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Pain Relief in Upper Abdominal Cancer SurgeriesNCT04776109

Analgesic Efficacy of Erector Spinae Infusion Versus Thoracic Epidural for Patients With Upper Abdominal Cancer Surgeries

A study testing erector spinae block in people with Pain Relief in Upper Abdominal Cancer Surgeries, run by Assiut University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Epidural analgesia is considered by many to be the reference standard which has been shown to reduce the intraoperative surgical stress response. However, besides its excellent analgesic effect, there are some disadvantages associated with epidural analgesia. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
erector spinae block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
15 Feb 2021to 11 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients subjected to major upper abdominal cancer surgery.
  • The enrolled age will be from 18 years to 70 years
  • ASA I-II and NYHA I-II.

Who cannot join

  • ASA physical status >II, and NYHA >II
  • Patient refusal
  • body mass index >40 kg/m2
  • preoperative opioid consumption
  • a local infection at the incision site
  • a history of hematological disorders or coagulation abnormality
Show all 11Show fewer
  • previous abdominal surgeries, severe hepatic or renal impairment
  • Anomalies of vertebral column.
  • Pregnant women
  • Hypersensitivity to any of used drugs
  • chronic pain

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • South Egypt Cancer Institute

    Asyut, 71511

Other trials in Egypt

About this study

Official title: Analgesic Efficacy of Erector Spinae Infusion Versus Thoracic Epidural Infusion of Bupivacaine for Postoperative Pain in Patients Undergoing Upper Abdominal Cancer Surgeries

Epidural analgesia is considered by many to be the reference standard which has been shown to reduce the intraoperative surgical stress response.

However, besides its excellent analgesic effect, there are some disadvantages associated with epidural analgesia. This includes the risk of epidural hematoma/abscess ,failure rates hypotension, urinary retention. Also the need for preoperative placement in awake patients, who seem to dislike and sometimes even refuse. It is contra-indicated in the presence of coagulopathy or local sepsis.

Read more

ESPB is a faster procedure that carries a lower risk of hypotension, can be used in patients with coagulopathy, easy to perform, and requires less training.

So this study is to compare the postoperative analgesic effect of continous bupivacaine infusion via thoracic epidural versus erector spinae catheters following upper abdominal cancer surgery.

Read the detailed description

Surgical trauma activates numerous receptors leading to severe postoperative pain. Therefore, effective pain management is a priority of care and a patient right.

Postoperative pain may cause tachycardia, hypertension, increased cardiac work, nausea, vomiting, ileus. Also if it is inadequately managed may lead to detrimental Cardiovascular effects, pulmonary dysfunction, immune system, neuro-endocrine and metabolic effects, gastrointestinal, urinary dysfunction, coagulation system , cognitive dysfunction and also have psychological, economic and social adverse effects Good postoperative analgesia can prevent morbidity associated with abdominal surgeries by allowing pain-free, early ambulation and decreasing the risks of long hospital stay, thromboembolism, and other poor outcomes.

Adequate pain treatment is an important component of modern perioperative care and essential for a fast recovery. Choosing the optimal analgesic modality remains a topic of debate especially in major abdominal surgeries.

Epidural analgesia is considered by many to be the reference standard. It is used routinely in many thoracic surgery centers. Epidural blockade has been shown to reduce the intraoperative surgical stress response and has possible advantages for cardiovascular, respiratory, coagulation, gastrointestinal, metabolic and immune function However, besides its excellent analgesic effect, there are some disadvantages associated with epidural analgesia. This includes the risk of epidural hematoma/abscess (incidence 1:1,000-6,000 in surgical patients), failure rates of up to 30%, hypotension, urinary retention , in rare cases; paraplegia. Also the need for preoperative placement in awake patients, who seem to dislike and sometimes even refuse . It is contra-indicated in the presence of coagulopathy or local sepsis.

In the last decade, there has been a significant shift away from thoracic epidural analgesia (TEA) that has been long considered as the gold standard.

Various techniques have been tried to replicate the analgesic efficacy of TEA. They include transversus abdominis plane analgesia (TAP), rectus sheath analgesia (RS), wound infusion analgesia (WI) and transmuscular quadratus lumborum (TQL) analgesia.

However each of these techniques has specific limitations that prevent them from being the analgesic technique of choice for all open abdominal surgeries.

Epidural analgesia is commonly used in patients following abdominal surgeries except in cases with elevated intracranial tension, coagulopathy, patient refusal, and local sepsis.

Truncal blocks such as transversus abdominis plane (TAP) blocks have seen limited success due to shorter duration and suboptimal analgesia.

The ultrasound (US)-guided erector spinae plane block (ESPB) was initially described by Forero et al.It as a relatively new technique, originally described to manage thoracic pain when performed at the T5 vertebra level, but it has also been successfully used for abdominal analgesia when performed at T7 level.

ESPB gained wide attention as it is a faster procedure that carries a lower risk of hypotension, can be used in patients with coagulopathy, easy to perform, and requires less training.

ESPB provides extensive, potent unilateral analgesia, performed by local anesthetic injection in the plane between the erector spinae muscle and the TP. The local anesthetic diffuses into the paravertebral space through spaces between adjacent vertebrae and blocks both the dorsal and ventral rami of the thoracic spinal nerves.

Bilateral ESPB performed at low thoracic levels provides satisfactory analgesia for abdominal surgeries in case reports and series describing abdominal exploration, cesarean section, ventral hernia repair, and abdominoplasty. [21-23] As LA widely spreads cranially and caudally when ESPB is performed, we think that ESPB can effectively be used as an analgesic method for abdominal surgeries.

Aims of the study The objective of this study is to compare the postoperative analgesic effect of continous bupivacaine infusion via thoracic epidural versus erector spinae catheters following upper abdominal cancer surgery

Patients and Methods After obtaining institutional ethical committee approval and written informed consent from each patient, patients undergoing major upper abdominal cancer surgery who will be applicable to our study inclusion criteria ( at South Egypt Cancer Institute from December 2020 to December 2022) will be enrolled in this study.

patients will be randomized by the use of computer generated table of random numbers in a 1:1 ratio and conducted using a numbered, opaque and sealed envelope into two groups, First group (Group of continous thoracic epidural bupivacaine infusion [CEI]) Second group (Group of continous bilateral erector spinae bupivacaine infusions[CESI]) Group I : An epidural catheter will be inserted via a paramedian approach as close as possible to the surgical procedure via the inter-vertebral space (from T8 to T10) so that the affected dermatomes of the surgical wound would receive the benefits of bupivacaine (sunny-bupivacaine) infusion. Proper placement of the catheter will be verified through an aspiration test and a test dose (2 ml) of lidocaine 2% with adrenaline. At the end of surgery, a 0.2 ml/kg bolus of bupivacaine 0.25% will be administered through the catheter and then an infusion of bupivacaine 0.25% at a rate of 0.1 ml/kg/h will be administered immediately postoperative and continued for 48 hours.

Group II : Bilateral erector spinae catheters will be placed at T8 level. Surface anatomy or ultrasound (counting up from the 12th rib) will be used to identify the level of T8 after skin sterilization with the patient on the lateral position. Then a high frequency linear-array ultrasound transducer (Sono Site MW, Bothell, WA, USA) covered in a sterile sleeve will be placed in a longitudinal parasagittal orientation 3 cm lateral to the midline to identify the back muscles: the trapezius above, the rhomboid major in the middle, and the erector-spinae muscle on the bottom, and the transverse Processes with shimmering pleura in between. Next, 2-3 ml of 2% lidocaine will be infiltrated .

A 16-G, 8-cm Tuohy needle (Portex; Smiths Medical International Ltd, Kent, UK) will be then introduced medially in the plane of the ultrasound beam and directed towards the transverse process. Once the needle is underneath the anterior fascia of the erector spinae muscle, 10 ml of saline 0.9% will be injected. The injectate will be observed spreading underneath the ES muscle lifting the muscle of the transverse process. A catheter (Portex; Smiths Medical International Ltd) will be inserted into the newly formed space underneath the ES muscle and secured. The procedure will be repeated on the contralateral side. bupivacaine (20 ml of bupivacaine 0.25%) solution will be injected into each catheter over five minutes and then an infusion of bupivacaine 0.25% at a rate of 0.1 ml/kg/h will be administered immediately postoperative and continued for 48 hours on both sides.

Postoperatively, all patients will receive IV morphine (3 mg) when needed with VAS score < 3 for a period of 48 hours.

Procedures will be done under complete antiseptic technique. General anesthesia In the preoperative room, standard monitoring probes will be attached, IV 18 G cannula will be inserted and 1 L of normal saline will be infused. In the operative room, after pre-oxygenation for 3 minutes, anesthesia will be induced with intravenous (propofol 1.5 mg/kg) and fentanyl 2 μg/kg. Tracheal intubation will be performed after adequate neuromuscular blockade with rocuronium 0.6 mg/kg. Anesthesia will be maintained by isoflurane 1-1.5 MAC, rocuronium 0.3 mg/kg will given when indicated. Fentanyl 0.5 μg/kg will be given to maintain heart rate (HR) and blood pressure within 20% of the basal value. Patients will be mechanically ventilated to maintain end tidal (ETCO2) between 35-40 mmHg. The inspired oxygen fraction (FIO2) will be 0.5 using oxygen-and-air mixtures. At the end of surgery neuromuscular block will antagonized in all patients with sugammadex 1μg/kg and finally the patients will be extubated in the operative room. Hypotension will determined as a systolic blood pressure < 85 mmHg and will be managed with IV ephedrine 0.1 mg/kg. Bradycardia will be determined as heart rate slower than 50 beats/min and will be given atropine 0.01 mg/kg.

Being tested
erector spinae block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • erector spinae blockProcedure or surgery

    Also called thoracic epidural block

    Bilateral erector spinae catheters will be placed at T8 level. an ultrasound transducer will be placed in a longitudinal parasagittal orientation 3 cm lateral to the midline to identify the back muscles and the transverse Processes. Next, 2-3 ml of 2% lidocaine will be infiltrated .

    A 16-G, 8-cm Tuohy needle will be then introduced medially in the plane of the ultrasound beam and directed towards the transverse process. Once the needle is underneath the anterior fascia of the erector spinae muscle, 10 ml of saline 0.9% will be injected lifting the muscle of the transverse process. A catheter will be inserted into the newly formed space underneath the ES muscle and secured. The procedure will be repeated on the contralateral side. bupivacaine (20 ml of bupivacaine 0.25%) solution will be injected immediately into each catheter then infusion of bupivacaine 0.125% 0.1 ml/kg/h will be continued for 48 hours.

Study groups in NCT04776109
Study groupRoleWhat they receive
(Group of continous thoracic epidural bupivacaine infusion [CEI])Active comparatorGroup I : An epidural catheter will be inserted via a paramedian approach as close as possible to the surgical procedure via the inter-vertebral space (from T8 to T10) so that the affected dermatomes of the surgical wound would receive the benefits of bupivacaine (sunny-bupivacaine) infusion. Proper placement of the catheter will be verified through an aspiration test and a test dose (2 ml) of lidocaine 2% with adrenaline. At the end of surgery, a 0.2 ml/kg bolus of bupivacaine 0.25% will be administered through the catheter and then an infusion of bupivacaine 0.125% at a rate of 0.1 ml/kg/h will be administered immediately postoperative and continued for 48 hours.
Receives: Procedure: erector spinae block
(Group of continous bilateral erector spinae bupivacaine infusions[CESI])Active comparatorGroup II : Bilateral erector spinae catheters will be placed at T8 level. Surface anatomy or ultrasound (counting up from the 12th rib) will be used to identify the level of T8 after skin sterilization with the patient on the lateral position. Then a high frequency linear-array ultrasound transducer (Sono Site MW, Bothell, WA, USA) covered in a sterile sleeve will be placed in a longitudinal parasagittal orientation 3 cm lateral to the midline to identify the back muscles: the trapezius above, the rhomboid major in the middle, and the erector-spinae muscle on the bottom, and the transverse Processes with shimmering pleura in between. Next, 2-3 ml of 2% lidocaine will be infiltrated. A catheter will be inserted and secured. The procedure will be repeated on the contralateral side. 20 ml of bupivacaine 0.25% solution will be injected immediately into each catheter then infusion of bupivacaine 0.125% 0.1 ml/kg/h will be continued for 48 hours.
Receives: Procedure: erector spinae block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pain intensity measured by 11 points Visual Analogue Scale

    to assess pain intensity at rest and during pain-provoking movements (deep breathing, coughing, mobilization) measured by 11 points Visual Analogue Scale (VAS) score in which 0 indicates no pain and 10 indicates the severest pain

    Measured: immediately postoperative for 48 hours after surgery.

Secondary outcomes (2)
  1. Hemodynamic variable measured by blood pressure in mmHG

    Measured: immediately postoperative for 48 hours after surgery.

  2. Hemodynamic variable measured by heart rate in beats per minute

    Measured: immediately postoperative for 48 hours after surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2021
  2. Study start15 Feb 2021
  3. Primary completion15 Oct 2021
  4. Study completion11 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
First group (Group of continous thoracic epidural bupivacaine infusion \[CEI\]) Second group (Group of continous bilateral erector spinae bupivacaine infusions\[CESI\])
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04776109
Sponsor's protocol ID
521
Status last verified
Dec 2023
First submitted
18 Feb 2021
Last updated
18 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing erector spinae block in people with Pain Relief in Upper Abdominal Cancer Surgeries, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pain intensity measured by 11 points Visual Analogue Scale (time frame: immediately postoperative for 48 hours after surgery.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.

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