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

NCT02622893 | Completed Phase 4

• 1 other identifier: 2009/1501
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Total epidural analgesic consumption

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

  up to 24 hours

Secondary Outcomes (3)

• Visual analog scale (VAS) scores

  up to 24 hours

• Number of patients who require rescue analgesic

  up to 24 hours

• Hemodynamic parameters

  up to 24 hours

Other Outcomes (4)

• Complications

  up to 24 hours

• Time to first mobilization

  up to 24 hours

• Return of bowel sounds/oral intake

  through study completion, an average of 1 week

Study Arms (2)

Transperitoneal laparoscopic nephrectomy

ACTIVE COMPARATOR

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

Retroperitoneal laparoscopic nephrectomy

ACTIVE COMPARATOR

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

Interventions

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

Also known as: Patient controlled epidural analgesia (PCEA)

Transperitoneal laparoscopic nephrectomy

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

Also known as: Patient controlled epidural analgesia (PCEA)

Retroperitoneal laparoscopic nephrectomy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University, Department of Anesthesiology

Istanbul, Istanbul, 34093, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 28678012 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Meltem Savran Karadeniz, MD

  Istanbul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Anesthesiologist

Study Record Dates

• First Submitted: November 26, 2015
• First Posted: December 7, 2015
• Study Start: January 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: February 17, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)