Surgical Approach Affect on Post-operative Analgesic Requirement Following Laparoscopic Nephrectomy
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Transperitoneal laparoscopic nephrectomy; Retroperitoneal laparoscopic nephrectomy
Intervention type(s): Drug; Drug
Intervention description(s): 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; 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 intervention name(s): Patient controlled epidural analgesia (PCEA); Patient controlled epidural analgesia (PCEA)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment