Pain, AcuteNCT04037878
Tap Block vs Peritoneal Infiltration After Major Gynecological Surgeries
A study testing Transversus Abdominis Plane Block(TAP Block), Intra-peritoneal infiltration and PCIA Tramadol in people with Pain, Acute, run by Aga Khan University at 1 site in Pakistan.
Trial summary
It is a randomized controlled trial to determine the total tramadol consumption after major gynecological studies. Intervention groups include TAP block or local infiltration by the surgeon. These will be compared to a control group. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute
- What is being tested?
- Transversus Abdominis Plane Block(TAP Block), Intra-peritoneal infiltration and PCIA Tramadol
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Nov 2017to 23 Jun 2020
- 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 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Weight between 40 and 90kg
- ASA(American Society of Anesthesiologists) I to III
- Females scheduled for major gynecological surgeries(Abdominal hysterectomy, myomectomy, ovarian cystectomy, oophorectomy) through Pfannenstiel incision
Who cannot join
- Refusal to participate in the study,
- History of drug allergy to bupivacaine, tramadol or other narcotics, addiction/ tolerance to opioids,
- Having bleeding disorders,
- Abdominal skin infections or open wounds/ abdominal drains,
- Previous history of failed TAP block,
- On blood thinners or narcotic analgesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Opioid Consumption Following TAP Block Versus Intraperitoneal/Incisional Bupivicaine in Patients Undergoing Major Gynecologic Surgeries: A Randomized Controlled Trial
It is a randomized controlled trial to determine the total tramadol consumption after major gynecological studies. Intervention groups include TAP block or local infiltration by the surgeon. These will be compared to a control group. Total tramadol consumption will be calculated and therefore pain control will be assessed.
Read the detailed description
All patients will receive standardized general anesthetic with standard monitoring. Anesthesia will be induced with intravenous (IV) tramadol (1milligram/kg), propofol (2 mg/kg) and atracurium 0.5mg/kg. Anaesthesia will be maintained with oxygen/air (40:60) with one MAC(Minimum Alveolar Concentration) of isoflurane.
TAP block will be performed for Group T patients before surgical incision with the help of an ultrasound and will be performed by two of the anesthesiologists who are part of this study. The study drug for the TAP block will be two syringes of 20 ml containing bupivacaine 0.25% with no other additives. For the infiltration group I, a 50ml syringe will contain 25ml of 0.5% Bupivacaine and 25ml of 5mics/ml epinephrine. These solutions will be made there and then by the anesthesiologist and the drugs for these solutions will be provided by the clinical trial unit. Allocation to group T, I and C will be according to the randomization block explained earlier. For group T, the US-guided TAP block technique will be similar to the method described by Hebbard and colleagues; (21) an ultrasound linear probe will be positioned in the mid-axillary line in the axial plane half-way between the iliac crest and the costal margin. Transversus abdominal plain will be located under ultrasound guidance. One ml test injection of the study solution will be permitted to confirm needle location. A total of 20ml of study solution will be injected on each side after aspiration to avoid intravascular placement. Surgical incision will be given after 20 minutes of TAP. Additional doses of Tramadol 10mg IV stat will be given on need basis (Rise of heart rate and blood pressure more than 20 % of baseline).
Towards the end of surgery, 50 ml of solution prepared by the anesthesiologist will be used for Group I. 50ml of 0.25% Bupivicaine with epinephrine will be poured into a sterile galley pot, from which the surgeon will draw up the solution. The surgeon will be asked to spray 10ml of this solution on to the pouch of Douglas, 10ml in the peritoneum, 10ml in the rectus sheath and 20ml in the skin.
The amount of Bupivicaine used for group I and T is less than the maximum safe dose which is 2.5mg per kg. Minimal side effects are reported using an ultrasound guided TAP block technique(22). If an immediate side effect is noted while performing the technique, treatment will be administered and the patient will be withdrawn from the study.
The control group (C) will receive the standard anesthesia and analgesia as mentioned above without any nerve block technique.
Prophylactic antiemetics in the form of ondansetron 4mg IV stat block and IV paracetamol 15mg/kg will be administered 30 minutes before the end of surgery and diclofenac 100 mg suppository will be administered at the end of surgery.
Routine monitoring of intraoperative blood pressures, heart rates, (base line, induction, surgical incision and at 10 minutes interval) administered fluid and drugs, surgical time and estimated blood loss will be recorded on intraoperative chart.
After completion of the surgical procedure, patients will be transferred to the post anesthesia care unit (PACU). A standardized postoperative analgesic regimen, consisting of regular rectal diclofenac 100 mg every 12 hours and oral paracetamol 1000mg every 6 hrs combined with IV PCIA Tramadol (no baseline infusion, demand bolus dose 15 mg, lock out 8 min), will be commenced on admission to the PACU for all 3 groups. Total tramadol consumption and side effects will be calculated at end of 12 hours.
- Conditions
- Pain, Acute
- Being tested
- Transversus Abdominis Plane Block(TAP Block), Intra-peritoneal infiltration, PCIA Tramadol
- Keywords
- TAP block, Local infiltration, Tramadol, Gynecological surgery, Pain control
- Medical subject headings
- Acute Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus Abdominis Plane Block(TAP Block)Procedure or surgery
Under ultrasound guidance, a 22 gauge stimuplex needle will be used to approach the transversus abdominis plane and 20ml of 0.25% Bupivicaine will be infiltrated into the TAP space. This procedure will be performed on either sides once anesthesia is induced.
Intra-peritoneal infiltrationProcedure or surgery
Before skin closure, the surgeon will infiltrate the peritoneal cavity using a mixture of bupivicaine and epinephrine
PCIA TramadolDrug
All patients will be given patient controlled intravenous analgesia using Tramadol as the drug
| Study group | Role | What they receive |
|---|---|---|
| TAP block group | Experimental | Patients in this arm will be given Transversus Abdominal Plane(TAP) block after the induction of anesthesia. They will also be given post operative patient controlled intravenous analgesia(PCIA) using tramadol. Receives: Procedure: Transversus Abdominis Plane Block(TAP Block); Drug: PCIA Tramadol |
| Local infiltration | Experimental | Patients in this arm will be given local and intraperitoneal infiltration of local anesthetic before closure.They will also be given post operative patient controlled intravenous analgesia(PCIA) using tramadol. Receives: Procedure: Intra-peritoneal infiltration; Drug: PCIA Tramadol |
| Control group | Other | These patients will be given post operative analgesia in the form of patient controlled intravenous analgesia(PCIA) using tramadol. Neither local infiltration nor TAP block will be administered Receives: Drug: PCIA Tramadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total consumption of tramadol
Total consumption of tramadol post operatively
Measured: 12 hours post operatively
Secondary outcomes (5)
Pain score
Will be measured on a numerical rating scale which will be between 0-10
Measured: 12 hours post operatively
Respiratory depression
Less than 10 breaths per minute would be considered as respiratory depression
Measured: 12 hours post operatively
Nausea
Nausea and vomiting will be measured by verbal descriptive scale between 0-3
Measured: 12 hours post operatively
Sedation
Will be measured according to the following 0 Awake / alert. 1 Sleepy / responds appropriately. 2 Somnolent / arousable (light stimuli). 3 Deep sleep / rousable (deeper physical stimuli)
Measured: 12 hours post operatively
Patient satisfaction
7-point Likert scale (1=strongly disagree, 7=strong¬ly agree). Total satisfaction score was calculated from sum of response
Measured: 12 hours post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start20 Nov 2017
- Primary completion23 Jun 2020
- Study completion23 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pain, AcuteStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samina Ismail, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04037878
- Sponsor's protocol ID
- AgaKhan1
- Status last verified
- Jan 2021
- First submitted
- 20 Jun 2019
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Size M, Soyannwo OA, Justins DM. Pain management in developing countries. Anaesthesia. 2007 Dec;62 Suppl 1:38-43. doi: 10.1111/j.1365-2044.2007.05296.x.
PubMed 17937712Stanley G, Appadu B, Mead M, Rowbotham DJ. Dose requirements, efficacy and side effects of morphine and pethidine delivered by patient-controlled analgesia after gynaecological surgery. Br J Anaesth. 1996 Apr;76(4):484-6. doi: 10.1093/bja/76.4.484.
PubMed 8652316
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Consumption Following TAP Block Versus Intraperitoneal/Incisional Bupivicaine in Patients Undergoing Major Gynecologic Surgeries: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04037878
- Acronym / sponsor ID
- AgaKhan1
- Conditions
- Pain, Acute
- Keywords
- TAP block, Local infiltration, Tramadol, Gynecological surgery, Pain control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 23 Jun 2020 (actual)
- Study completion
- 23 Jun 2020 (actual)
- First posted
- 30 Jul 2019 (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.
It is a randomized controlled trial to determine the total tramadol consumption after major gynecological studies. Intervention groups include TAP block or local infiltration by the surgeon. These will be compared to a control group. Total tramadol consumption will be calculated and therefore pain control will be assessed.
Detailed description
All patients will receive standardized general anesthetic with standard monitoring. Anesthesia will be induced with intravenous (IV) tramadol (1milligram/kg), propofol (2 mg/kg) and atracurium 0.5mg/kg. Anaesthesia will be maintained with oxygen/air (40:60) with one MAC(Minimum Alveolar Concentration) of isoflurane.
TAP block will be performed for Group T patients before surgical incision with the help of an ultrasound and will be performed by two of the anesthesiologists who are part of this study. The study drug for the TAP block will be two syringes of 20 ml containing bupivacaine 0.25% with no other additives. For the infiltration group I, a 50ml syringe will contain 25ml of 0.5% Bupivacaine and 25ml of 5mics/ml epinephrine. These solutions will be made there and then by the anesthesiologist and the drugs for these solutions will be provided by the clinical trial unit. Allocation to group T, I and C will be according to the randomization block explained earlier. For group T, the US-guided TAP block technique will be similar to the method described by Hebbard and colleagues; (21) an ultrasound linear probe will be positioned in the mid-axillary line in the axial plane half-way between the iliac crest and the costal margin. Transversus abdominal plain will be located under ultrasound guidance. One ml test injection of the study solution will be permitted to confirm needle location. A total of 20ml of study solution will be injected on each side after aspiration to avoid intravascular placement. Surgical incision will be given after 20 minutes of TAP. Additional doses of Tramadol 10mg IV stat will be given on need basis (Rise of heart rate and blood pressure more than 20 % of baseline).
Towards the end of surgery, 50 ml of solution prepared by the anesthesiologist will be used for Group I. 50ml of 0.25% Bupivicaine with epinephrine will be poured into a sterile galley pot, from which the surgeon will draw up the solution. The surgeon will be asked to spray 10ml of this solution on to the pouch of Douglas, 10ml in the peritoneum, 10ml in the rectus sheath and 20ml in the skin.
The amount of Bupivicaine used for group I and T is less than the maximum safe dose which is 2.5mg per kg. Minimal side effects are reported using an ultrasound guided TAP block technique(22). If an immediate side effect is noted while performing the technique, treatment will be administered and the patient will be withdrawn from the study.
The control group (C) will receive the standard anesthesia and analgesia as mentioned above without any nerve block technique.
Prophylactic antiemetics in the form of ondansetron 4mg IV stat block and IV paracetamol 15mg/kg will be administered 30 minutes before the end of surgery and diclofenac 100 mg suppository will be administered at the end of surgery.
Routine monitoring of intraoperative blood pressures, heart rates, (base line, induction, surgical incision and at 10 minutes interval) administered fluid and drugs, surgical time and estimated blood loss will be recorded on intraoperative chart.
After completion of the surgical procedure, patients will be transferred to the post anesthesia care unit (PACU). A standardized postoperative analgesic regimen, consisting of regular rectal diclofenac 100 mg every 12 hours and oral paracetamol 1000mg every 6 hrs combined with IV PCIA Tramadol (no baseline infusion, demand bolus dose 15 mg, lock out 8 min), will be commenced on admission to the PACU for all 3 groups. Total tramadol consumption and side effects will be calculated at end of 12 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TAP block group | Experimental | Procedure: Transversus Abdominis Plane Block(TAP Block), Drug: PCIA TramadolPatients in this arm will be given Transversus Abdominal Plane(TAP) block after the induction of anesthesia. They will also be given post operative patient controlled intravenous analgesia(PCIA) using tramadol. |
| Local infiltration | Experimental | Procedure: Intra-peritoneal infiltration, Drug: PCIA TramadolPatients in this arm will be given local and intraperitoneal infiltration of local anesthetic before closure.They will also be given post operative patient controlled intravenous analgesia(PCIA) using tramadol. |
| Control group | Other | Drug: PCIA TramadolThese patients will be given post operative analgesia in the form of patient controlled intravenous analgesia(PCIA) using tramadol. Neither local infiltration nor TAP block will be administered |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Weight between 40 and 90kg
- ASA(American Society of Anesthesiologists) I to III
- Females scheduled for major gynecological surgeries(Abdominal hysterectomy, myomectomy, ovarian cystectomy, oophorectomy) through Pfannenstiel incision
Key exclusion criteria (6 listed)
- Refusal to participate in the study,
- History of drug allergy to bupivacaine, tramadol or other narcotics, addiction/ tolerance to opioids,
- Having bleeding disorders,
- Abdominal skin infections or open wounds/ abdominal drains,
- Previous history of failed TAP block,
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 |
|---|---|---|
| Transversus Abdominis Plane Block(TAP Block)Under ultrasound guidance, a 22 gauge stimuplex needle will be used to approach the transversus abdominis plane and 20ml of 0.25% Bupivicaine will be infiltrated into the TAP space. This procedure will be performed on either sides once anesthesia is induced. | Procedure or surgery | TAP block group |
| Intra-peritoneal infiltrationBefore skin closure, the surgeon will infiltrate the peritoneal cavity using a mixture of bupivicaine and epinephrine | Procedure or surgery | Local infiltration |
| PCIA TramadolAll patients will be given patient controlled intravenous analgesia using Tramadol as the drug | Drug | Control group, Local infiltration, TAP block group |
Primary outcome
Total consumption of tramadol
Time frame: 12 hours post operatively
Total consumption of tramadol post operatively
5 secondary outcomes
Pain score
Time frame: 12 hours post operatively
Respiratory depression
Time frame: 12 hours post operatively
Nausea
Time frame: 12 hours post operatively
Sedation
Time frame: 12 hours post operatively
Patient satisfaction
Time frame: 12 hours post operatively
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 15 Jan 2021.
- Background: PubMed 17937712Size M, Soyannwo OA, Justins DM. Pain management in developing countries. Anaesthesia. 2007 Dec;62 Suppl 1:38-43. doi: 10.1111/j.1365-2044.2007.05296.x.
- Results publication: PubMed 8652316Stanley G, Appadu B, Mead M, Rowbotham DJ. Dose requirements, efficacy and side effects of morphine and pethidine delivered by patient-controlled analgesia after gynaecological surgery. Br J Anaesth. 1996 Apr;76(4):484-6. doi: 10.1093/bja/76.4.484.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transversus Abdominis Plane Block(TAP Block), Intra-peritoneal infiltration and PCIA Tramadol in people with Pain, Acute, run by Aga Khan University at 1 site in Pakistan.
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 6 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 15 Jan 2021. 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 Pakistan. 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?
Total consumption of tramadol (time frame: 12 hours post operatively). 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 NCT04037878, which also lists 2 linked publications.
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 15 Jan 2021.