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Completed

NCT Number: NCT02622893

Surgical Approach Affect on Post-operative Analgesic Requirement Following Laparoscopic Nephrectomy

Background: We performed this prospective clinical study to compare the post-operative recovery profile of our patients after transperitoneal and retroperitoneal laparoscopic nephrectomy techniques. Our primary aim was to compare post-operative epidural analgesic consumption of transperitoneal (Group T) and retroperitoneal (Group R) laparoscopic nephrectomy patients within the first 24 hours.

Methods: Forty-four patients scheduled for elective transperitoneal or retroperitoneal laparoscopic nephrectomies were enrolled. All patients in both groups received epidural catheter, 2.5ml test dose of lidocaine 2% and general anesthesia induction. At the end of the surgery, patients were given 1g IV paracetamol and 10ml 0.25% bupivacaine through epidural catheters and extubated. In the post-operative care unit, patients started to receive a continuous infusion of 0,1% bupivacaine and 1µg/ml fentanyl 5ml/h with patient-controlled boluses of an additional 4ml by a patient controlled epidural analgesia (PCEA) device. They were prescribed IV tramadol 1mg/kg as a rescue analgesic (Visual analog scale (VAS)≥4). Total analgesic consumptions from PCEA devices, VAS scores at rest and during mobilization, heart rates (HRs), systolic (SBPs)/diastolic blood pressures (DBPs) at extubation (0th min-basal) and at post-operative 30th min, 2nd, 6th, 12th, 18th and 24th hours as well as number of patients who require rescue analgesic were recorded. Nausea, vomiting, time to first mobilization, return of bowel sounds and hospital stay were also documented.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Istanbul University, Department of Anesthesiology

Istanbul, 34093, Turkey (Türkiye)

About this study

Background: We performed this prospective clinical study to compare the post-operative recovery profile of our patients after transperitoneal and retroperitoneal laparoscopic nephrectomy techniques. Our primary aim was to compare post-operative epidural analgesic consumption of transperitoneal (Group T) and retroperitoneal (Group R) laparoscopic nephrectomy patients within the first 24 hours.

Methods: Forty-four patients scheduled for elective transperitoneal or retroperitoneal laparoscopic nephrectomies were enrolled. All patients in both groups received epidural catheter, 2.5ml test dose of lidocaine 2% and general anesthesia induction. At the end of the surgery, patients were given 1g IV paracetamol and 10ml 0.25% bupivacaine through epidural catheters and extubated. In the post-operative care unit, patients started to receive a continuous infusion of 0,1% bupivacaine and 1µg/ml fentanyl 5ml/h with patient-controlled boluses of an additional 4ml by a patient controlled epidural analgesia (PCEA) device. They were prescribed IV tramadol 1mg/kg as a rescue analgesic (Visual analog scale (VAS)≥4). Total analgesic consumptions from PCEA devices, VAS scores at rest and during mobilization, heart rates (HRs), systolic (SBPs)/diastolic blood pressures (DBPs) at extubation (0th min-basal) and at post-operative 30th min, 2nd, 6th, 12th, 18th and 24th hours as well as number of patients who require rescue analgesic were recorded. Nausea, vomiting, time to first mobilization, return of bowel sounds and hospital stay were also documented. 0th and 30th min follow-ups were recorded in PACU and patients were passed on to ward nurses. Researchers who follow the patients at PACU and on the ward were all blinded to the surgical techniques.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • American Society of Anesthesiologists (ASA) physical status I-II
  • Scheduled for elective transperitoneal or retroperitoneal laparoscopic nephrectomy

Exclusion criteria

  • Serious heart or respiratory failure
  • Difficulty understanding the instructions for using the anesthetic infusion pump and/or pain scales
  • Contraindications to regional anesthesia (e.g., allergy to a local anesthetics, local infection, increased intracranial pressure and coagulopathy)
  • Significant neurologic disorders of the lower extremity
  • Psychiatric or cognitive disorders
  • History of substance abuse
  • Chronic opioid use
  • Patients having open nephrectomy

Treatment and study plan

Transperitoneal laparoscopic nephrectomy

Drug

After the surgery: 10 ml 0.25% bupivacaine through epidural catheters before extubation and continuous infusion of 0,1% bupivacaine and 1 µg/ml fentanyl 5 ml/h with patient-controlled boluses of an additional 4 ml, with a lockout time of 20 min and 4-h limit of 30 ml by a patient controlled epidural analgesia (PCEA) device

Other names: Patient controlled epidural analgesia (PCEA)

Retroperitoneal laparoscopic nephrectomy

Drug

After the surgery: 10 ml 0.25% bupivacaine through epidural catheters before extubation and continuous infusion of 0,1% bupivacaine and 1 µg/ml fentanyl 5 ml/h with patient-controlled boluses of an additional 4 ml, with a lockout time of 20 min and 4-h limit of 30 ml by a patient controlled epidural analgesia (PCEA) device

Other names: Patient controlled epidural analgesia (PCEA)

Primary outcomes

  1. Total epidural analgesic consumption

    Time frame: up to 24 hours

    Total epidural analgesic (bupivacaine and fentanyl) consumption from patient controlled epidural analgesia (PCEA) devices

Secondary outcomes

  1. Visual analog scale (VAS) scores

    Time frame: up to 24 hours

    Visual analog scale (VAS) scores at rest and during mobilization

  2. Number of patients who require rescue analgesic

    Time frame: up to 24 hours

    Number of patients who require IV tramadol (1 mg/kg) as a rescue analgesic besides PCEA use

  3. Hemodynamic parameters

    Time frame: up to 24 hours

    Postoperative heart rates (HRs), systolic (SBPs)/diastolic blood pressures (DBPs)

Other outcomes

  1. Complications

    Time frame: up to 24 hours

    Nausea, vomiting

  2. Time to first mobilization

    Time frame: up to 24 hours

    Time to first mobilization

  3. Return of bowel sounds/oral intake

    Time frame: through study completion, an average of 1 week

    Post-operative oral intake starts just after the return of bowel sounds (almost at the same time), will be assessed as hours (time to return of bowel sounds)

  4. Hospital stay

    Time frame: through study completion, an average of 1 week

    Hospitalisation

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

Can Surgical Approach Affect Post-operative Analgesic Requirements Following Laparoscopic Nephrectomy: Transperitoneal Versus Retroperitoneal? A Prospective Clinical Study

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 7, 2015
Registry last updated
Feb 17, 2016

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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