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

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

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Transperitoneal laparoscopic nephrectomy; Drug: Retroperitoneal laparoscopic nephrectomy

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34093
    • Istanbul University, Department of Anesthesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Transperitoneal laparoscopic nephrectomy; 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.	Drug: Transperitoneal laparoscopic nephrectomy; 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)
Active Comparator: Retroperitoneal laparoscopic nephrectomy; Patients in this group underwent retroperitoneal laparoscopic nephrectomy in lateral decubitis position after receiving epidural catheter in the sitting position before the surgery.	Drug: Retroperitoneal laparoscopic nephrectomy; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total epidural analgesic consumption	Total epidural analgesic (bupivacaine and fentanyl) consumption from patient controlled epidural analgesia (PCEA) devices	up to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analog scale (VAS) scores	Visual analog scale (VAS) scores at rest and during mobilization	up to 24 hours
Number of patients who require rescue analgesic	Number of patients who require IV tramadol (1 mg/kg) as a rescue analgesic besides PCEA use	up to 24 hours
Hemodynamic parameters	Postoperative heart rates (HRs), systolic (SBPs)/diastolic blood pressures (DBPs)	up to 24 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Nausea, vomiting	up to 24 hours
Time to first mobilization	Time to first mobilization	up to 24 hours
Return of bowel sounds/oral intake	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)	through study completion, an average of 1 week
Hospital stay	Hospitalisation	through study completion, an average of 1 week

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Principal Investigator: Meltem Savran Karadeniz, MD, Istanbul University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: November 26, 2015
• First Submitted That Met QC Criteria: December 2, 2015
• First Posted (Estimate): December 7, 2015

Study Record Updates

• Last Update Posted (Estimate): February 17, 2016
• Last Update Submitted That Met QC Criteria: February 14, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 2009/1501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No