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

March 16, 2020 updated by: Manchester University NHS Foundation Trust

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Manchester, United Kingdom, M13 9WL
        • Central Manchester University Hospitals NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
Procedure: Bupivacaine and Diamorphine
Procedure: Remifentanil, Propofol and Cistracurium
Active Comparator: 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)
Procedure: Remifentanil, Propofol and Cistracurium
Procedure: Bupivacaine and Rectus Sheath injection

What is the study measuring?

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.
Time Frame: 5 days

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.
Time Frame: 5 days

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
Time Frame: 5 days
5 days
Assessing the side effects of the anaesthetic technique specifically looking at PDPH throughout the recovery process in hospital, using the PONV
Time Frame: 5 days
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
Time Frame: 5 days
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)
Time Frame: 5 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Manchester University NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2016

Primary Completion (Actual)

March 5, 2019

Study Completion (Actual)

March 5, 2019

Study Registration Dates

First Submitted

February 9, 2016

First Submitted That Met QC Criteria

March 1, 2016

First Posted (Estimate)

March 7, 2016

Study Record Updates

Last Update Posted (Actual)

March 17, 2020

Last Update Submitted That Met QC Criteria

March 16, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R04134

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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