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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-16

Study Completion Date

2019-03-05

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

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Detailed Description

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Conditions

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Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Spinal Anaesthesia

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)

Group Type EXPERIMENTAL

Bupivacaine and Diamorphine

Intervention Type PROCEDURE

Remifentanil, Propofol and Cistracurium

Intervention Type PROCEDURE

Rectus Sheath Injection

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)

Group Type ACTIVE_COMPARATOR

Remifentanil, Propofol and Cistracurium

Intervention Type PROCEDURE

Bupivacaine and Rectus Sheath injection

Intervention Type PROCEDURE

Interventions

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Bupivacaine and Diamorphine

Intervention Type PROCEDURE

Remifentanil, Propofol and Cistracurium

Intervention Type PROCEDURE

Bupivacaine and Rectus Sheath injection

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No