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

I

Istanbul University

Status and phase

Completed
Phase 4

Conditions

Pain, Postoperative

Treatments

Drug: Transperitoneal laparoscopic nephrectomy
Drug: Retroperitoneal laparoscopic nephrectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT02622893
2009/1501

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

40 participants in 2 patient groups

Transperitoneal laparoscopic nephrectomy
Active Comparator group
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.
Treatment:
Drug: Transperitoneal laparoscopic nephrectomy
Retroperitoneal laparoscopic nephrectomy
Active Comparator group
Description:
Patients in this group underwent retroperitoneal laparoscopic nephrectomy in lateral decubitis position after receiving epidural catheter in the sitting position before the surgery.
Treatment:
Drug: Retroperitoneal laparoscopic nephrectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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