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Transversus Abdominis Plane Block Versus Wound Infiltration for Postcesarean Analgesia

Primary Purpose

Postcesarean Analgesia

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Spinal anesthesia
Intrathecal bupivacaine
Intrathecal fentanyl
Cesarean delivery
Wound infiltration
Sham procedure
Transversus abdominis plane block
Ketorolac
Paracetamol
Fentanyl patient-controlled analgesia
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postcesarean Analgesia

Eligibility Criteria

19 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. American Society of Anesthesiologists physical status II
  2. Full-term singleton pregnancy

Exclusion Criteria:

  1. Age <19 or > 40 years
  2. Height <150 cm
  3. Weight <60 kg
  4. Body mass index ≥40 kg/m2
  5. Contraindications to spinal anesthesia (patient refusal, increased intracranial tension, coagulopathy, uncorrected hypovolemia)
  6. Hypersensitivity to any of the drugs used in the study
  7. Significant cardiovascular, renal, or hepatic disease
  8. Known fetal abnormalities
  9. Emergency situations

Sites / Locations

  • Department of Anesthesia, Mansoura University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Wound Infiltration

Transversus abdominis plane block

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Cumulative Fentanyl Dose

Secondary Outcome Measures

Cumulative Fentanyl Dose
Time to the First Postoperative Fentanyl Administration
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.
Number of Patients With Nausea and/or Vomiting
The occurrence of nausea and/or vomiting will be observed and recorded.
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).
Number of Patients With Pruritis
The occurrence of pruritis will be assessed by yes/no question and recorded.
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).

Full Information

First Posted
February 16, 2016
Last Updated
March 30, 2018
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT02691572
Brief Title
Transversus Abdominis Plane Block Versus Wound Infiltration for Postcesarean Analgesia
Official Title
Comparison Between Transversus Abdominis Plane Block and Wound Infiltration for Analgesia After Cesarean Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postcesarean Analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wound Infiltration
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Transversus abdominis plane block
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Spinal anesthesia
Intervention Description
Performed at the L3-4 or L4-5 interspace using 27- or 25-gauge spinal needle.
Intervention Type
Drug
Intervention Name(s)
Intrathecal bupivacaine
Intervention Description
Bupivacaine 12.5 mg will be administered in the subarachnoid space.
Intervention Type
Drug
Intervention Name(s)
Intrathecal fentanyl
Intervention Description
Fentanyl 15 µg will be administered in the subarachnoid space.
Intervention Type
Procedure
Intervention Name(s)
Cesarean delivery
Intervention Description
Lower segment cesarean section using the Pfannenstiel incision and exteriorization of the uterus.
Intervention Type
Procedure
Intervention Name(s)
Wound infiltration
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sham procedure
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Transversus abdominis plane block
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Intervention Description
IV ketorolac 30 mg/8 h starting at the end of surgery.
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Intervention Description
Oral paracetamol 1 gm/8 h starting 4 h after surgery.
Intervention Type
Procedure
Intervention Name(s)
Fentanyl patient-controlled analgesia
Intervention Description
Intravenous fentanyl: bolus dose = 20 µg, lockout interval = 7 min, 4-h dose limit = 200 µg, with no background infusion.
Primary Outcome Measure Information:
Title
Cumulative Fentanyl Dose
Time Frame
24 h
Secondary Outcome Measure Information:
Title
Cumulative Fentanyl Dose
Time Frame
2, 4, 6, 12 h
Title
Time to the First Postoperative Fentanyl Administration
Time Frame
24 h
Title
Pain Scores at Rest and Movement
Description
Assessed using 11-point verbal rating scale (0 = no pain, 10 = the worst possible pain), at rest and movement.
Time Frame
2, 4, 6, 12, and 24 h
Title
Number of Patients With Nausea and/or Vomiting
Description
The occurrence of nausea and/or vomiting will be observed and recorded.
Time Frame
24 h
Title
Level of Sedation
Description
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).
Time Frame
24 h
Title
Number of Patients With Pruritis
Description
The occurrence of pruritis will be assessed by yes/no question and recorded.
Time Frame
24 h
Title
Level of Patient Satisfaction
Description
Assessed at 24 h using a 5-point scale (1 = very unsatisfied, 2 = unsatisfied, 3 = fair, 4 = satisfied, 5 = very satisfied).
Time Frame
24 h

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists physical status II Full-term singleton pregnancy Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed M Tawfik, MD
Organizational Affiliation
Mansoura University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesia, Mansoura University Hospitals
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Transversus Abdominis Plane Block Versus Wound Infiltration for Postcesarean Analgesia

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