Transversus Abdominis Plane Block Versus Wound Infiltration for Postcesarean Analgesia

NCT ID: NCT02691572

Last Updated: 2018-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2016-05-31

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.

Conditions

Postcesarean Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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% 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.

Group Type: ACTIVE_COMPARATOR

Spinal anesthesia

Intervention Type: PROCEDURE

Performed at the L3-4 or L4-5 interspace using 27- or 25-gauge spinal needle.

Intrathecal bupivacaine

Intervention Type: DRUG

Bupivacaine 12.5 mg will be administered in the subarachnoid space.

Intrathecal fentanyl

Intervention Type: DRUG

Fentanyl 15 µg will be administered in the subarachnoid space.

Cesarean delivery

Intervention Type: PROCEDURE

Lower segment cesarean section using the Pfannenstiel incision and exteriorization of the uterus.

Wound infiltration

Intervention Type: 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

Intervention Type: 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.

Ketorolac

Intervention Type: DRUG

IV ketorolac 30 mg/8 h starting at the end of surgery.

Paracetamol

Intervention Type: DRUG

Oral paracetamol 1 gm/8 h starting 4 h after surgery.

Fentanyl patient-controlled analgesia

Intervention Type: PROCEDURE

Intravenous fentanyl: bolus dose = 20 µg, lockout interval = 7 min, 4-h dose limit = 200 µg, with no background infusion.

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 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.

Group Type: EXPERIMENTAL

Spinal anesthesia

Intervention Type: PROCEDURE

Performed at the L3-4 or L4-5 interspace using 27- or 25-gauge spinal needle.

Intrathecal bupivacaine

Intervention Type: DRUG

Bupivacaine 12.5 mg will be administered in the subarachnoid space.

Intrathecal fentanyl

Intervention Type: DRUG

Fentanyl 15 µg will be administered in the subarachnoid space.

Cesarean delivery

Intervention Type: PROCEDURE

Lower segment cesarean section using the Pfannenstiel incision and exteriorization of the uterus.

Transversus abdominis plane block

Intervention Type: 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

Intervention Type: DRUG

IV ketorolac 30 mg/8 h starting at the end of surgery.

Paracetamol

Intervention Type: DRUG

Oral paracetamol 1 gm/8 h starting 4 h after surgery.

Fentanyl patient-controlled analgesia

Intervention Type: PROCEDURE

Intravenous fentanyl: bolus dose = 20 µg, lockout interval = 7 min, 4-h dose limit = 200 µg, with no background infusion.

Interventions

Spinal anesthesia

Performed at the L3-4 or L4-5 interspace using 27- or 25-gauge spinal needle.

Intervention Type: PROCEDURE

Intrathecal bupivacaine

Bupivacaine 12.5 mg will be administered in the subarachnoid space.

Intervention Type: DRUG

Intrathecal fentanyl

Fentanyl 15 µg will be administered in the subarachnoid space.

Intervention Type: DRUG

Cesarean delivery

Lower segment cesarean section using the Pfannenstiel incision and exteriorization of the uterus.

Intervention Type: PROCEDURE

Wound infiltration

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

Sham 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.

Intervention Type: PROCEDURE

Transversus abdominis plane block

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: PROCEDURE

Ketorolac

IV ketorolac 30 mg/8 h starting at the end of surgery.

Intervention Type: DRUG

Paracetamol

Oral paracetamol 1 gm/8 h starting 4 h after surgery.

Intervention Type: DRUG

Fentanyl patient-controlled analgesia

Intravenous fentanyl: bolus dose = 20 µg, lockout interval = 7 min, 4-h dose limit = 200 µg, with no background infusion.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Mohamed Tawfik

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed M Tawfik, MD

Role: PRINCIPAL_INVESTIGATOR

Mansoura University Hospital

Locations

Department of Anesthesia, Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, Egypt

Countries

Egypt

Other Identifiers

R/16.01.17

Identifier Type: -

Identifier Source: org_study_id