Continuous Thoracic Epidural Versus Erector Spinae Plane Block for Postoperative Analgesia in Donar Hepatectomies.

November 2, 2019 updated by: Dr Muhammad Zubair, Shifa Clinical Research Center

"Continuous Thoracic Epidural Analgesia Versus Continuous Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Adult Living Donar Open Hepatectomies."

Introduction Adult living related donor hepatectomy is associated with pain due to the sub-costal j-shaped incision, rib retraction using Thompson retractor, and diaphragm irritation1. The incidence of severe pain after donor hepatectomy is 11 to 37%2. Therefore adequate analgesia is important for optimum perioperative safety profiles and speedy recovery. Poor pain management is associated with risk of atelectasis, respiratory failure, and delayed discharge from the hospital.

so this study is comparison of two technique (Thoracic epidural analgesia vs Erector spinae plane block) to relieve pain.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Thoracic epidural analgesia (TEA) is commonly used for pain management in donor hepatectomies. TEA reduces activation of the sympathetic outflow, surgical stress response, and pain-associated tachycardia and hypertension which can cause perioperative myocardial ischemia. TEA decreases stress-induced gastrointestinal disruption, immunosuppression, and decreases postoperative opioid requirement. TEA promotes expiratory intercostal and abdominal muscle tone and facilitates diaphragmatic excursion thus reduce the risks of atelectasis, pneumonia, and respiratory failure. However, TEA has its own drawbacks, e.g. hypotension caused by the inhibition of the sympathetic outflow, which can be associated with the administration of large amounts of crystalloids and colloids. Other complications may include failure to produce analgesia in 20% of patients3, intravascular cannulation leading to local anesthetic toxicity, unintentional dural punctures, paraesthesia, post-operative coagulopathies, epidural abscess, and epidural hematomas resulting in paraplegia1, 3. Considering these merits and demerits, TEA is the widely accepted choice for postoperative analgesia in living related donor hepatectomies1, 3,4, 5.

Erector spinae plane block (ESPB) is a novel ultrasound-guided regional anesthesia technique described in 2016 6 for the management of thoracic and abdominal pain. Ultrasound guidance is used to inject a local anesthetic in the interfacial plane between the erector spinae muscle and the associated transverse process of the spine. The mechanism of action is by the spread of local anesthetic anteriorly to the dorsal and ventral rami of the thoracic and abdominal spinal nerves 7. The absence of blood vessels in this vicinity shows the usefulness of this technique in the patients, who are prone to coagulopathies making it safer with lesser expertise, and with less procedural complications 8. The ESPB is an avascular plane block therefore, it results in lower plasma volumes rise due to reduced uptake of the local anesthetic by plasma hence the duration of action of local anesthetic is long. An ESPB at T5 level is sufficient to have a unilateral multi-dermatomes sensory block ranging from T1 to L3 level10 when used as a continuous block. Various case reports demonstrate its efficacy in a wide spectrum of specialities like acute and chronic pain management, thoraco-abdominal surgeries, neuropathic and post-traumatic pain 4, 7, 8,9 , 10. A comparison of continuous epidural versus single shot intrathecal morphine was made and assessed the quality of analgesia by a visual analog scale (VAS) and the additional IV analgesic requirements were 56% in cases of epidural 11 used for sample size calculation.

However, no randomized control study has been performed to compare the efficacy of a continuous ESPB with that of a continuous TEA for living related donor hepatectomies. Thus the aim of this study is to compare the postoperative analgesic efficacy and adverse effects of continuous ESPB to that of a continuous TEA in patients undergoing adult living donor hepatectomies. Investigators have hypothesized that continuous ESPB would provide better postoperative analgesia with fewer adverse effects. The primary outcome is post-operative pain scores using the visual analog scale (V.A.S) for pain at rest and at maximal inspiration during the post-operative period at PACU, 1, 6, 12, 24 and 48 hours. The secondary outcomes include lung incentive spirometry volumes, the dosage of adjunct nalbuphine used, hypotension, tachycardia, post-operative coagulopathy, early mobilization and discharge from surgical I.C.U (S.I.C.U).

Methodology After approval from the institutional and ethical review board and written informed consent, patients were randomized into either the TEA group or the ESPB group using the sealed enveloped method.

Study design The study will be a single-blinded, prospective, comparative, randomized control trial. The participants will be assigned to one of two groups; Group A will include patients receiving continuous TEA, whilst Group B will include patients receiving continuous ESPB. Both groups will receive their respective intervention after induction with standard general anesthesia.

Blinding is done at the level of assessor. The primary assessor will be blind with the type of technique applied and fill the Proforma according to standard routine with the same drug infusion.

Study population The study will include all adult patients undergoing elective living related donor hepatectomies for liver transplant surgery.

Study setting Study will be conducted in the liver transplant operating rooms of Shifa International Hospital.

Study duration The study duration will be of up to 12 months from the date of approval of the study from the hospital's institutional and ethical review board.

Randomization Randomization will be done by the simple random sampling technique using the sealed envelope method.

Sample Size Sample size was calculated by the WHO sample size calculator and using the following parameters; Level of significance - 5% Power of the test - 80% Proportion of patients requiring opioid in epidural group - 0.56 (ref no.13) Anticipated proportion of patients requiring opioid in ESP group - 0.25 Sample size - 30 patients in each group

Induction of General Anaesthesia In the operating room, the patient will be positioned on the operating table; the standard monitors: non-invasive blood pressure, ECG, pulse oximetry will be applied. A 20 gauge intravenous cannula will be secured on the dorsum of the hand and connected to a maintenance intravenous fluid therapy. The patient will be pre-oxygenated for 3 minutes with oxygen. The patient will be administered injection Ondansetron (0.1mg/kg) and injection Midazolam (0.02mg/kg) intravenous to start with. The patient will be induced with injection Buprenorphine (0.02mg/kg) and injection Propofol (2 mg/kg) mixed with Lidocaine (60 mg), and atracurium (0.5 mg/kg), after which an endotracheal tube will be inserted and mechanical ventilation will be initiated. A radial arterial line and a central venous line will be inserted. Both TEA and ESPB catheters will be placed after induction of general anesthesia for surgery by experienced practitioners in the left lateral decubitus position.

Data Collection Data for the study will be collected by a standardized performa which will record all the required variables of the study. Confidentiality of patient's data will be maintained.

Data Analysis The data will be analyzed by using the IBM SPSS software, version 25.0, for Windows.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
      • Islamabad, Pakistan, 44000
        • Recruiting
        • Hospital
        • Contact:
        • Principal Investigator:
          • Dr Muhammad Zubair, MBBS,FCPS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 - 45 years of age
  • A.S.A scores I - II Exclusion Criteria
  • Neurological impairment
  • Allergy, hypersensitivity or any other contraindications to local anesthetic
  • Anatomical variation for block landmarks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Continuous Thoracic Epidural
Continuous Thoracic Epidural Analgesia for Postoperative Analgesia in Patients Undergoing Adult Living Donar Open Hepatectomies
Procedure: Continuous Erector Spinae Plane Block
  1. Continuous Thoracic Epidural Thoracic Epidural Analgesia
  2. Continuous Erector Spinae Plane Block
Experimental: Continuous Erector Spinae Plane Block
Continuous Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Adult Living Donar Open Hepatectomies
Procedure: Continuous Erector Spinae Plane Block
  1. Continuous Thoracic Epidural Thoracic Epidural Analgesia
  2. Continuous Erector Spinae Plane Block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative pain scores
Time Frame: 6 hour
Post-operative pain scores using the visual analog scale (V.A.S) 0-10 for pain at rest and at maximal inspiration during the post-operative period at PACU. 0 means no pain and 10 means unbearable pain. Higher scores would be worse outcome. primary outcome post-operative pain scores measured at 6 hours.
6 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The dosage of adjunct nalbuphine used (mg)
Time Frame: 6 hour
The dosage of adjunct nalbuphine in milligrams (mg) required by the patient at 6 hours post-operatively.
6 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shifa Clinical Research Center

Collaborators

Shifa International Hospital

Investigators

  • Principal Investigator: Dr Muhammad Zubair, Shifa International Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2019

Primary Completion (Anticipated)

March 1, 2020

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

October 22, 2019

First Submitted That Met QC Criteria

November 2, 2019

First Posted (Actual)

November 5, 2019

Study Record Updates

Last Update Posted (Actual)

November 5, 2019

Last Update Submitted That Met QC Criteria

November 2, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB Ref #165-665-2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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