Lower Abdominal Oncologic SurgeryNCT03276325
Epidural Steroids With Intrathecal Nalbuphine for Lower Abdominal Oncologic Surgery
A study testing Dexamethasone-nalbuphine in people with Lower Abdominal Oncologic Surgery, run by Mansoura University at 1 site in Egypt.
Trial summary
Intraoperative pain, nausea, vomiting, hypotension, bradycardia are known side effects during lower abdominal surgery under spinal anesthesia, Time to 2 segment regression of sensory block and duration of effective analgesia prolonged with intrathecal (IT) 0.4 mg nalbuphine \& IT 0.8 mg nalbuphine, but the incidence… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lower Abdominal Oncologic Surgery
- What is being tested?
- Dexamethasone-nalbuphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2017to 7 Jan 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists physical class I or II.
- Undergoing laparotomy
- Undergoing oophorectomy
- Undergoing hysterectomy
- Undergoing rectal mass excision
Who cannot join
- Patient refusal.
- Hypersensitivity to amide local anesthetics.
- General contraindications to spinal anesthesia.
- Cardiac diseases.
- Hepatic failure.
- Renal failure.
- Respiratory failure.
- Communication barriers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidural Steroids Combined With Intrathecal Nalbuphine: Analgesic and Side Effects Concept in Lower Abdominal Surgical Oncology Procedures
Intraoperative pain, nausea, vomiting, hypotension, bradycardia are known side effects during lower abdominal surgery under spinal anesthesia, Time to 2 segment regression of sensory block and duration of effective analgesia prolonged with intrathecal (IT) 0.4 mg nalbuphine \& IT 0.8 mg nalbuphine, but the incidence of side-effects was significantly higher with IT 0.8 mg nalbuphine compared with (IT) 0.4 mg nalbuphine.
Read the detailed description
So, the hypothesis of using IT nalbuphine mid away dose 0.6 mg between the best intraoperative analgesic effective dose 0.8 mg and the least side effect producing dose 0.4mg with the addition of epidural dexamethasone could augment the postoperative analgesia and reduce the unwanted side effects. Epidural dexamethasone in a full dose of 8 mg is probably more effective than lower doses to control moderate to severe post-operative pain. Dexamethasone 8mg dose is surgically safe neither produced delayed wound healing nor elevated blood glucose level.
- Conditions
- Lower Abdominal Oncologic Surgery
- Being tested
- Placebo-nalbuphine, Dexamethasone-nalbuphine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo-nalbuphineDrug
Epidural injection of normal saline followed with intrathecal injection of 0.6 mg nalbuphine in conjunction with 4 ml of hyperbaric bupivacaine 0.5%
Dexamethasone-nalbuphineDrug
Epidural injection of dexamethasone followed with intrathecal injection of 0.6 mg nalbuphine in conjunction with 4 ml of hyperbaric bupivacaine 0.5%
| Study group | Role | What they receive |
|---|---|---|
| Placebo-nalbuphine | Placebo comparator | Epidural injection of normal saline followed with intrathecal injection of 0.6 mg nalbuphine in conjunction with 4 ml of hyperbaric bupivacaine 0.5% Receives: Drug: Placebo-nalbuphine |
| Dexamethasone-nalbuphine | Active comparator | Epidural injection of dexamethasone followed with intrathecal injection of 0.6 mg nalbuphine in conjunction with 4 ml of hyperbaric bupivacaine 0.5% Receives: Drug: Dexamethasone-nalbuphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Pain visual analog score (0: no pain, 100: worst imaginable pain)
Measured: For 24 hours after surgery
Secondary outcomes (11)
Nausea and vomiting
(0: no nausea, 1: nausea, 2: mild vomiting, 3: moderate vomiting, 4: severe vomiting)
Measured: For 24 hours after surgery
Sensory recovery
Regression to S1 spinal segment as tested with cold sensation
Measured: For 5 hours after induction of anaesthesia
Motor recovery
The time until decreased a modified Bromage score of 0 (i.e. full leg movement)
Measured: For 5 hours after induction of anaesthesia
First analgesic request
Time to first request of rescue analgesic
Measured: For 12 hours after induction of anaesthesia
Intraoperative heart rate changes
Changes in heart rate during surgery
Measured: For 3 hours after induction of anaesthesia
Intraoperative mean arterial blood pressure changes
Changes in mean arterial blood pressure during surgery
Measured: For 3 hours after induction of anaesthesia
Postoperative heart rate changes
Changes in heart rate after surgery
Measured: For 24 hours after surgery
Postoperative mean arterial blood pressure changes
Changes in mean arterial blood pressure after surgery
Measured: For 24 hours after surgery
Cumulative use of antiemetic
Cumulative use of metoclopramide and ondansetron after surgery
Measured: for 24 hrs after surgery
Cumulative use of rescue intravenous ketorolac
Rescue use of ketorolac in case of severe pain conditions
Measured: for 24 hrs after surgery
Cumulative use of rescue intravenous nalbuphine
Rescue use of nalbuphine in case of severe pain conditions
Measured: For 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start15 Sep 2017
- Primary completion1 Jan 2018
- Study completion7 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Abdominal Oncologic SurgeryStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed A Ghanem, MD, Study chair, Assistant Professor of Anesthesia and Surgical Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03276325
- Sponsor's protocol ID
- R/17.04.127
- Status last verified
- Jan 2018
- First submitted
- 6 Sep 2017
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidural Steroids Combined With Intrathecal Nalbuphine: Analgesic and Side Effects Concept in Lower Abdominal Surgical Oncology Procedures
- ClinicalTrials.gov ID
- NCT03276325
- Acronym / sponsor ID
- R/17.04.127
- Conditions
- Lower Abdominal Oncologic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 7 Jan 2018 (actual)
- First posted
- 8 Sep 2017 (actual)
- 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.
Intraoperative pain, nausea, vomiting, hypotension, bradycardia are known side effects during lower abdominal surgery under spinal anesthesia, Time to 2 segment regression of sensory block and duration of effective analgesia prolonged with intrathecal (IT) 0.4 mg nalbuphine \& IT 0.8 mg nalbuphine, but the incidence of side-effects was significantly higher with IT 0.8 mg nalbuphine compared with (IT) 0.4 mg nalbuphine.
Detailed description
So, the hypothesis of using IT nalbuphine mid away dose 0.6 mg between the best intraoperative analgesic effective dose 0.8 mg and the least side effect producing dose 0.4mg with the addition of epidural dexamethasone could augment the postoperative analgesia and reduce the unwanted side effects. Epidural dexamethasone in a full dose of 8 mg is probably more effective than lower doses to control moderate to severe post-operative pain. Dexamethasone 8mg dose is surgically safe neither produced delayed wound healing nor elevated blood glucose level.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo-nalbuphine | Placebo comparator | Drug: Placebo-nalbuphineEpidural injection of normal saline followed with intrathecal injection of 0.6 mg nalbuphine in conjunction with 4 ml of hyperbaric bupivacaine 0.5% |
| Dexamethasone-nalbuphine | Active comparator | Drug: Dexamethasone-nalbuphineEpidural injection of dexamethasone followed with intrathecal injection of 0.6 mg nalbuphine in conjunction with 4 ml of hyperbaric bupivacaine 0.5% |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- American Society of Anesthesiologists physical class I or II.
- Undergoing laparotomy
- Undergoing oophorectomy
- Undergoing hysterectomy
- Undergoing rectal mass excision
Key exclusion criteria (8 listed)
- Patient refusal.
- Hypersensitivity to amide local anesthetics.
- General contraindications to spinal anesthesia.
- Cardiac diseases.
- Hepatic failure.
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 |
|---|---|---|
| Placebo-nalbuphineEpidural injection of normal saline followed with intrathecal injection of 0.6 mg nalbuphine in conjunction with 4 ml of hyperbaric bupivacaine 0.5% | Drug | Placebo-nalbuphine |
| Dexamethasone-nalbuphineEpidural injection of dexamethasone followed with intrathecal injection of 0.6 mg nalbuphine in conjunction with 4 ml of hyperbaric bupivacaine 0.5% | Drug | Dexamethasone-nalbuphine |
Primary outcome
Pain score
Time frame: For 24 hours after surgery
Pain visual analog score (0: no pain, 100: worst imaginable pain)
11 secondary outcomes
Nausea and vomiting
Time frame: For 24 hours after surgery
Sensory recovery
Time frame: For 5 hours after induction of anaesthesia
Motor recovery
Time frame: For 5 hours after induction of anaesthesia
First analgesic request
Time frame: For 12 hours after induction of anaesthesia
Intraoperative heart rate changes
Time frame: For 3 hours after induction of anaesthesia
Intraoperative mean arterial blood pressure changes
Time frame: For 3 hours after induction of anaesthesia
Postoperative heart rate changes
Time frame: For 24 hours after surgery
Postoperative mean arterial blood pressure changes
Time frame: For 24 hours after surgery
Cumulative use of antiemetic
Time frame: for 24 hrs after surgery
Cumulative use of rescue intravenous ketorolac
Time frame: for 24 hrs after surgery
Cumulative use of rescue intravenous nalbuphine
Time frame: For 24 hours 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 9 Jan 2018.
- Individual participant dataSharing planned: Undecided
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.
Mohamed A Ghanem, MD study chair
Assistant Professor 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 Dexamethasone-nalbuphine in people with Lower Abdominal Oncologic Surgery, 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 5 inclusion and 8 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 9 Jan 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?
Pain score (time frame: For 24 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 9 Jan 2018.