Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study will compare the analgesic efficacy of transversus abdominis plane block and wound infiltration in parturients undergoing cesarean delivery under spinal anesthesia.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal anesthesia | Procedure | Performed at the L3-4 or L4-5 interspace using 27- or 25-gauge spinal needle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Fentanyl Dose | 24 h |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Fentanyl Dose | 2, 4, 6, 12 h | |
| Time to the First Postoperative Fentanyl Administration | 24 h | |
| Pain Scores at Rest and Movement |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mohamed M Tawfik, MD | Mansoura University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesia, Mansoura University Hospitals | Al Mansurah | Dakahlia Governorate | 35511 | Egypt |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Wound Infiltration | 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% was injected subcutaneously in the surgical wound (15 mL on the upper and lower sides) by the obstetrician before skin suturing. Sham procedure was performed after surgery. Standard analgesia (ketorolac and paracetamol) and fentanyl patient-controlled analgesia were administered postoperatively |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Intrathecal bupivacaine | Drug | Bupivacaine 12.5 mg will be administered in the subarachnoid space. |
|
| Intrathecal fentanyl | Drug | Fentanyl 15 µg will be administered in the subarachnoid space. |
|
| Cesarean delivery | Procedure | Lower segment cesarean section using the Pfannenstiel incision and exteriorization of the uterus. |
|
| Wound infiltration | Procedure | 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 | Procedure | 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 block | Procedure | 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. |
|
| Ketorolac | Drug | IV ketorolac 30 mg/8 h starting at the end of surgery. |
|
| Paracetamol | Drug | Oral paracetamol 1 gm/8 h starting 4 h after surgery. |
|
| Fentanyl patient-controlled analgesia | Procedure | Intravenous fentanyl: bolus dose = 20 µg, lockout interval = 7 min, 4-h dose limit = 200 µg, with no background infusion. |
|
Assessed using 11-point verbal rating scale (0 = no pain, 10 = the worst possible pain), at rest and movement. |
| 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. | 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). | 24 h |
| Number of Patients With Pruritis | The occurrence of pruritis will be assessed by yes/no question and recorded. | 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). | 24 h |
| FG001 | Transversus Abdominis Plane Block | 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 was performed using 20 mL bupivacaine 0.25% on each side. Standard analgesia (ketorolac and paracetamol) and fentanyl patient-controlled analgesia were administered postoperatively |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Wound Infiltration | 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% was injected subcutaneously in the surgical wound (15 mL on the upper and lower sides) by the obstetrician before skin suturing. Sham procedure was performed after surgery. Standard analgesia (ketorolac and paracetamol) and fentanyl patient-controlled analgesia were administered postoperatively |
| BG001 | Transversus Abdominis Plane Block | 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 was performed using 20 mL bupivacaine 0.25% on each side. Standard analgesia (ketorolac and paracetamol) and fentanyl patient-controlled analgesia were administered postoperatively |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Height | Mean | Standard Deviation | cm |
| |||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| Body mass index | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Gestational age | Median | Full Range | weeks |
| |||||||||||||||
| Nulliparous | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cumulative Fentanyl Dose | Posted | Mean | Standard Deviation | mcg | 24 h |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Cumulative Fentanyl Dose | Not Posted | 2, 4, 6, 12 h | Participants | |||||||||||||||||||||||||||||||||||
| Secondary | Time to the First Postoperative Fentanyl Administration | Not Posted | 24 h | Participants | |||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | 2, 4, 6, 12, and 24 h | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Nausea and/or Vomiting | The occurrence of nausea and/or vomiting will be observed and recorded. | Not Posted | 24 h | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | 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). | Not Posted | 24 h | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Pruritis | The occurrence of pruritis will be assessed by yes/no question and recorded. | Not Posted | 24 h | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | 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). | Not Posted | 24 h | Participants |
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Wound Infiltration | 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% was injected subcutaneously in the surgical wound (15 mL on the upper and lower sides) by the obstetrician before skin suturing. Sham procedure was performed after surgery. Standard analgesia (ketorolac and paracetamol) and fentanyl patient-controlled analgesia were administered postoperatively | 0 | 39 | 0 | 39 | ||
| EG001 | Transversus Abdominis Plane Block | 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 was performed using 20 mL bupivacaine 0.25% on each side. Standard analgesia (ketorolac and paracetamol) and fentanyl patient-controlled analgesia were administered postoperatively | 0 | 39 | 0 | 39 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mohamed Mohamed Tawfik | Department of Anesthesia and Surgical Intensive Care, Mansoura University Hospitals, Mansoura, Egypt. | 1001183400 | 0020 | m2tawfik@mans.edu.eg |
| ID | Term |
|---|---|
| D000775 | Anesthesia, Spinal |
| D002585 | Cesarean Section |
| D020910 | Ketorolac |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D036861 | Delivery, Obstetric |
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
Not provided
Not provided
| Male |
|