Clinical trial NCT02700217: Does Adding Spinal Anaesthesia to a General Anaesthetic Technique Influence Readiness for Discharge in Patients Having Hand Assisted Laparoscopic Live Donor Nephrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Keywords: Donor Nephrectomy
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2016-03-07
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Assessment of readiness for discharge from hospital to determine Length of stay, after renal surgery, using a blinded Nurse assessment of patient.
timeFrame: 5 days
Secondary outcomes:
measure: Assessment of Pain from surgery to discharge tested at intervals using an 11 point linear numerical rating scale utilised for assessment of pain.
timeFrame: 5 days
measure: The total patient controlled analgesia (PCA) morphine consumption
timeFrame: 5 days
measure: Assessing the side effects of the anaesthetic technique specifically looking at PDPH throughout the recovery process in hospital, using the PONV
timeFrame: 5 days
measure: Assessing the side effects of the anaesthetic technique specifically looking at PDPH throughout the recovery process in hospital, using the VAS
timeFrame: 5 days
measure: Assessment of Patient Satisfaction using the Patient Anaesthesia Satisfaction Scale (PASS)
timeFrame: 5 days
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Central Manchester University Hospitals NHS Foundation Trust
Study officials:
References:
citation: 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.