Abdominal SurgeriesNCT02660632
Epidural Block vs. Rectus Sheath Block on Postoperative Pulmonary Function
A study testing Thoracic epidural analgesia (TEA) and Rectus sheath catheter block in people with Abdominal Surgeries, run by Mansoura University at 1 site in Egypt.
Trial summary
Pulmonary complications are among the most important postoperative complications after midline incisions, for which different analgesic modalities have been tried. Epidural analgesia is the recommended technique to relieve pain after major abdominal surgery owing to the proved superior analgesia, reduction of opioid… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Abdominal Surgeries
- What is being tested?
- Thoracic epidural analgesia (TEA) and Rectus sheath catheter block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2017to May 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists physical class I to III.
- Patients scheduled for elective midline laparotomy.
Who cannot join
- Morbid obese patients.
- Severe or uncompensated cardiovascular disease.
- Significant renal disease.
- Significant hepatic disease.
- Pregnancy.
- Lactating.
Show all 16Show fewer
- Allergy to the study medications.
- Psychological disorder.
- Neurological disorder.
- Communication barrier.
- Mental disorders.
- Epilepsy.
- FEV1 or FEV1/FVC ratio less than 50%, dyspnea with a New York Heart Association class IV.
- Drug or alcohol abuse.
- Contraindications to epidural anaesthesia.
- Opioid analgesic medication within 24 h before the operation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Thoracic Epidural Analgesia vs Rectus Sheath Catheters on Postoperative Pulmonary Function After Midline Laparotomy: A Prospective Randomized Controlled Study
Pulmonary complications are among the most important postoperative complications after midline incisions, for which different analgesic modalities have been tried.
Epidural analgesia is the recommended technique to relieve pain after major abdominal surgery owing to the proved superior analgesia, reduction of opioid related side effects as nausea, vomiting, pruritis and sedation, earlier recovery of bowel function and earlier ability for postoperative mobility However, it is not without complications.
Rectus sheath block provides several advantages over epidural anesthesia. It lessens the potential risks associated with neuraxial techniques, so it may represent a novel alternative approach for somatic analgesia after major abdominal surgeries. Although patients with rectus sheath block may experience some visceral pain, it is usually minimal by 24 hours after surgery.
Read the detailed description
The aim of this study is to compare the effects of thoracic epidural analgesia and rectus sheath blockade on postoperative pulmonary functions, pain scores, duration of analgesia, sedation scores, patients' satisfaction and adverse effects.
FEV1, FEV1/FVC ratio will be measured by a bed side spirometer.
- Induction of anesthesia: propofol 1.5-2.5 mg kg-1.
- Muscle Relaxants: rocuronium 0.6 mg kg-1 for induction.
- Maintenance: Sevoflurane 0.7-1.5 MAC vaporized in air-oxygen (40% inspired fraction).
Radial artery catheterization: under complete aseptic conditions 20G cannula will be inserted into the radial artery of non-dominant hand after performing modified Allen's test and local infiltration of 0.5ml xylocaine 2% .
Thoracic epidural catheter will be inserted before induction of general anaesthesia under aseptic insertion conditions and using loss of resistance to air technique with the patient in the sitting position at T9- T11 interspaces.
The Rectus sheath catheters will be inserted bilaterally using ultrasound (SonoSite M-Turbo®, Sonosite , USA) guidance as described by Webster after induction of general anaesthesia.
- Conditions
- Abdominal Surgeries
- Being tested
- Thoracic epidural analgesia (TEA), Rectus sheath catheter block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic epidural analgesia (TEA)Other
Epidural catheter will be inserted at T9-T11. Then, epidural analgesia will be activated with administering bolus of 10 mls 0.25% bupivacaine in conjunction with100 mcg fentanyl to establish a block. This will be followed by an infusion of 0.125% bupivacaine in conjunction with 2 mcg/ ml fentanyl at a rate of 10 mls /hour and then titrated to effect for up to 48 hour postoperative
Rectus sheath catheter blockOther
Following insertion of bilateral rectus sheath catheters, 20 ml of 0.25% bupivacaine will be injected through each one. Then continuous infusion pumps will be connected to the catheters and set to deliver boluses of 20 mL of 0.25% bupivacaine, with a 4-hour lockout for up to 48 h postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Thoracic epidural analgesia (TEA) | Placebo comparator | Patients who will be subjected for midline laparotomy, will receive epidural analgesia through an inserted thoracic epidural catheter before induction of general anesthesia Receives: Other: Thoracic epidural analgesia (TEA) |
| Rectus sheath catheter block | Active comparator | After insertion of bilateral rectus sheath catheters, 20 ml of 0.25% bupivacaine will be injected on each side, then continuous infusion pumps will be connected to the catheters and set to deliver boluses of 20 mL of 0.25% bupivacaine, with a 4-hour lockout for up to 48 h postoperatively. Receives: Other: Rectus sheath catheter block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in forced expiratory volume in 1 second (FEV1)
Measured: Before and for 72 hours after surgery
Changes in ratio between forced expiratory volume in 1 s and forced vital capacity (FEV1/FVC)
Measured: Before and for 72 hours after surgery
Secondary outcomes (11)
Changes in arterial blood gases
Measured: Before and for 72 hours after surgery
Visual analog pain scores
Postoperative pain will be assessed on rest and with cough and during movements for both of visceral and parietal pain
Measured: for 48 hours after surgery
Sedation score
Sedation scores using a sedation scale (awake and alert= 0; quietly awake= 1; asleep but easily roused= 2; deep sleep= 3.
Measured: for 48 hours after surgery
Postoperative nausea and vomiting
The degree of nausea and vomiting. Nausea will be measured using a numerical rating system (none= 0; mild= 1; moderate= 2; severe= 3). The number of vomiting episodes and the number of anti-emetics received
Measured: for 48 hours after surgery
Return of bowel function
The times to first flatus, defecation, intake of clear liquid and solid food tolerance
Measured: for 72 hours after surgery
Time to hospital discharge
from the end of anesthesia
Measured: for 15 days after surgery
Cumulative tramadol use
Measured: For 48 hours after surgery
Overall patient's satisfaction
Patient overall satisfaction will be assessed before hospital discharge using the visual analog score
Measured: For 48 hours after surgery
Intraoperative use of ephedrine
Measured: For 5 hours after induction of anesthesia
Postoperative cardio-respiratory complications
Measured: For 7 days after surgery
Postoperative wound infection
Measured: For 21 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (estimated)
- Study startJan 2017
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal SurgeriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samah Elkenany, MD, Principal investigator, Lecturer of Anesthesia and Surgical Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02660632
- Sponsor's protocol ID
- R ∕ 15.12.48
- Status last verified
- Jun 2018
- First submitted
- 16 Jan 2016
- Last updated
- 8 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Thoracic Epidural Analgesia vs Rectus Sheath Catheters on Postoperative Pulmonary Function After Midline Laparotomy: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02660632
- Acronym / sponsor ID
- R ∕ 15.12.48
- Conditions
- Abdominal Surgeries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 21 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pulmonary complications are among the most important postoperative complications after midline incisions, for which different analgesic modalities have been tried.
Epidural analgesia is the recommended technique to relieve pain after major abdominal surgery owing to the proved superior analgesia, reduction of opioid related side effects as nausea, vomiting, pruritis and sedation, earlier recovery of bowel function and earlier ability for postoperative mobility However, it is not without complications.
Rectus sheath block provides several advantages over epidural anesthesia. It lessens the potential risks associated with neuraxial techniques, so it may represent a novel alternative approach for somatic analgesia after major abdominal surgeries. Although patients with rectus sheath block may experience some visceral pain, it is usually minimal by 24 hours after surgery.
Detailed description
The aim of this study is to compare the effects of thoracic epidural analgesia and rectus sheath blockade on postoperative pulmonary functions, pain scores, duration of analgesia, sedation scores, patients' satisfaction and adverse effects.
FEV1, FEV1/FVC ratio will be measured by a bed side spirometer.
- Induction of anesthesia: propofol 1.5-2.5 mg kg-1.
- Muscle Relaxants: rocuronium 0.6 mg kg-1 for induction.
- Maintenance: Sevoflurane 0.7-1.5 MAC vaporized in air-oxygen (40% inspired fraction).
Radial artery catheterization: under complete aseptic conditions 20G cannula will be inserted into the radial artery of non-dominant hand after performing modified Allen's test and local infiltration of 0.5ml xylocaine 2% .
Thoracic epidural catheter will be inserted before induction of general anaesthesia under aseptic insertion conditions and using loss of resistance to air technique with the patient in the sitting position at T9- T11 interspaces.
The Rectus sheath catheters will be inserted bilaterally using ultrasound (SonoSite M-Turbo®, Sonosite , USA) guidance as described by Webster after induction of general anaesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracic epidural analgesia (TEA) | Placebo comparator | Other: Thoracic epidural analgesia (TEA)Patients who will be subjected for midline laparotomy, will receive epidural analgesia through an inserted thoracic epidural catheter before induction of general anesthesia |
| Rectus sheath catheter block | Active comparator | Other: Rectus sheath catheter blockAfter insertion of bilateral rectus sheath catheters, 20 ml of 0.25% bupivacaine will be injected on each side, then continuous infusion pumps will be connected to the catheters and set to deliver boluses of 20 mL of 0.25% bupivacaine, with a 4-hour lockout for up to 48 h postoperatively. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists physical class I to III.
- Patients scheduled for elective midline laparotomy.
Key exclusion criteria (16 listed)
- Morbid obese patients.
- Severe or uncompensated cardiovascular disease.
- Significant renal disease.
- Significant hepatic disease.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracic epidural analgesia (TEA)Epidural catheter will be inserted at T9-T11. Then, epidural analgesia will be activated with administering bolus of 10 mls 0.25% bupivacaine in conjunction with100 mcg fentanyl to establish a block. This will be followed by an infusion of 0.125% bupivacaine in conjunction with 2 mcg/ ml fentanyl at a rate of 10 mls /hour and then titrated to effect for up to 48 hour postoperative | Other | Thoracic epidural analgesia (TEA) |
| Rectus sheath catheter blockFollowing insertion of bilateral rectus sheath catheters, 20 ml of 0.25% bupivacaine will be injected through each one. Then continuous infusion pumps will be connected to the catheters and set to deliver boluses of 20 mL of 0.25% bupivacaine, with a 4-hour lockout for up to 48 h postoperatively. | Other | Rectus sheath catheter block |
Primary outcome
Changes in forced expiratory volume in 1 second (FEV1)
Time frame: Before and for 72 hours after surgery
Changes in ratio between forced expiratory volume in 1 s and forced vital capacity (FEV1/FVC)
Time frame: Before and for 72 hours after surgery
11 secondary outcomes
Changes in arterial blood gases
Time frame: Before and for 72 hours after surgery
Visual analog pain scores
Time frame: for 48 hours after surgery
Sedation score
Time frame: for 48 hours after surgery
Postoperative nausea and vomiting
Time frame: for 48 hours after surgery
Return of bowel function
Time frame: for 72 hours after surgery
Time to hospital discharge
Time frame: for 15 days after surgery
Cumulative tramadol use
Time frame: For 48 hours after surgery
Overall patient's satisfaction
Time frame: For 48 hours after surgery
Intraoperative use of ephedrine
Time frame: For 5 hours after induction of anesthesia
Postoperative cardio-respiratory complications
Time frame: For 7 days after surgery
Postoperative wound infection
Time frame: For 21 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samah Elkenany, MD principal investigator
Lecturer of Anesthesia and Surgical Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic epidural analgesia (TEA) and Rectus sheath catheter block in people with Abdominal Surgeries, run by Mansoura 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 2 inclusion and 16 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 8 Jun 2018. 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. Some participants in this study may receive a placebo. 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?
Changes in forced expiratory volume in 1 second (FEV1) (time frame: Before and for 72 hours after surgery). The study lists 2 primary outcomes in all. 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 8 Jun 2018.