Postcesarean AnalgesiaNCT02691572
Transversus Abdominis Plane Block Versus Wound Infiltration for Postcesarean Analgesia
A study testing Spinal anesthesia, Intrathecal bupivacaine and Intrathecal fentanyl in people with Postcesarean Analgesia, run by Mansoura University at 1 site in Egypt.
Trial summary
The study will compare the analgesic efficacy of transversus abdominis plane block and wound infiltration in parturients undergoing cesarean delivery under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 19 to 40 years, women only
- Conditions the study is for
- Postcesarean Analgesia
- What is being tested?
- Spinal anesthesia, Intrathecal bupivacaine and Intrathecal fentanyl
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2016to May 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists physical status II
- Full-term singleton pregnancy
Who cannot join
- Age <19 or > 40 years
- Height <150 cm
- Weight <60 kg
- Body mass index ≥40 kg/m2
- Contraindications to spinal anesthesia (patient refusal, increased intracranial tension, coagulopathy, uncorrected hypovolemia)
- Hypersensitivity to any of the drugs used in the study
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- Significant cardiovascular, renal, or hepatic disease
- Known fetal abnormalities
- Emergency situations
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Anesthesia, Mansoura University Hospitals
Al Mansurah, Dakahlia Governorate, 35511
About this study
Official title: Comparison Between Transversus Abdominis Plane Block and Wound Infiltration for Analgesia After Cesarean Delivery
The study will compare the analgesic efficacy of transversus abdominis plane block and wound infiltration in parturients undergoing cesarean delivery under spinal anesthesia.
Read the detailed description
This randomized, controlled, double-blind study will be conducted on ASA physical status II parturients with full-term singleton pregnancy undergoing elective cesarean delivery under spinal anesthesia. Patients will receive either ultrasound-guided transversus abdominis plane block or wound infiltration at the end of surgery. After delivery, all patients will receive standard analgesia (intravenous ketorolac and oral paracetamol) and patient-controlled analgesia with intravenous fentanyl. Total fentanyl consumption at 24 h, pain scores at 2, 4, 6, 12, and 24 h, side effects, and patient satisfaction will be compared between the 2 groups.
- Conditions
- Postcesarean Analgesia
- Being tested
- Spinal anesthesia, Intrathecal bupivacaine, Intrathecal fentanyl, Cesarean delivery, Wound infiltration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal anesthesiaProcedure or surgery
Performed at the L3-4 or L4-5 interspace using 27- or 25-gauge spinal needle.
Intrathecal bupivacaineDrug
Bupivacaine 12.5 mg will be administered in the subarachnoid space.
Intrathecal fentanylDrug
Fentanyl 15 µg will be administered in the subarachnoid space.
Cesarean deliveryProcedure or surgery
Lower segment cesarean section using the Pfannenstiel incision and exteriorization of the uterus.
Wound infiltrationProcedure or surgery
30 mL bupivacaine 0.25% will be injected subcutaneously in the surgical wound (15 mL on the upper and lower sides) by the obstetrician before skin suturing.
Sham procedureProcedure or surgery
Sham procedure will be performed after surgery by moving the ultrasound probe and pressing a covered spinal needle on both sides of the patients' abdomen.
Transversus abdominis plane blockProcedure or surgery
Bilateral ultrasound-guided TAP block using 20 mL bupivacaine 0.25% on each side. A 7-12 MHz linear array probe and 22-gauge needle will be used. The probe will be placed transversely above the iliac crest in the anterior axillary line and the needle will be introduced in-plane with the probe from medial to lateral.
KetorolacDrug
IV ketorolac 30 mg/8 h starting at the end of surgery.
ParacetamolDrug
Oral paracetamol 1 gm/8 h starting 4 h after surgery.
Fentanyl patient-controlled analgesiaProcedure or surgery
Intravenous fentanyl: bolus dose = 20 µg, lockout interval = 7 min, 4-h dose limit = 200 µg, with no background infusion.
| Study group | Role | What they receive |
|---|---|---|
| Wound Infiltration | Active comparator | Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). At the end of surgery, 30 mL bupivacaine 0.25% will be injected subcutaneously in the surgical wound (15 mL on the upper and lower sides) by the obstetrician before skin suturing. Sham procedure will be performed after surgery. Standard analgesia (ketorolac and paracetamol) and fentanyl patient-controlled analgesia will be administered postoperatively. Receives: Procedure: Spinal anesthesia; Drug: Intrathecal bupivacaine; Drug: Intrathecal fentanyl; Procedure: Cesarean delivery; Procedure: Wound infiltration; Procedure: Sham procedure; Drug: Ketorolac; Drug: Paracetamol; Procedure: Fentanyl patient-controlled analgesia |
| Transversus abdominis plane block | Experimental | Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). After completion of surgery, bilateral ultrasound-guided TAP block will be performed using 20 mL bupivacaine 0.25% on each side. Standard analgesia (ketorolac and paracetamol) and fentanyl patient-controlled analgesia will be administered postoperatively. Receives: Procedure: Spinal anesthesia; Drug: Intrathecal bupivacaine; Drug: Intrathecal fentanyl; Procedure: Cesarean delivery; Procedure: Transversus abdominis plane block; Drug: Ketorolac; Drug: Paracetamol; Procedure: Fentanyl patient-controlled analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Fentanyl Dose
Measured: 24 h
Secondary outcomes (7)
Cumulative Fentanyl Dose
Measured: 2, 4, 6, 12 h
Time to the First Postoperative Fentanyl Administration
Measured: 24 h
Pain Scores at Rest and Movement
Assessed using 11-point verbal rating scale (0 = no pain, 10 = the worst possible pain), at rest and movement.
Measured: 2, 4, 6, 12, and 24 h
Number of Patients With Nausea and/or Vomiting
The occurrence of nausea and/or vomiting will be observed and recorded.
Measured: 24 h
Level of Sedation
Assessed using a 4-point scale (1 = awake and alert, 2 = minimally sedated, responds to speech, 3 = moderately sedated, rousable by tactile stimulation, 4 = deeply sedated, rousable only with painful stimulation).
Measured: 24 h
Number of Patients With Pruritis
The occurrence of pruritis will be assessed by yes/no question and recorded.
Measured: 24 h
Level of Patient Satisfaction
Assessed at 24 h using a 5-point scale (1 = very unsatisfied, 2 = unsatisfied, 3 = fair, 4 = satisfied, 5 = very satisfied).
Measured: 24 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postcesarean AnalgesiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mohamed Tawfik, Mansoura University
- Investigators
- Mohamed M Tawfik, MD, Principal investigator, Mansoura University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02691572
- Sponsor's protocol ID
- R/16.01.17
- Status last verified
- May 2016
- First submitted
- 16 Feb 2016
- Last updated
- 31 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Transversus Abdominis Plane Block and Wound Infiltration for Analgesia After Cesarean Delivery
- ClinicalTrials.gov ID
- NCT02691572
- Acronym / sponsor ID
- R/16.01.17
- Conditions
- Postcesarean Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 25 Feb 2016 (estimated)
- Results
- Posted 31 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will compare the analgesic efficacy of transversus abdominis plane block and wound infiltration in parturients undergoing cesarean delivery under spinal anesthesia.
Detailed description
This randomized, controlled, double-blind study will be conducted on ASA physical status II parturients with full-term singleton pregnancy undergoing elective cesarean delivery under spinal anesthesia. Patients will receive either ultrasound-guided transversus abdominis plane block or wound infiltration at the end of surgery. After delivery, all patients will receive standard analgesia (intravenous ketorolac and oral paracetamol) and patient-controlled analgesia with intravenous fentanyl. Total fentanyl consumption at 24 h, pain scores at 2, 4, 6, 12, and 24 h, side effects, and patient satisfaction will be compared between the 2 groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wound Infiltration | Active comparator | Procedure: Spinal anesthesia, Drug: Intrathecal bupivacaine, Drug: Intrathecal fentanyl, Procedure: Cesarean delivery, Procedure: Wound infiltration, Procedure: Sham procedure, Drug: Ketorolac, Drug: Paracetamol, Procedure: Fentanyl patient-controlled analgesiaCesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). At the end of surgery, 30 mL bupivacaine 0.25% will be injected subcutaneously in the surgical wound (15 mL on the upper and lower sides) by the obstetrician before skin suturing. Sham procedure will be performed after surgery. Standard analgesia (ketorolac and paracetamol) and fentanyl patient-controlled analgesia will be administered postoperatively. |
| Transversus abdominis plane block | Experimental | Procedure: Spinal anesthesia, Drug: Intrathecal bupivacaine, Drug: Intrathecal fentanyl, Procedure: Cesarean delivery, Procedure: Transversus abdominis plane block, Drug: Ketorolac, Drug: Paracetamol, Procedure: Fentanyl patient-controlled analgesiaCesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). After completion of surgery, bilateral ultrasound-guided TAP block will be performed using 20 mL bupivacaine 0.25% on each side. Standard analgesia (ketorolac and paracetamol) and fentanyl patient-controlled analgesia will be administered postoperatively. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists physical status II
- Full-term singleton pregnancy
Key exclusion criteria (9 listed)
- Age <19 or > 40 years
- Height <150 cm
- Weight <60 kg
- Body mass index ≥40 kg/m2
- Contraindications to spinal anesthesia (patient refusal, increased intracranial tension, coagulopathy, uncorrected hypovolemia)
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 |
|---|---|---|
| Spinal anesthesiaPerformed at the L3-4 or L4-5 interspace using 27- or 25-gauge spinal needle. | Procedure or surgery | Transversus abdominis plane block, Wound Infiltration |
| Intrathecal bupivacaineBupivacaine 12.5 mg will be administered in the subarachnoid space. | Drug | Transversus abdominis plane block, Wound Infiltration |
| Intrathecal fentanylFentanyl 15 µg will be administered in the subarachnoid space. | Drug | Transversus abdominis plane block, Wound Infiltration |
| Cesarean deliveryLower segment cesarean section using the Pfannenstiel incision and exteriorization of the uterus. | Procedure or surgery | Transversus abdominis plane block, Wound Infiltration |
| Wound infiltration30 mL bupivacaine 0.25% will be injected subcutaneously in the surgical wound (15 mL on the upper and lower sides) by the obstetrician before skin suturing. | Procedure or surgery | Wound Infiltration |
| Sham procedureSham procedure will be performed after surgery by moving the ultrasound probe and pressing a covered spinal needle on both sides of the patients' abdomen. | Procedure or surgery | Wound Infiltration |
| Transversus abdominis plane blockBilateral ultrasound-guided TAP block using 20 mL bupivacaine 0.25% on each side. A 7-12 MHz linear array probe and 22-gauge needle will be used. The probe will be placed transversely above the iliac crest in the anterior axillary line and the needle will be introduced in-plane with the probe from medial to lateral. | Procedure or surgery | Transversus abdominis plane block |
| KetorolacIV ketorolac 30 mg/8 h starting at the end of surgery. | Drug | Transversus abdominis plane block, Wound Infiltration |
| ParacetamolOral paracetamol 1 gm/8 h starting 4 h after surgery. | Drug | Transversus abdominis plane block, Wound Infiltration |
| Fentanyl patient-controlled analgesiaIntravenous fentanyl: bolus dose = 20 µg, lockout interval = 7 min, 4-h dose limit = 200 µg, with no background infusion. | Procedure or surgery | Transversus abdominis plane block, Wound Infiltration |
Primary outcome
Cumulative Fentanyl Dose
Time frame: 24 h
7 secondary outcomes
Cumulative Fentanyl Dose
Time frame: 2, 4, 6, 12 h
Time to the First Postoperative Fentanyl Administration
Time frame: 24 h
Pain Scores at Rest and Movement
Time frame: 2, 4, 6, 12, and 24 h
Number of Patients With Nausea and/or Vomiting
Time frame: 24 h
Level of Sedation
Time frame: 24 h
Number of Patients With Pruritis
Time frame: 24 h
Level of Patient Satisfaction
Time frame: 24 h
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Mohamed M Tawfik, MD principal investigator
Mansoura University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal anesthesia, Intrathecal bupivacaine and Intrathecal fentanyl in people with Postcesarean Analgesia, 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 9 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 31 Oct 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. 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?
Yes. Results are posted in the registry (first posted 31 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cumulative Fentanyl Dose (time frame: 24 h). 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 31 Oct 2018.