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
About this trial
This is an interventional treatment trial for Pain, Postoperative
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
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
NCT ID
NCT02622893
First Posted
November 26, 2015
Last Updated
February 14, 2016
Sponsor
Istanbul University
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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