Epidural Analgesia and Postoperative Respiratory Functions (EPAPRES)

NCT ID: NCT03643757

Last Updated: 2018-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-01
• Study Completion Date: 2018-03-01

Brief Summary

Patients operated with posterolateral thoracotomy were enrolled. Post-operative analgesia was provided either by TEA with 0.1% bupivacaine or pethidine based intravenous analgesia (IVA) in our sample population. Perception of pain was quantified by Visual Analogue Scale (VAS) at rest and during coughing. Arterial blood samples were collected at 1st, 24th and 72nd hours of post-operative period. Pre-operative and post-operative 72nd-hour spirometric measurements were recorded

Detailed Description

lung cancer patients (between ages 18 to 75 and American Society of Anesthesiologists -ASA- Class I to III), undergoing an elective thoracic surgical procedure with posterolateral thoracotomy, were enrolled. The study was approved by the local ethical committee in Yedikule Chest Diseases and Thoracic Surgery Ed. and Research Hospital and therefore had been performed in accordance with global ethical standards. Written informed consent was received from all participants.

Individuals beyond defined age limits, patients who have psychiatric problems, auditory deficit, drug abuse, severe cardiovascular system disorders or severe respiratory depression depicted as having less than 50% of the predicted value of forced expiratory volume were excluded. Patients refusing to give consent and to whom inserting an epidural catheter is contraindicated were not involved either. Surgical procedures were performed by the same team. In the operating room, if serratus anterior muscle could not be spared or chest wall resection was performed, these patients were also excluded even though they had met other qualifications. Finally, patients who could not be extubated before transfer were not involved.

Regarding pre-operative evaluation, age, gender, weight, height, smoking status (package/years) and ASA score of patients were recorded.

For assessing the impact of method of analgesia on target parameters, patients were allocated to TEA and intravenous analgesia (IVA) groups. Randomisation was performed by closed envelope method.

2.2 Features of anesthetic technique and intraoperative analgesia Before the initiation of procedure, in TEA group epidural catheter was inserted by loss of resistance method at the level of T3-T7 with the help of a 18 G Thuohy needle (Pajunk, Geisingen, Germany) while patient was on sitting position. A test dose of 2 ml, 2% Lidocaine HCL was administered through the catheter. Once, efficacy was confirmed, 10 ml bolus dose of 0.1% Bupivacaine was injected. Analgesia maintanence was provided by infusion of 0.1% Bupivacaine (0.1 ml/kg/hour) both intra- and postoperatively for 24 hours.

Anesthesia was induced with midazolam (0.04 mg/kg), propofol (2 mg/kg) and fentanyl (1mcg/kg) in both groups and the neuromuscular blockage was provided with cisatracurium besilate (0,2 mg/kg). Then, insertion of a double-lumen tracheal tube was performed. After standard patient positioning, localization of the tube was checked with a fiberoptic bronchoscope. Pressure controlled ventilation was used (Primius, Drager, Luebeck, Germany) and invasive arterial pressure, electrocardiography, arterial blood gas analysis, end-tidal carbon dioxide concentration, central venous pressure and urine output were closely monitored in the operating room. Hypothermia was avoided with the help of a warming system and body temperature was kept over 36°C. In TEA group, absolute intraoperative analgesia was warranted with 0,5-2 MAC sevoflurane. In IVA group, remifentanyl infusion (0.1-0.2 mcg/kg/min) was additionally used for this purpose. If arterial pressure exceeds a value of 20% or more of baseline recordings, 1 mcg/kg fentanyl was administered. Every one hour, an additional dose (0.25 mg/kg) of cisatracurium besilate was administered to ensure complete myorelaxation.

The intercostal blockage was applied by the surgical team to the entire population before closing the wound by injecting 4 ml of 0.25% bupivacaine to the region of incision and two intercostal regions above and below the incision site. Once closure was started, morphine sulphate (0,1 mg/kg), tramadol (100 mg), paracetamol (100 mg) and tenoxicam (20 mg) was given intravenously. Anterior 28 Ch and posterior 32 Ch drainage tubes were inserted to the patients to whom lobectomy or bilobectomy was performed. For pneumectomy, only posterior 32 Ch tube was placed. After reversal of neuromuscular blocking agents, patients with adequate spontaneous ventilation and verbal response were transferred to the critical care unit.

Regarding to peri-operative data, procedure time, type of the operation (lobectomy or pneumectomy), duration of tube drainage and presence of operation related complications were recorded.

Visual Analogue Score (VAS) was used to estimate the severity of pain. A score of 0 cm represented "no pain at all" and 10 cm did "intractable pain" so.

Conditions

Respiration Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Thoracic Epidural Analgesia

Population to whom thoracic epidural analgesia with bupivacaine as a component of multimodal analgesia was administered.

Group Type: ACTIVE_COMPARATOR

Thoracic epidural analgesia

Intervention Type: PROCEDURE

Before the initiation of the procedure, in the intervention group epidural catheter was inserted by loss of resistance method at the level of T3-T7 with the help of an 18 G Thuohy needle (Pajunk, Geisingen, Germany) while the patient was on sitting position. A test dose of 2 ml, 2% Lidocaine HCL was administered through the catheter. Once, efficacy was confirmed, 10 ml bolus dose of 0.1% Bupivacaine was injected. Analgesia maintenance was provided by infusion of 0.1% Bupivacaine (0.1 ml/kg/hour) both intra- and postoperatively for 24 hours.

Bupivacaine

Intervention Type: DRUG

In addition to multimodal analgesia protocol, epidural bupivacaine was administered in TEA arm and pain relief was achieved by intravenous pethidine infusion in IVA arm.

Intravenous analgesia

Population to whom combined intravenous analgesia was administered.

Group Type: ACTIVE_COMPARATOR

Thoracic epidural analgesia

Intervention Type: PROCEDURE

Before the initiation of the procedure, in the intervention group epidural catheter was inserted by loss of resistance method at the level of T3-T7 with the help of an 18 G Thuohy needle (Pajunk, Geisingen, Germany) while the patient was on sitting position. A test dose of 2 ml, 2% Lidocaine HCL was administered through the catheter. Once, efficacy was confirmed, 10 ml bolus dose of 0.1% Bupivacaine was injected. Analgesia maintenance was provided by infusion of 0.1% Bupivacaine (0.1 ml/kg/hour) both intra- and postoperatively for 24 hours.

Interventions

Thoracic epidural analgesia

Before the initiation of the procedure, in the intervention group epidural catheter was inserted by loss of resistance method at the level of T3-T7 with the help of an 18 G Thuohy needle (Pajunk, Geisingen, Germany) while the patient was on sitting position. A test dose of 2 ml, 2% Lidocaine HCL was administered through the catheter. Once, efficacy was confirmed, 10 ml bolus dose of 0.1% Bupivacaine was injected. Analgesia maintenance was provided by infusion of 0.1% Bupivacaine (0.1 ml/kg/hour) both intra- and postoperatively for 24 hours.

Intervention Type: PROCEDURE

Bupivacaine

In addition to multimodal analgesia protocol, epidural bupivacaine was administered in TEA arm and pain relief was achieved by intravenous pethidine infusion in IVA arm.

Intervention Type: DRUG

Other Intervention Names

Posterolateral thorachotomy; Intercostal blockade; Pethidine intravenous infusion

Eligibility Criteria

Inclusion Criteria

• American Society of Anesthesiologists -ASA- Class I to III)
• Scheduled for an elective thoracic surgical procedure with posterolateral thoracotomy

Exclusion Criteria

• Individuals beyond defined age limits
• Having psychiatric problems
• Having an auditory deficit
• Active drug abuse
• Severe cardiovascular system disorders
• Severe respiratory depression depicted as having less than 50% of the predicted value of forced expiratory volume
• Refusing to give consent
• Contraindication to insertion of an epidural catheter.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yedikule Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Derya Ozden Omaygenc

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Erturk E, Aydogdu Kaya F, Kutanis D, Besir A, Akdogan A, Geze S, Tugcugil E. The effectiveness of preemptive thoracic epidural analgesia in thoracic surgery. Biomed Res Int. 2014;2014:673682. doi: 10.1155/2014/673682. Epub 2014 Mar 13.

Reference Type: RESULT

PMID: 24745020 (View on PubMed)

Helander EM, Webb MP, Bias M, Whang EE, Kaye AD, Urman RD. Use of Regional Anesthesia Techniques: Analysis of Institutional Enhanced Recovery After Surgery Protocols for Colorectal Surgery. J Laparoendosc Adv Surg Tech A. 2017 Sep;27(9):898-902. doi: 10.1089/lap.2017.0339. Epub 2017 Jul 25.

Reference Type: RESULT

PMID: 28742434 (View on PubMed)

Rawal N. Epidural technique for postoperative pain: gold standard no more? Reg Anesth Pain Med. 2012 May-Jun;37(3):310-7. doi: 10.1097/AAP.0b013e31825735c6.

Reference Type: RESULT

PMID: 22531384 (View on PubMed)

Other Identifiers

2866

Identifier Type: -

Identifier Source: org_study_id