Ain Shams University Maternity Hospital
Cairo, 11865, Egypt
NCT Number: NCT04711096
Adequate pain control after cesarean delivery is a major concern for both parturients and obstetrician, and it usually comprise a combination of systemic and regional techniques. The transversus abdominis plane (TAP) block, affecting the nerves supplying the anterior abdominal wall, is a recently introduced, promising regional analgesic technique for a variety of abdominal and pelvic surgeries including cesarean delivery .
Infiltration of local anesthetic into the surgical wound (either as a single shot or using indwelling catheters) has long been used for postoperative analgesia, Both the TAP block and wound infiltration, are superior to placebo, however, it is unknown which of them provides better analgesia after cesarean delivery because of a scarcity of randomized clinical trials.
This study aimed to compare bilateral US guidedTAP block with single-shot local anesthetic wound infiltration for analgesia after cesarean delivery performed under general anesthesia. The investigators hypothesized that the TAP block would decrease postoperative cumulative opioid consumption at 24 hours.
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Notify Me18 year–40 year
Female
Observational
Cairo, 11865, Egypt
The Anaesthesilogist is Senior staff trained on such procedure.
All mothers who scheduled for elective cesarean delivery who fulfilled inclusion criteria and volunteer are assessed by:
Postoperative pain by Numerical Rating Scale (NRS) pain score (range, 0-10; 0, no pain; 10, worst pain) on arrival in the post-labor ward (time 0) and at 2,4,6, 8, 12,18 and 24 hours postoperatively.
The duration of block (defined as the interval between performing the block and the time of the first request for analgesia) and total pethidine consumption were recorded in the 24 hours after surgery The level of patient satisfaction was measured numerically by a Likert scale ranging from one to five, 1: "not satisfied at all," 2: "slightly satisfied," 3: "moderately satisfied," 4: "very satisfied," and 5: "highly satisfied". Any adverse effects or complications will be recorded.
Intra-operative Setting
Group A: TAB group formed of 65 patients
Group B : The Infiltration Group formed of 65 patients.
Group C : Narcotics only group formed of 20 patients • routine analgesic was taken only without any intervention
Post operative settings:
Pain is usually managed by pethidine IV based on patient complain. the analgesic dose of pethidine will be 50 mg to be repeated on demand (NRS >4) provided that the total 24 hour dosage will not exceed 150 mg . At recovery room mothers asked to report their pain based on 11 point NRS score during first 24 hour. Patient satisfaction from postoperative analgesia will be assessed at 24 hours postoperatively using a 5-point scale (1 = very unsatisfied, 2 = unsatisfied, 3 = fair, 4 = satisfied,and 5 = very satisfied) after first hour, 2nd hour,4th hour, 6th hour, 12th hour and 24th hour at wards after end of surgery.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
After preparing the skin with antiseptic solution, a linear high frequency ultrasound probe will be placed abdominal wall between the iliac crest and the costal margin. A Spinal needle 22g attached with flexible tubing to a syringe filled with saline will be used to perform the block then introduced through the skin anteriorly in the plane between the internal oblique and transversus abdominis muscles with its tip lying in the mid axillary line. To assist with identifying these structures, The final position of the probe will to be no further anterior than the anterior axillary line. If satisfactory views are not obtained, the TAP block will not be performed. Hydro dissection with saline (2-5 ml) will be used to separate the fascial layers. After aspiration to exclude inadvertent vascular puncture, 20 ml of the 0.25% bupivacaine will be injected . TAP block will be performed in a similar fashion on the opposite side.
Other names: local wound infiltration
Time frame: 24 hours after the procedure
Assessment of pain involves asking a patient to rate her pain from 0 to 10 (11 point scale) with the understanding that 0 is equal to no pain and 10 equal to the worst possible pain after first hour, 2nd hour,4th hour, 6th hour, 12th hour and 24th hour at wards after end of surgery.
Time frame: 24 hours after the procedure
By asking the patients about the first time to analgesic request
Time frame: 24 hours after the procedure
By observation of first time to analgesia requested.
Time frame: 24 hours after the procedure
Observation of vital data in the first 24 hours postoperatively.
Time frame: 24 hours after the procedure
Patient satisfaction from postoperative analgesia will be assessed at 24 hours postoperatively using a 5-point scale (1 = very unsatisfied, 2 = unsatisfied, 3 = fair, 4 = satisfied,and 5 = very satisfied) after first hour, 2nd hour,4th hour, 6th hour, 12th hour and 24th hour at wards after end of surgery.
Ain Shams Maternity Hospital
Other
Ultrasound-guided Transversus Abdominis Plane (TAP) Block Versus Local Wound Infiltration for Post-operative Analgesia After Cesarean Section Under General Anesthesia.
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