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

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Transperitoneal laparoscopic nephrectomy
Retroperitoneal laparoscopic nephrectomy
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Istanbul University, Department of Anesthesiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Transperitoneal laparoscopic nephrectomy

Retroperitoneal laparoscopic nephrectomy

Arm Description

Patients in this group underwent transperitoneal laparoscopic nephrectomy in 45-60º modified flank position after receiving epidural catheter in the sitting position before the surgery.

Patients in this group underwent retroperitoneal laparoscopic nephrectomy in lateral decubitis position after receiving epidural catheter in the sitting position before the surgery.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Visual analog scale (VAS) scores
Visual analog scale (VAS) scores at rest and during mobilization
Number of patients who require rescue analgesic
Number of patients who require IV tramadol (1 mg/kg) as a rescue analgesic besides PCEA use
Hemodynamic parameters
Postoperative heart rates (HRs), systolic (SBPs)/diastolic blood pressures (DBPs)

Full Information

First Posted
November 26, 2015
Last Updated
February 14, 2016
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT02622893
Brief Title
Surgical Approach Affect on Post-operative Analgesic Requirement Following Laparoscopic Nephrectomy
Official Title
Can Surgical Approach Affect Post-operative Analgesic Requirements Following Laparoscopic Nephrectomy: Transperitoneal Versus Retroperitoneal? A Prospective Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transperitoneal laparoscopic nephrectomy
Arm Type
Active Comparator
Arm Description
Patients in this group underwent transperitoneal laparoscopic nephrectomy in 45-60º modified flank position after receiving epidural catheter in the sitting position before the surgery.
Arm Title
Retroperitoneal laparoscopic nephrectomy
Arm Type
Active Comparator
Arm Description
Patients in this group underwent retroperitoneal laparoscopic nephrectomy in lateral decubitis position after receiving epidural catheter in the sitting position before the surgery.
Intervention Type
Drug
Intervention Name(s)
Transperitoneal laparoscopic nephrectomy
Other Intervention Name(s)
Patient controlled epidural analgesia (PCEA)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Retroperitoneal laparoscopic nephrectomy
Other Intervention Name(s)
Patient controlled epidural analgesia (PCEA)
Intervention Description
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
Primary Outcome Measure Information:
Title
Total epidural analgesic consumption
Description
Total epidural analgesic (bupivacaine and fentanyl) consumption from patient controlled epidural analgesia (PCEA) devices
Time Frame
up to 24 hours
Secondary Outcome Measure Information:
Title
Visual analog scale (VAS) scores
Description
Visual analog scale (VAS) scores at rest and during mobilization
Time Frame
up to 24 hours
Title
Number of patients who require rescue analgesic
Description
Number of patients who require IV tramadol (1 mg/kg) as a rescue analgesic besides PCEA use
Time Frame
up to 24 hours
Title
Hemodynamic parameters
Description
Postoperative heart rates (HRs), systolic (SBPs)/diastolic blood pressures (DBPs)
Time Frame
up to 24 hours
Other Pre-specified Outcome Measures:
Title
Complications
Description
Nausea, vomiting
Time Frame
up to 24 hours
Title
Time to first mobilization
Description
Time to first mobilization
Time Frame
up to 24 hours
Title
Return of bowel sounds/oral intake
Description
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)
Time Frame
through study completion, an average of 1 week
Title
Hospital stay
Description
Hospitalisation
Time Frame
through study completion, an average of 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meltem Savran Karadeniz, MD
Organizational Affiliation
Istanbul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University, Department of Anesthesiology
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28678012
Citation
Savran-Karadeniz M, Kisa I, Salviz EA, Ozkan-Seyhan T, Tefik T, Sanli O, Tugrul KM. Can surgical approach affect postoperative analgesic requirements following laparoscopic nephrectomy: Transperitoneal versus retroperitoneal? A prospective clinical study. Arch Esp Urol. 2017 Jul;70(6):603-611.
Results Reference
derived

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

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