Postoperative PainLIVERNCT01042054
Comparison of Analgesic Methods, and Their Effects on Patient Recovery, Following Liver Surgery
A study testing Standard optimised recovery protocol. in people with Postoperative Pain, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
The provision of adequate pain relief following major liver surgery is essential, not only for patient comfort, but for the prevention of complications, such as chest infection. Commonly, pain relief in the first few days after surgery is provided by epidural analgesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Standard optimised recovery protocol.
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2009to Jul 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing open hepatic resection for benign or malignant conditions.
- Able to understand the nature of the study and what will be required of them.
- Men and non-pregnant, non-lactating women.
- BMI 18-40.
Who cannot join
- Patients with contraindication to either epidural or wound catheter techniques.
- Inability to give written, informed consent.
- Patients with dementia or neurological impairment.
- Patients with pre-existing condition limiting mobility.
- Underlying cirrhotic liver disease.
- Jaundice (Bilirubin > 50 μmol/L).
- Liver resection combined with secondary surgical procedure.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Surgery, Royal Infirmary of Edinburgh
Edinburgh, Midlothian, EH16 4SA
About this study
Official title: The Effects of Local Infiltration Versus Epidural on Recovery
The provision of adequate pain relief following major liver surgery is essential, not only for patient comfort, but for the prevention of complications, such as chest infection.
Commonly, pain relief in the first few days after surgery is provided by epidural analgesia. Drugs are delivered to the area around the spinal cord, through a fine plastic tube placed in the patients back, and this blocks sensation from the abdomen downwards, thereby providing effective pain relief without the need for opiate analgesia (e.g. morphine). Opiate analgesia can cause nausea, drowsiness and constipation, and its use should be minimised. Epidurals, however, can be associated with some problematic side effects. Low blood pressure is commonly encountered, and not only can its treatment be associated with complications, but patients are often confined to bed.
Read more
Mobility can also be limited if muscle function in the legs, (in addition to sensation), is inadvertently affected by the epidural drugs. Other problems associated with epidural use are the relatively common failure of the technique to provide adequate analgesia (20%), and some extremely rare but potentially disastrous complications of epidural insertion.
An alternative technique, is the provision of pain relief directly into the wound, via one or more multi-holed tubes(catheters), placed either in or close to the wound. This technique alone does not provide as effective analgesia as a functioning epidural, but when combined with other intravenous or oral analgesia, has been shown to be effective following a variety of surgical procedures.
It is hypothesised that, following major liver surgery, the use of this latter technique may result in superior outcome and faster recovery, when compared with epidural, by avoidance of the side effects and complications discussed above.
In this study, patients scheduled to undergo major liver surgery at the Royal Infirmary of Edinburgh with be randomly assigned to receive the first two days of pain relief either by epidural, or by wound catheter plus additional analgesia. Both groups will then receive an identical oral analgesic regime for the remainder of the hospital stay.
Outcomes of interest will include the quality of pain relief attained, patient mobility, frequency of complications, and overall recovery time.
- Conditions
- Postoperative Pain
- Being tested
- Standard optimised recovery protocol., Wound catheter plus patient-controlled analgesia.
- Keywords
- Postoperative Care, Enhanced, Recovery, Hepatectomy, Analgesia
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard optimised recovery protocol.Other
- Epidural analgesia for the first 48 hours postoperatively.
- Sham wound catheter attached to anterior abdominal wall, for purposes of blinding.
- Standard oral analgesic regime commenced at 48 hours, and continued until discharge from hospital.
- Optimised recovery protocol followed throughout.
Wound catheter plus patient-controlled analgesia.Other
Also called ON-Q PainBuster
- Continuous infusion of local anaesthetic administered via wound catheters for the first 48 hours postoperatively.
- Additional patient-controlled intravenous opiate analgesia available to patient during this time period.
- Sham epidural catheter applied to the patient's back for purposes of blinding.
- Standard oral analgesic regime commenced at 48 hours, and continued until discharge from hospital.
- Optimised recovery protocol followed throughout.
| Study group | Role | What they receive |
|---|---|---|
| Epidural | Active comparator | Patients will follow a standard optimised recovery protocol, including epidural analgesia for the first 48 hours postoperatively. Receives: Other: Standard optimised recovery protocol. |
| Wound catheter | Experimental | Patients will follow a standard optimised recovery protocol, but analgesia in the first 48 hours will be delivered through local anaesthetic wound catheters and additional patient-controlled analgesia, instead of epidural analgesia. Receives: Other: Wound catheter plus patient-controlled analgesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of time to reach criteria for discharge from hospital.
Measured: This will be assessed twice daily until criteria for dicharge from hospital are met.
Secondary outcomes (8)
Pain scores, assessed using numerical rating score (0 to 10).
Measured: Assessed at 2, 6 & 12 hours following closure of wound, and daily thereafter until discharge from hospital, or day 7, whichever is sooner.
Nausea and sedation scores, assessed using numerical rating score (0 to 3).
Measured: Assessed at 2, 6 & 12 hours following closure of wound, and daily thereafter until discharge from hospital, or day 7, whicever is sooner.
Sleep disturbance, assessed using numerical rating score (0 to 10).
Measured: Assessed daily from the morning following surgery until discharge from hospital, or day 7, whichever is sooner.
Volume of intravenous fluids received in the first 48 hours following operation (ml).
Measured: Data collected daily for first 48 hours following operation.
Mobility (percentage of time spent lying / sitting, standing or walking, as measured by ActivPAL meter).
Measured: From the end of the operative procedure until discharge from hospital, or day 7, whichever is sooner.
Time to return of bowel function (days).
Measured: Assessed daily until return of bowel function.
Length of time to meet criteria for discharge from the High Dependency Unit.
Measured: Assessed twice daily until criteria for discharge from the High Dependency Unit met.
Complications (General and Technical).
Measured: Assessed daily throughout hospital admission, and at outpatient review clinic 4-6 weeks following discharge from hospital.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2010 (estimated)
- Study startJul 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Principal investigator, Erica Revie, University of Edinburgh
- Investigators
- Erica J Revie, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01042054
- Sponsor's protocol ID
- 09/S1102/17
- Other IDs
- 2009/R/SU/04
- Acronym
- LIVER
- Status last verified
- Mar 2015
- First submitted
- 4 Jan 2010
- Last updated
- 13 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Revie EJ, McKeown DW, Wilson JA, Garden OJ, Wigmore SJ. Randomized clinical trial of local infiltration plus patient-controlled opiate analgesia vs. epidural analgesia following liver resection surgery. HPB (Oxford). 2012 Sep;14(9):611-8. doi: 10.1111/j.1477-2574.2012.00490.x. Epub 2012 Jun 10.
PubMed 22882198
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Local Infiltration Versus Epidural on Recovery
- ClinicalTrials.gov ID
- NCT01042054
- Acronym / sponsor ID
- LIVER / 09/S1102/17
- Conditions
- Postoperative Pain
- Keywords
- Postoperative Care, Enhanced, Recovery, Hepatectomy, Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- Jul 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 5 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The provision of adequate pain relief following major liver surgery is essential, not only for patient comfort, but for the prevention of complications, such as chest infection.
Commonly, pain relief in the first few days after surgery is provided by epidural analgesia. Drugs are delivered to the area around the spinal cord, through a fine plastic tube placed in the patients back, and this blocks sensation from the abdomen downwards, thereby providing effective pain relief without the need for opiate analgesia (e.g. morphine). Opiate analgesia can cause nausea, drowsiness and constipation, and its use should be minimised. Epidurals, however, can be associated with some problematic side effects. Low blood pressure is commonly encountered, and not only can its treatment be associated with complications, but patients are often confined to bed.
Mobility can also be limited if muscle function in the legs, (in addition to sensation), is inadvertently affected by the epidural drugs. Other problems associated with epidural use are the relatively common failure of the technique to provide adequate analgesia (20%), and some extremely rare but potentially disastrous complications of epidural insertion.
An alternative technique, is the provision of pain relief directly into the wound, via one or more multi-holed tubes(catheters), placed either in or close to the wound. This technique alone does not provide as effective analgesia as a functioning epidural, but when combined with other intravenous or oral analgesia, has been shown to be effective following a variety of surgical procedures.
It is hypothesised that, following major liver surgery, the use of this latter technique may result in superior outcome and faster recovery, when compared with epidural, by avoidance of the side effects and complications discussed above.
In this study, patients scheduled to undergo major liver surgery at the Royal Infirmary of Edinburgh with be randomly assigned to receive the first two days of pain relief either by epidural, or by wound catheter plus additional analgesia. Both groups will then receive an identical oral analgesic regime for the remainder of the hospital stay.
Outcomes of interest will include the quality of pain relief attained, patient mobility, frequency of complications, and overall recovery time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural | Active comparator | Other: Standard optimised recovery protocol.Patients will follow a standard optimised recovery protocol, including epidural analgesia for the first 48 hours postoperatively. |
| Wound catheter | Experimental | Other: Wound catheter plus patient-controlled analgesia.Patients will follow a standard optimised recovery protocol, but analgesia in the first 48 hours will be delivered through local anaesthetic wound catheters and additional patient-controlled analgesia, instead of epidural analgesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing open hepatic resection for benign or malignant conditions.
- Able to understand the nature of the study and what will be required of them.
- Men and non-pregnant, non-lactating women.
- BMI 18-40.
Key exclusion criteria (7 listed)
- Patients with contraindication to either epidural or wound catheter techniques.
- Inability to give written, informed consent.
- Patients with dementia or neurological impairment.
- Patients with pre-existing condition limiting mobility.
- Underlying cirrhotic liver disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard optimised recovery protocol.* Epidural analgesia for the first 48 hours postoperatively. * Sham wound catheter attached to anterior abdominal wall, for purposes of blinding. * Standard oral analgesic regime commenced at 48 hours, and continued until discharge from hospital. * Optimised recovery protocol followed throughout. | Other | Epidural |
| Wound catheter plus patient-controlled analgesia.Also: ON-Q PainBuster* Continuous infusion of local anaesthetic administered via wound catheters for the first 48 hours postoperatively. * Additional patient-controlled intravenous opiate analgesia available to patient during this time period. * Sham epidural catheter applied to the patient's back for purposes of blinding. * Standard oral analgesic regime commenced at 48 hours, and continued until discharge from hospital. * Optimised recovery protocol followed throughout. | Other | Wound catheter |
Primary outcome
Length of time to reach criteria for discharge from hospital.
Time frame: This will be assessed twice daily until criteria for dicharge from hospital are met.
8 secondary outcomes
Pain scores, assessed using numerical rating score (0 to 10).
Time frame: Assessed at 2, 6 & 12 hours following closure of wound, and daily thereafter until discharge from hospital, or day 7, whichever is sooner.
Nausea and sedation scores, assessed using numerical rating score (0 to 3).
Time frame: Assessed at 2, 6 & 12 hours following closure of wound, and daily thereafter until discharge from hospital, or day 7, whicever is sooner.
Sleep disturbance, assessed using numerical rating score (0 to 10).
Time frame: Assessed daily from the morning following surgery until discharge from hospital, or day 7, whichever is sooner.
Volume of intravenous fluids received in the first 48 hours following operation (ml).
Time frame: Data collected daily for first 48 hours following operation.
Mobility (percentage of time spent lying / sitting, standing or walking, as measured by ActivPAL meter).
Time frame: From the end of the operative procedure until discharge from hospital, or day 7, whichever is sooner.
Time to return of bowel function (days).
Time frame: Assessed daily until return of bowel function.
Length of time to meet criteria for discharge from the High Dependency Unit.
Time frame: Assessed twice daily until criteria for discharge from the High Dependency Unit met.
Complications (General and Technical).
Time frame: Assessed daily throughout hospital admission, and at outpatient review clinic 4-6 weeks following discharge from hospital.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2015.
- Derived from this study: PubMed 22882198Revie EJ, McKeown DW, Wilson JA, Garden OJ, Wigmore SJ. Randomized clinical trial of local infiltration plus patient-controlled opiate analgesia vs. epidural analgesia following liver resection surgery. HPB (Oxford). 2012 Sep;14(9):611-8. doi: 10.1111/j.1477-2574.2012.00490.x. Epub 2012 Jun 10.
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erica J Revie principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard optimised recovery protocol. in people with Postoperative Pain, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of time to reach criteria for discharge from hospital. (time frame: This will be assessed twice daily until criteria for dicharge from hospital are met.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01042054, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2015.