SurgeryNCT02700217
Does Adding Spinal Anaesthesia to a General Anaesthetic Technique Influence Readiness for Discharge in Patients Having Hand Assisted Laparoscopic Live Donor Nephrectomy
A study testing Bupivacaine and Diamorphine, Remifentanil, Propofol and Cistracurium and Bupivacaine and Rectus Sheath injection in people with Surgery, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
About 1100 living donor nephrectomies are performed in the UK every year contributing to almost 35% of all the kidney transplants. Laparoscopic surgical techniques are general employed for donor nephrectomy as they are associated with a shorter hospital stay and faster return to normal physical functioning. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Surgery
- What is being tested?
- Bupivacaine and Diamorphine, Remifentanil, Propofol and Cistracurium and Bupivacaine and Rectus Sheath injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Mar 2016to 5 Mar 2019
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1-2 status
- Patients aged between 18-65 years
Who cannot join
- Patient refusal
- Pregnancy
- Allergy to bupivacaine
- Patients who have had previous abdominal surgery
- Patients having chronic pain or any medications for chronic pain
- Any patient in whom spinal anaesthesia is contra-indicated
- Patients on anti-platelet or anti-thrombotic therapy.
- Patient requiring interpreter
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Central Manchester University Hospitals NHS Foundation Trust
Manchester, M13 9WL
About this study
About 1100 living donor nephrectomies are performed in the UK every year contributing to almost 35% of all the kidney transplants. Laparoscopic surgical techniques are general employed for donor nephrectomy as they are associated with a shorter hospital stay and faster return to normal physical functioning. Local anaesthetic infiltration technique with or without spinal anaesthesia in combination with a general anaesthetic is increasingly being used as part of enhanced recovery programme across general surgery. The impact of combined spinal and general anaesthesia along with local infiltration and rectus sheath blocks on acute pain has not been studied in patients undergoing hand assisted laparoscopic live donor nephrectomy.
The investigators plan to investigate whether adding a spinal anaesthetic to a conventional general anaesthetic technique actually influences clinical outcomes of length of hospital stay and acute pain in patients undergoing hand assisted laparoscopic live donor nephrectomy.
The investigators plan to randomise 90 patients undergoing hand assisted laparoscopic live donor nephrectomy over 24 month period at Central Manchester University hospitals and divide them in two groups of 45 each. Group A will receive a general anaesthetic (GA) with spinal anaesthesia (Spinal group) and Group B will receive a GA with a rectus sheath block (Rectus sheath group) and local anaesthetic infiltration
- Conditions
- Surgery
- Being tested
- Bupivacaine and Diamorphine, Remifentanil, Propofol and Cistracurium, Bupivacaine and Rectus Sheath injection
- Keywords
- Donor Nephrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine and DiamorphineProcedure or surgery
Remifentanil, Propofol and CistracuriumProcedure or surgery
Bupivacaine and Rectus Sheath injectionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Spinal Anaesthesia | Experimental | 2.5ml of heavy 0.5% Bupivacaine, 400mg of Diamorphine (Spinal Anaesthesia) \& IV infusion of Remifentanil 0.2-0.3ug/kg/min, Propofol 2-3mg/kg and 0.2 mg/kg of Cistracurium (General Anaesthesia) Receives: Procedure: Bupivacaine and Diamorphine; Procedure: Remifentanil, Propofol and Cistracurium |
| Rectus Sheath Injection | Active comparator | 50ml of 0.25% I-Bupivacaine max 2mg/kg (IV block Anaesthesia) injected into rectus sheath bilaterally \& IV infusion of Remifentanil 0.2-0.3ug/kg/min, Propofol 2-3mg/kg and 0.2 mg/kg of Cistracurium (General Anaesthesia) Receives: Procedure: Remifentanil, Propofol and Cistracurium; Procedure: Bupivacaine and Rectus Sheath injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of readiness for discharge from hospital to determine Length of stay, after renal surgery, using a blinded Nurse assessment of patient.
From Day 2 a nurse blinded to both groups will assess the readiness for discharge at 10:00, 14:00 and at 18:00 hours. The patient would be considered suitable for discharge if the following criteria are met:
(i) Able to get in and out of bed, (ii) Able to get dressed, (iii) Able to go to toilet without walking aids, (iv) Pain manageable with oral analgesics, (v) Patient willing to be discharged.
Length of stay (LOS) would be calculated as the time from the end of surgery until the subject met the discharge criteria from the ward. The actual day and time the patient leaves the hospital would be noted as well.
Measured: 5 days
Secondary outcomes (5)
Assessment of Pain from surgery to discharge tested at intervals using an 11 point linear numerical rating scale utilised for assessment of pain.
Pain scores at rest and on movement along with PONV scores with anti-emetics will be assessed thrice daily at 10:00, 14:00 and 18:00 on Day 1. Total oxycodone consumption in the first 24 hours after surgery will be noted.
In the ward, the pain scores at rest and at movement would be assessed at 3, 6, 12 and 24 hours from the end of surgery using the NRS scoring system by a nurse who would be blinded to both the groups.
Measured: 5 days
The total patient controlled analgesia (PCA) morphine consumption
Measured: 5 days
Assessing the side effects of the anaesthetic technique specifically looking at PDPH throughout the recovery process in hospital, using the PONV
Assessing the side effects of the anaesthetic technique specifically looking at vasopressor use peri-operatively, postoperative nausea and vomiting, post dural puncture headache (PDPH) and urinary re-catherisation rates throughout the recovery process in hospital, using the Postoperative nausea and vomiting scale (PONV).
Measured: 5 days
Assessing the side effects of the anaesthetic technique specifically looking at PDPH throughout the recovery process in hospital, using the VAS
Assessing the side effects of the anaesthetic technique specifically looking at vasopressor use peri-operatively, postoperative nausea and vomiting, post dural puncture headache (PDPH) and urinary re-catherisation rates throughout the recovery process in hospital, using the Visual analogue Scale (VAS) for nausea anchored with 'no nausea' and 'worst possible nausea'.
Measured: 5 days
Assessment of Patient Satisfaction using the Patient Anaesthesia Satisfaction Scale (PASS)
Before leaving the hospital, all patients would be asked to rate the anaesthesia and the pain relief they had received on a 100 mm scale where 0=worst imaginable experience and 100 =best possible experience.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study start16 Mar 2016
- Primary completion5 Mar 2019
- Study completion5 Mar 2019
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 SurgeryStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700217
- Sponsor's protocol ID
- R04134
- Status last verified
- Mar 2020
- First submitted
- 9 Feb 2016
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Bhatia K, Columb M, Wadsworth R, Macnab W, Jepegnanam C, Campbell T, Van Dellen D. Effect of rectus sheath block vs. spinal anaesthesia on time-to-readiness for hospital discharge after trans-peritoneal hand-assisted laparoscopic live donor nephrectomy: A randomised trial. Eur J Anaesthesiol. 2021 Apr 1;38(4):374-382. doi: 10.1097/EJA.0000000000001337.
PubMed 33009185
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Adding Spinal Anaesthesia to a General Anaesthetic Technique Influence Readiness for Discharge in Patients Having Hand Assisted Laparoscopic Live Donor Nephrectomy
- ClinicalTrials.gov ID
- NCT02700217
- Acronym / sponsor ID
- R04134
- Conditions
- Surgery
- Keywords
- Donor Nephrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Study start
- 16 Mar 2016 (actual)
- Primary completion
- 5 Mar 2019 (actual)
- Study completion
- 5 Mar 2019 (actual)
- First posted
- 7 Mar 2016 (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.
About 1100 living donor nephrectomies are performed in the UK every year contributing to almost 35% of all the kidney transplants. Laparoscopic surgical techniques are general employed for donor nephrectomy as they are associated with a shorter hospital stay and faster return to normal physical functioning. Local anaesthetic infiltration technique with or without spinal anaesthesia in combination with a general anaesthetic is increasingly being used as part of enhanced recovery programme across general surgery. The impact of combined spinal and general anaesthesia along with local infiltration and rectus sheath blocks on acute pain has not been studied in patients undergoing hand assisted laparoscopic live donor nephrectomy.
The investigators plan to investigate whether adding a spinal anaesthetic to a conventional general anaesthetic technique actually influences clinical outcomes of length of hospital stay and acute pain in patients undergoing hand assisted laparoscopic live donor nephrectomy.
The investigators plan to randomise 90 patients undergoing hand assisted laparoscopic live donor nephrectomy over 24 month period at Central Manchester University hospitals and divide them in two groups of 45 each. Group A will receive a general anaesthetic (GA) with spinal anaesthesia (Spinal group) and Group B will receive a GA with a rectus sheath block (Rectus sheath group) and local anaesthetic infiltration
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal Anaesthesia | Experimental | Procedure: Bupivacaine and Diamorphine, Procedure: Remifentanil, Propofol and Cistracurium2.5ml of heavy 0.5% Bupivacaine, 400mg of Diamorphine (Spinal Anaesthesia) \& IV infusion of Remifentanil 0.2-0.3ug/kg/min, Propofol 2-3mg/kg and 0.2 mg/kg of Cistracurium (General Anaesthesia) |
| Rectus Sheath Injection | Active comparator | Procedure: Remifentanil, Propofol and Cistracurium, Procedure: Bupivacaine and Rectus Sheath injection50ml of 0.25% I-Bupivacaine max 2mg/kg (IV block Anaesthesia) injected into rectus sheath bilaterally \& IV infusion of Remifentanil 0.2-0.3ug/kg/min, Propofol 2-3mg/kg and 0.2 mg/kg of Cistracurium (General Anaesthesia) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA 1-2 status
- Patients aged between 18-65 years
Key exclusion criteria (8 listed)
- Patient refusal
- Pregnancy
- Allergy to bupivacaine
- Patients who have had previous abdominal surgery
- Patients having chronic pain or any medications for chronic pain
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 |
|---|---|---|
| Bupivacaine and Diamorphine | Procedure or surgery | Spinal Anaesthesia |
| Remifentanil, Propofol and Cistracurium | Procedure or surgery | Rectus Sheath Injection, Spinal Anaesthesia |
| Bupivacaine and Rectus Sheath injection | Procedure or surgery | Rectus Sheath Injection |
Primary outcome
Assessment of readiness for discharge from hospital to determine Length of stay, after renal surgery, using a blinded Nurse assessment of patient.
Time frame: 5 days
From Day 2 a nurse blinded to both groups will assess the readiness for discharge at 10:00, 14:00 and at 18:00 hours. The patient would be considered suitable for discharge if the following criteria are met: (i) Able to get in and out of bed, (ii) Able to get dressed, (iii) Able to go to toilet without walking aids, (iv) Pain manageable with oral analgesics, (v) Patient willing to be discharged. Length of stay (LOS) would be calculated as the time from the end of surgery until the subject met the discharge criteria from the ward. The actual day and time the patient leaves the hospital would be noted as well.
5 secondary outcomes
Assessment of Pain from surgery to discharge tested at intervals using an 11 point linear numerical rating scale utilised for assessment of pain.
Time frame: 5 days
The total patient controlled analgesia (PCA) morphine consumption
Time frame: 5 days
Assessing the side effects of the anaesthetic technique specifically looking at PDPH throughout the recovery process in hospital, using the PONV
Time frame: 5 days
Assessing the side effects of the anaesthetic technique specifically looking at PDPH throughout the recovery process in hospital, using the VAS
Time frame: 5 days
Assessment of Patient Satisfaction using the Patient Anaesthesia Satisfaction Scale (PASS)
Time frame: 5 days
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 17 Mar 2020.
- Derived from this study: PubMed 33009185Bhatia K, Columb M, Wadsworth R, Macnab W, Jepegnanam C, Campbell T, Van Dellen D. Effect of rectus sheath block vs. spinal anaesthesia on time-to-readiness for hospital discharge after trans-peritoneal hand-assisted laparoscopic live donor nephrectomy: A randomised trial. Eur J Anaesthesiol. 2021 Apr 1;38(4):374-382. doi: 10.1097/EJA.0000000000001337.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine and Diamorphine, Remifentanil, Propofol and Cistracurium and Bupivacaine and Rectus Sheath injection in people with Surgery, run by Manchester University NHS Foundation Trust 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 2 inclusion and 8 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 17 Mar 2020. 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?
Assessment of readiness for discharge from hospital to determine Length of stay, after renal surgery, using a blinded Nurse assessment of patient. (time frame: 5 days). 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 NCT02700217, 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 17 Mar 2020.