AnalgesiaPhase 2/3NCT04813016
Intraperitoneal Tramadol Versus Dexmedetomedine for Analgesia After Abdominal Laparoscopic Cancer Surgeries
A Phase 2/3 study testing Tramal 1, Tramal 2 and Dexmedetomidine 1 in people with Analgesia, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
Multiple modalities for postoperative analgesia after laparoscopic procedures has been used, of them intraperitoneal route (IP) was used to decrease the analgesic requirements. Both early and late bupivacaine and tramadol versus bupivacaine and dexmedetomedine will be tried to choose which is having a better analgesic… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Analgesia
- What is being tested?
- Tramal 1, Tramal 2 and Dexmedetomidine 1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2021to 1 May 2022
- Phase
- Phase 2/3
- 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
- ASA II or III.
- Age 18 to 65 years.
- Elective surgeries
Who cannot join
- Patients with severe hepatic (more than child c), renal (known CKD)and cardiac (known IHD) troubles.
- Patients with extensive intraperitoneal adhesions.
- Patients with a history of drug or analgesic abuse.
- Known drug allergy or indigestion.
- Intraoperative lavage of more than 500ml.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Intraperitoneal Administration of Either Bupivacaine and Tramadol Versus Bupivacaine and Dexmedetomedine for Analgesia After Abdominal Laparoscopic Cancer Surgeries. A Prospective Randomized Pilot Study
Multiple modalities for postoperative analgesia after laparoscopic procedures has been used, of them intraperitoneal route (IP) was used to decrease the analgesic requirements. Both early and late bupivacaine and tramadol versus bupivacaine and dexmedetomedine will be tried to choose which is having a better analgesic profile.
Read the detailed description
Recently laparoscopic procedures have become popular and familiar to both surgeons and anesthetists. They have many advantages such as rapid postoperative recovery, low postoperative complication rates, early mobilization, and early home discharge; consequently reduce hospital stay and costs. Although previous studies have been shown that laparoscopy is associated with less pain than laparotomy, it is not totally pain free. Some laparoscopic procedures for abdominal cancer surgeries has shown that there may be more intense pain and greater analgesic requirements in the immediate postoperative period than after open laparotomy.
Thoroughly understanding the difference of pain generators in laparotomy than in laparoscopy gave some ideas helping in the control of each of them. While laparotomy results mainly in parietal pain, visceral pain remains predominantly in patients after laparoscopic surgeries resulting from the stretching of intra-abdominal cavity, peritoneal inflammation and phrenic nerve irritation caused by residual carbon dioxide in the peritoneal cavity resulting in postoperative abdominal and shoulder pain after laparoscopy. Hence, Intraperitoneal (IP) administration of some drugs can be effective for pain relief after laparoscopic surgery. The results have been variable as the published studies are heterogeneous and often lack appropriate controls. For that, no definitive conclusion can yet be made regarding its value and effectiveness.
The α2-adrenergic agonist provides excellent sedation, anxiolysis, analgesia and sympatholysis. Of them, dexmedetomidine has become one of the frequently used drugs in anaesthesia aiming to its hemodynamic, sedative, anxiolytic, analgesic, neuroprotective and anaesthetic sparing effect. In addition, the high selectivity of dexmedetomidine to α2- receptors favored its widespread use in regional anaesthesia practice and local nerve blocks techniques.
As noradrenergic neurons descending through the dorso-lateral funiculus from the brainstem to the dorsal horn significantly contribute in the modulation of pain by controlling impulse transmission (descending inhibitory pathway). Adrenergic agonists, such as dexmedetomedine, possess significant antinociceptive activity by a central action on the brainstem and a spinal action on the substantia gelatinosa of the dorsal horn.
Tramadol is a synthetic opioid pain medication used to treat moderate to moderately severe pain. It exerts its analgesic effects through a variety of different targets on the noradrenergic, serotoninergic and opioid receptors systems. It also exists as a racemic mixture, the positive enantiomer inhibits serotonin reuptake while the negative enantiomer inhibits noradrenaline re-uptake, by binding to and blocking the transporters. Finally, tramadol has also been shown to act as a serotonin releasing agent. Both enantiomers of tramadol are agonists of the μ-opioid receptor and its M1 metabolite, O-demethylate, which is also a μ-opioid receptor agonist but is 6 times more potent than tramadol itself. All these effects work synergistically to induce analgesia.
The aim of this study is to examine and compare the effect of both early and late intraperitoneal bupivacaine/tramadol and bupivacaine/dexmedetomedine analgesia on the effectiveness of postoperative analgesia and the requirement of postoperative rescue analgesics after laparoscopic surgery for abdominal cancer surgeries.
- Conditions
- Analgesia
- Being tested
- Tramal 1, Tramal 2, Dexmedetomidine 1, dexmedetomidine 2
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tramal 1Drug
Also called Early tramal
Early intraperitoneal injection of tramal and bupivacaine
Tramal 2Drug
Also called Late tramal
Late intraperitoneal injection of tramal and bupivacaine
Dexmedetomidine 1Drug
Also called Early Dexmedetomidine
Early intraperitoneal injection of dexmedetomidine and bupivacaine
dexmedetomidine 2Drug
Also called Late Dexmedetomidine
Late intraperitoneal injection of dexmedetomedine and bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Early tramal/bupivacaine | Active comparator | patients received 50 ml of isotonic aqueous solution (PH 7.45) of tramadol 150mg mixed with bupivacaine 0.25% immediately before creation of a pneumoperitoneum and placement of the first two trocars before starting the surgery. Receives: Drug: Tramal 2; Drug: Dexmedetomidine 1; Drug: dexmedetomidine 2 |
| Late tramal/bupivacaine | Active comparator | patients received 50ml of isotonic aqueous solution (PH 7.45) of tramadol 150mg mixed with bupivacaine 0.25% after completion of surgery and before trocars removal. Receives: Drug: Tramal 1; Drug: Dexmedetomidine 1; Drug: dexmedetomidine 2 |
| Early dexmedetomedine/bupivacaine | Active comparator | patients received 50ml of isotonic aqueous solution (PH 7.45) of dexmedetomedine(1µ/kg) mixed with bupivacaine 0.25% before creation of a pneumoperitoneum and placement of the first two trocars before the start of surgery. Receives: Drug: Tramal 1; Drug: Tramal 2; Drug: dexmedetomidine 2 |
| Late dexmedetomedine/bupivacaine | Active comparator | patients received 50ml of isotonic aqueous solution (PH 7.45) of dexmedetomedine(1µ/kg) mixed with bupivacaine 0.25% after completion of surgery and before trocars removal. Receives: Drug: Tramal 1; Drug: Tramal 2; Drug: Dexmedetomidine 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of pain
measurement of VAS
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start1 Mar 2021
- Primary completion30 Apr 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Hanafy Shaker, National Cancer Institute, Egypt
- Investigators
- Ehab H Gendy, MD, Principal investigator, Assistant Professor of Anesthesia, intensive care and pain releif
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04813016
- Sponsor's protocol ID
- intraperitoneal analgesia
- Status last verified
- Jun 2022
- First submitted
- 20 Mar 2021
- Last updated
- 2 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After manuscript approval and acceptance by a journal
Publications
Shaker EH, Soliman MS, Hanafy A, Elsabeeny WY. Comparative Study Between Early versus Late Intraperitoneal Administration of Either Bupivacaine/Tramadol or Bupivacaine/Dexmedetomidine for Perioperative Analgesia in Abdominal Laparoscopic Cancer Surgeries: A Prospective Randomized Study. J Pain Res. 2022 Oct 18;15:3233-3243. doi: 10.2147/JPR.S376681. eCollection 2022.
PubMed 36281310
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Intraperitoneal Administration of Either Bupivacaine and Tramadol Versus Bupivacaine and Dexmedetomedine for Analgesia After Abdominal Laparoscopic Cancer Surgeries. A Prospective Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT04813016
- Acronym / sponsor ID
- intraperitoneal analgesia
- Conditions
- Analgesia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 24 Mar 2021 (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.
Multiple modalities for postoperative analgesia after laparoscopic procedures has been used, of them intraperitoneal route (IP) was used to decrease the analgesic requirements. Both early and late bupivacaine and tramadol versus bupivacaine and dexmedetomedine will be tried to choose which is having a better analgesic profile.
Detailed description
Recently laparoscopic procedures have become popular and familiar to both surgeons and anesthetists. They have many advantages such as rapid postoperative recovery, low postoperative complication rates, early mobilization, and early home discharge; consequently reduce hospital stay and costs. Although previous studies have been shown that laparoscopy is associated with less pain than laparotomy, it is not totally pain free. Some laparoscopic procedures for abdominal cancer surgeries has shown that there may be more intense pain and greater analgesic requirements in the immediate postoperative period than after open laparotomy.
Thoroughly understanding the difference of pain generators in laparotomy than in laparoscopy gave some ideas helping in the control of each of them. While laparotomy results mainly in parietal pain, visceral pain remains predominantly in patients after laparoscopic surgeries resulting from the stretching of intra-abdominal cavity, peritoneal inflammation and phrenic nerve irritation caused by residual carbon dioxide in the peritoneal cavity resulting in postoperative abdominal and shoulder pain after laparoscopy. Hence, Intraperitoneal (IP) administration of some drugs can be effective for pain relief after laparoscopic surgery. The results have been variable as the published studies are heterogeneous and often lack appropriate controls. For that, no definitive conclusion can yet be made regarding its value and effectiveness.
The α2-adrenergic agonist provides excellent sedation, anxiolysis, analgesia and sympatholysis. Of them, dexmedetomidine has become one of the frequently used drugs in anaesthesia aiming to its hemodynamic, sedative, anxiolytic, analgesic, neuroprotective and anaesthetic sparing effect. In addition, the high selectivity of dexmedetomidine to α2- receptors favored its widespread use in regional anaesthesia practice and local nerve blocks techniques.
As noradrenergic neurons descending through the dorso-lateral funiculus from the brainstem to the dorsal horn significantly contribute in the modulation of pain by controlling impulse transmission (descending inhibitory pathway). Adrenergic agonists, such as dexmedetomedine, possess significant antinociceptive activity by a central action on the brainstem and a spinal action on the substantia gelatinosa of the dorsal horn.
Tramadol is a synthetic opioid pain medication used to treat moderate to moderately severe pain. It exerts its analgesic effects through a variety of different targets on the noradrenergic, serotoninergic and opioid receptors systems. It also exists as a racemic mixture, the positive enantiomer inhibits serotonin reuptake while the negative enantiomer inhibits noradrenaline re-uptake, by binding to and blocking the transporters. Finally, tramadol has also been shown to act as a serotonin releasing agent. Both enantiomers of tramadol are agonists of the μ-opioid receptor and its M1 metabolite, O-demethylate, which is also a μ-opioid receptor agonist but is 6 times more potent than tramadol itself. All these effects work synergistically to induce analgesia.
The aim of this study is to examine and compare the effect of both early and late intraperitoneal bupivacaine/tramadol and bupivacaine/dexmedetomedine analgesia on the effectiveness of postoperative analgesia and the requirement of postoperative rescue analgesics after laparoscopic surgery for abdominal cancer surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Early tramal/bupivacaine | Active comparator | Drug: Tramal 2, Drug: Dexmedetomidine 1, Drug: dexmedetomidine 2patients received 50 ml of isotonic aqueous solution (PH 7.45) of tramadol 150mg mixed with bupivacaine 0.25% immediately before creation of a pneumoperitoneum and placement of the first two trocars before starting the surgery. |
| Late tramal/bupivacaine | Active comparator | Drug: Tramal 1, Drug: Dexmedetomidine 1, Drug: dexmedetomidine 2patients received 50ml of isotonic aqueous solution (PH 7.45) of tramadol 150mg mixed with bupivacaine 0.25% after completion of surgery and before trocars removal. |
| Early dexmedetomedine/bupivacaine | Active comparator | Drug: Tramal 1, Drug: Tramal 2, Drug: dexmedetomidine 2patients received 50ml of isotonic aqueous solution (PH 7.45) of dexmedetomedine(1µ/kg) mixed with bupivacaine 0.25% before creation of a pneumoperitoneum and placement of the first two trocars before the start of surgery. |
| Late dexmedetomedine/bupivacaine | Active comparator | Drug: Tramal 1, Drug: Tramal 2, Drug: Dexmedetomidine 1patients received 50ml of isotonic aqueous solution (PH 7.45) of dexmedetomedine(1µ/kg) mixed with bupivacaine 0.25% after completion of surgery and before trocars removal. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA II or III.
- Age 18 to 65 years.
- Elective surgeries
Key exclusion criteria (5 listed)
- Patients with severe hepatic (more than child c), renal (known CKD)and cardiac (known IHD) troubles.
- Patients with extensive intraperitoneal adhesions.
- Patients with a history of drug or analgesic abuse.
- Known drug allergy or indigestion.
- Intraoperative lavage of more than 500ml.
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 |
|---|---|---|
| Tramal 1Also: Early tramalEarly intraperitoneal injection of tramal and bupivacaine | Drug | Early dexmedetomedine/bupivacaine, Late dexmedetomedine/bupivacaine, Late tramal/bupivacaine |
| Tramal 2Also: Late tramalLate intraperitoneal injection of tramal and bupivacaine | Drug | Early dexmedetomedine/bupivacaine, Early tramal/bupivacaine, Late dexmedetomedine/bupivacaine |
| Dexmedetomidine 1Also: Early DexmedetomidineEarly intraperitoneal injection of dexmedetomidine and bupivacaine | Drug | Early tramal/bupivacaine, Late dexmedetomedine/bupivacaine, Late tramal/bupivacaine |
| dexmedetomidine 2Also: Late DexmedetomidineLate intraperitoneal injection of dexmedetomedine and bupivacaine | Drug | Early dexmedetomedine/bupivacaine, Early tramal/bupivacaine, Late tramal/bupivacaine |
Primary outcome
The degree of pain
Time frame: 24 hours
measurement of VAS
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 2 Jun 2022.
- Derived from this study: PubMed 36281310Shaker EH, Soliman MS, Hanafy A, Elsabeeny WY. Comparative Study Between Early versus Late Intraperitoneal Administration of Either Bupivacaine/Tramadol or Bupivacaine/Dexmedetomidine for Perioperative Analgesia in Abdominal Laparoscopic Cancer Surgeries: A Prospective Randomized Study. J Pain Res. 2022 Oct 18;15:3233-3243. doi: 10.2147/JPR.S376681. eCollection 2022.
- Intraperitoneal dexmedetomidine as an adjuvant to bupivacaine for postoperative painLink provided by the sponsor.
- Individual participant dataSharing planned: No. After manuscript approval and acceptance by a journal
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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.
Ehab H Gendy, MD principal investigator
Assistant Professor of Anesthesia, intensive care and pain releif
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tramal 1, Tramal 2 and Dexmedetomidine 1 in people with Analgesia, run by National Cancer Institute, Egypt 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 5 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 2 Jun 2022. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The degree of pain (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04813016, which also lists 1 linked publication.
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 2 Jun 2022.