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

NHS Foundation Trust

Status: Completed

Conditions: Surgery

Treatments: Procedure: Remifentanil, Propofol and Cistracurium; Procedure: Bupivacaine and Diamorphine; Procedure: Bupivacaine and Rectus Sheath injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02700217

R04134

Details and patient eligibility

About

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

Enrollment: 101 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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101 participants in 2 patient groups

Spinal Anaesthesia

Experimental group

Description:

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)

Treatment:

Procedure: Remifentanil, Propofol and Cistracurium

Procedure: Bupivacaine and Diamorphine

Rectus Sheath Injection

Active Comparator group

Description:

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)

Treatment:

Procedure: Bupivacaine and Rectus Sheath injection

Procedure: Remifentanil, Propofol and Cistracurium