupivacaine IntraperitoneallyReduction in Postoperative PainPain at 12 hours6.7 units on a scale
Secondary

Hours Needed for Safe Mobilization

Drowsiness and delayed mobilization are known adverse effect of opioids usage. By reducing the use of opioids we can reduce or abolish these side effect which will enhance early patient recovery and discharge and reduce hospital cost. We will measure how many hours will take the patient to mobilize freely and safely and correlate them with opioids use.

Time frame: 24 Hours

ArmMeasureValue (MEAN)
ControlHours Needed for Safe Mobilization6.7 Hours needed for safe mobilization
IP Aerosolized Normal SalineHours Needed for Safe Mobilization6.5 Hours needed for safe mobilization
Nebulised Bupivacaine IntraperitoneallyHours Needed for Safe Mobilization3 Hours needed for safe mobilization
Injected Bupivacaine IntraperitoneallyHours Needed for Safe Mobilization6.4 Hours needed for safe mobilization
Secondary

Number of Vomiting / Nausea Episodes

Nausea and vomiting are known adverse effect of opioids usage. By reducing the use of opioids we can reduce or abolish these side effect which will enhance early patient recovery and discharge and reduce hospital cost. We will measure the number of episodes when the patient suffers from these side effect and correlate them with opioids use.

Time frame: 24 hours

ArmMeasureValue (MEAN)
ControlNumber of Vomiting / Nausea Episodes7.1 Number of vomitting / Nausea episodes
IP Aerosolized Normal SalineNumber of Vomiting / Nausea Episodes7.1 Number of vomitting / Nausea episodes
Nebulised Bupivacaine IntraperitoneallyNumber of Vomiting / Nausea Episodes2 Number of vomitting / Nausea episodes
Injected Bupivacaine IntraperitoneallyNumber of Vomiting / Nausea Episodes6.8 Number of vomitting / Nausea episodes
Secondary

Postoperative Morphine Use

The reduction in cost comes from reducing the use of opioid which requires nursing supervision and also special pump to be delivered as in the cases of patient controlled analgesia. With that reduction, there will be a reduction in opioid related adverse events that mandate medical or nursing attention and prolong hospitalization, these adverse events include nausea and vomiting, delay mobilization due to drowsiness and alter mental status caused by opioid usage. For these reasons we are collecting data related to these adverse events

Time frame: 24 Hoiurs

ArmMeasureValue (MEAN)
ControlPostoperative Morphine Use25.9 mg
IP Aerosolized Normal SalinePostoperative Morphine Use26.3 mg
Nebulised Bupivacaine IntraperitoneallyPostoperative Morphine Use1 mg
Injected Bupivacaine IntraperitoneallyPostoperative Morphine Use16.7 mg

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026