Does Adding Spinal Anaesthesia to a General Anaesthetic Technique Influence Readiness for Discharge in Patients Having Hand Assisted Laparoscopic Live Donor Nephrectomy
1 other identifier
interventional
101
1 country
1
Brief 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. 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable surgery
Started Mar 2016
Typical duration for not_applicable surgery
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2016
CompletedFirst Posted
Study publicly available on registry
March 7, 2016
CompletedStudy Start
First participant enrolled
March 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 5, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 5, 2019
CompletedMarch 17, 2020
March 1, 2020
3 years
February 9, 2016
March 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 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.
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
5 days
Assessing the side effects of the anaesthetic technique specifically looking at PDPH throughout the recovery process in hospital, using the VAS
5 days
Assessment of Patient Satisfaction using the Patient Anaesthesia Satisfaction Scale (PASS)
5 days
Study Arms (2)
Spinal Anaesthesia
EXPERIMENTAL2.5ml 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 COMPARATOR50ml 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)
Interventions
Eligibility Criteria
You may qualify if:
- ASA 1-2 status
- Patients aged between 18-65 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Central Manchester University Hospitals NHS Foundation Trust
Manchester, M13 9WL, United Kingdom
Related Publications (1)
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.
PMID: 33009185DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2016
First Posted
March 7, 2016
Study Start
March 16, 2016
Primary Completion
March 5, 2019
Study Completion
March 5, 2019
Last Updated
March 17, 2020
Record last verified: 2020-03