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Completed

NCT Number: NCT02700217

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

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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Key information

Conditions

Surgery

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Central Manchester University Hospitals NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine and Diamorphine

Procedure

Remifentanil, Propofol and Cistracurium

Procedure

Bupivacaine and Rectus Sheath injection

Procedure

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.

    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.

Secondary outcomes

  1. 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.

  2. The total patient controlled analgesia (PCA) morphine consumption

    Time frame: 5 days

  3. 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).

  4. 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. 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.

Sponsors and collaborators

Lead sponsor

Manchester University NHS Foundation Trust

Other Gov

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 7, 2016
Registry last updated
Mar 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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