Does Adding Spinal Anaesthesia to a General Anaesthetic Technique Influence Readiness for Discharge in Patients Having Hand Assisted Laparoscopic Live Donor Nephrectomy

Study Overview
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Brief Summary
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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
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Surgery

Intervention / Treatment
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* Procedure: Bupivacaine and Diamorphine
* Procedure: Remifentanil, Propofol and Cistracurium
* Procedure: Bupivacaine and Rectus Sheath injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA 1-2 status Patients aged between 18-65 years Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spinal Anaesthesia<br>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) | Procedure: Bupivacaine and Diamorphine<br> <br> Procedure: Remifentanil, Propofol and Cistracurium<br> <br> |
| Active Comparator: Rectus Sheath Injection<br>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) | Procedure: Remifentanil, Propofol and Cistracurium<br> <br> Procedure: Bupivacaine and Rectus Sheath injection<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 days | 
| The total patient controlled analgesia (PCA) morphine consumption |  | 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). | 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'. | 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. | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Donor Nephrectomy