Feasibility Study on Pain Control After Laparoscopic Cholecystectomy

April 27, 2021 updated by: Royal Devon and Exeter NHS Foundation Trust

Is it Feasible to Conduct a Randomised Controlled Trial (RCT) of the Transverse Abdominis Plane (TAP) Block Versus Anaesthetic Injections to the Wound Site for Patients Requiring Laparoscopic Cholecystectomy?

The objective of the study is to hopefully understand the most beneficial way to control pain after removing the gallbladder by keyhole surgery (laparoscopic cholecystectomy).

The investigators will investigate two groups of patients undergoing laparoscopic cholecystectomy.

One group will receive the injection of local anaesthetic into the abdominal wall (TAP block) and into the wounds; the second group will have local anaesthetic into the wounds only.

In order to have meaningful results, we anticipate a large number of participants would be required. Therefore we would test first whether it is technically possible to set up the study itself.

The investigators will be looking at parameters (willingness of patients to be recruited, willingness of clinicians to recruit participants, number of eligible patients, follow-up rates, adherence/compliance rates, number of participants needed for an adequate sample size) that will allow to understand if such a larger trial is technically possible to set up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pain control after laparoscopic cholecystectomy can be achieved with the injection of local anaesthetic into the abdominal wall (TAP block) or into the surgical wounds. There is no reported literature comparing the two techniques with regard to early discharge rate, consumption of oral painkillers and return to daily activities in the week following surgery. In an era where day case surgery has become reality, there is a pressing need for strategies to optimize patients' pathways. In this context the postoperative pain control is a key point.

To compare the two techniques in a randomized trial, a large number of participants would be needed. Therefore the investigators would conduct a pilot study first, to evaluate if further research in the form of a larger study is likely to demonstrate the benefits of the TAP block during laparoscopic cholecystectomy.

During the developing of the research proposal, advice and comments had been given by the local Research and Development Department and the public.

Recruitment

Clinicians will identify potential participants in the surgical outpatient clinic. All patients who fulfil the entry criteria will be invited to take part in the study.

Participants will be fully informed verbally about the proposed study and will receive a Letter of invitation to participant and a Patient information leaflet to take home. That will give them adequate time to read the documents and make an informed choice.

Sample size

As being a feasibility study it is required to have 30 cases per group in the final dataset, with a total of 60 patients.

Consent

Patients will be informed about the study and receive the information leaflet at the time they are enrolled for an elective laparoscopic cholecystectomy in the surgical outpatient clinic. Only once patients are fully informed will they be asked to make a decision to enter the trial. Participants willing to join the study will have written informed consent, on the day of surgery.

Patients will be informed that they do not have to take part in the study if they choose to not be enrolled. Refusal to enter the trial will not compromise their care. Patients will also be informed that if at any time during the study they wish to withdraw they can do so, without having to give a reason and again this will not compromise their care. General Pratictioners will be informed by letter of their patients' inclusion in the study.

Risks and Benefits

There are no additional risks over and above participants' normal clinical care.

Both anaesthetic techniques are currently in use in the Royal Devon and Exeter National Heath System Foundation Trust. The procedures themselves do have potential risks (side-effects) which would be explained routinely to both trial and non-trial patients ahead of surgery. Taking part in this study will not change these risks in any way.

There are no immediate benefits to the participants from taking part in the trial at present. However, if the results are promising, the investigators will run a larger trial that could potentially lead to a new way of looking after patients having laparoscopic cholecystectomy.

That may therefore lead to a future change in medical care that could help patients who will be having laparoscopic cholecystectomy.

The investigators would be clear that no new technique or medication is being tested. Also there is no financial benefit from the study to both the participants and the research team.

Conflicts of Interest

None.

Confidentiality

All data will be stored anonymously against a participant number. Only the clinical team and research nurse will have access to the single table correlating participant's name number. Anonymity will be preserved throughout the trial.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Exeter, United Kingdom, EX25DW
        • Royal Devon and Exeter NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients able/willing to give informed consent for participation in the study.
  • Male or female aged 18-60 years old.

Exclusion Criteria:

  • Patients having an open cholecystectomy (performed through the standard "rope" incision).
  • Patients intended to have laparoscopic cholecystectomy as an inpatient (staying overnight after surgery).
  • Patients initially scheduled to have day case surgery but eventually admitted to hospital due to surgical or anaesthetic concerns or social reasons.
  • Patients with contraindications in having injection of the local anaesthetic used in the study (i.e. history of side-effects, allergy).
  • Patients who cannot have one or more standard oral painkillers prescribed postoperatively.
  • Patients with history of chronic pain who are already on long term painkillers.
  • Patients unable/unwilling to give informed consent for participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TAP block
Patients receive the injection of local anaesthetic into the right abdominal wall (TAP block) together with the injection of local anaesthetic into the surgical wounds.
Drug: TAP Block
Injection of Bupivacaine 0.5% 20 ml into the thickness of the right abdominal wall and of Bupivacaine 0.5% 10 ml into the surgical wounds.
Other Names:
  • Bupivacaine 0.5%
Other: Control
Patients receive the injection of local anaesthetic into the surgical wounds only.
Drug: Control
Injection of Bupivacaine 0.5% 10 ml into the surgical wounds
Other Names:
  • Bupivacaine 0.5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total amount number of patients who give their consent to take part to the study
Time Frame: 24 months
Overall ability to recruit participants
24 months
Total number of questionnaire responses
Time Frame: 24 months
Ability to follow-up participants
24 months
Total number of number of patients adhering to follow-up
Time Frame: 24 months
Ability to collect adequate data
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Standard deviation (SD) of hospital stay between the two study arms
Time Frame: 24 months
To understand if the intervention significantly impacts the length of hospital stay
24 months
Standard deviation (SD) of questionnaire scores between the two study arms
Time Frame: 24 months
To understand if the intervention significantly impacts the scores on the follow-up questionnaire
24 months
Standard deviation (SD) of costs (hospital stay and prescription of painkillers) between the two study arms
Time Frame: 24 months
To understand if the intervention significantly yields a financial benefit
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Devon and Exeter NHS Foundation Trust

Investigators

  • Principal Investigator: Antonio Manzelli, MD, PhD, Royal Devon and Exeter NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Actual)

April 26, 2021

Study Completion (Actual)

April 26, 2021

Study Registration Dates

First Submitted

April 27, 2018

First Submitted That Met QC Criteria

May 21, 2018

First Posted (Actual)

May 22, 2018

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1901750

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

It is a feasibility study therefore sharing of individual participant data is not considered for further studies.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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