Transversus Abdominis Plane Block Versus Wound Infiltration for Postcesarean Analgesia
Comparison Between Transversus Abdominis Plane Block and Wound Infiltration for Analgesia After Cesarean Delivery
1 other identifier
interventional
80
1 country
1
Brief Summary
The study will compare the analgesic efficacy of transversus abdominis plane block and wound infiltration in parturients undergoing cesarean delivery under spinal anesthesia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 16, 2016
CompletedFirst Posted
Study publicly available on registry
February 25, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedResults Posted
Study results publicly available
October 31, 2018
CompletedOctober 31, 2018
May 1, 2016
3 months
February 16, 2016
March 30, 2018
March 30, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Cumulative Fentanyl Dose
24 h
Secondary Outcomes (7)
Cumulative Fentanyl Dose
2, 4, 6, 12 h
Time to the First Postoperative Fentanyl Administration
24 h
Pain Scores at Rest and Movement
2, 4, 6, 12, and 24 h
Number of Patients With Nausea and/or Vomiting
24 h
Level of Sedation
24 h
- +2 more secondary outcomes
Study Arms (2)
Wound Infiltration
ACTIVE COMPARATORCesarean 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
EXPERIMENTALCesarean 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.
Interventions
Performed at the L3-4 or L4-5 interspace using 27- or 25-gauge spinal needle.
Bupivacaine 12.5 mg will be administered in the subarachnoid space.
Fentanyl 15 µg will be administered in the subarachnoid space.
Lower segment cesarean section using the Pfannenstiel incision and exteriorization of the uterus.
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 by moving the ultrasound probe and pressing a covered spinal needle on both sides of the patients' abdomen.
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.
IV ketorolac 30 mg/8 h starting at the end of surgery.
Oral paracetamol 1 gm/8 h starting 4 h after surgery.
Intravenous fentanyl: bolus dose = 20 µg, lockout interval = 7 min, 4-h dose limit = 200 µg, with no background infusion.
Eligibility Criteria
You may qualify if:
- American Society of Anesthesiologists physical status II
- Full-term singleton pregnancy
You may not qualify if:
- 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
- Significant cardiovascular, renal, or hepatic disease
- Known fetal abnormalities
- Emergency situations
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesia, Mansoura University Hospitals
Al Mansurah, Dakahlia Governorate, 35511, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Mohamed Mohamed Tawfik
- Organization
- Department of Anesthesia and Surgical Intensive Care, Mansoura University Hospitals, Mansoura, Egypt.
Study Officials
- PRINCIPAL INVESTIGATOR
Mohamed M Tawfik, MD
Mansoura University Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer
Study Record Dates
First Submitted
February 16, 2016
First Posted
February 25, 2016
Study Start
February 1, 2016
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
October 31, 2018
Results First Posted
October 31, 2018
Record last verified: 2016-05
Data Sharing
- IPD Sharing
- Will not share