Ultrasound-guided TAP Block Vs Local Wound Infiltration for Analgesia After Cesarean Section.

NCT04711096 | Unknown DMC

• 1 other identifier: Post Cesarean TAP Block
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain Control

Keywords

Post Cesarean TAP Block; TAB block; Postoperative Pain control

Outcome Measures

Primary Outcomes (2)

• Postoperative pain severity assessed by the Numerical Rating Scale (NRS) pain score at 1,2,4,6, 12, and 24 hours

  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.

  24 hours after the procedure

• The duration of analgesia achieved by each type of block assessed by the time of first postoperative pethidine dose required.

  By asking the patients about the first time to analgesic request

  24 hours after the procedure

Secondary Outcomes (3)

• Cumulative pethidine consumption at 2, 4, 6, and 12 hours, NRS at 0, 4, 6, 12, and 24 hours.

  24 hours after the procedure

• the incidence of side effects and Toxicity (nausea and vomiting and pruritis).

  24 hours after the procedure

• Patient Satisfaction

  24 hours after the procedure

Study Arms (3)

Group A

TAB group formed of 65 patients

Procedure: Ultrasound-guided transversus abdominis plane (TAP) block 0.25% bupivacaine.

Group B

Group B : The Infiltration Group formed of 65 patients. • This group will B wills provided with single-shot local anesthetic wound infiltration with 20 ml of 0.25% bupivacaine injected subcutaneously above and below skin incision before closure of skin.

Procedure: Ultrasound-guided transversus abdominis plane (TAP) block 0.25% bupivacaine.

Group C

Group C : Narcotics only group formed of 20 patients • routine analgesic was taken only without any intervention

Interventions

Ultrasound-guided transversus abdominis plane (TAP) block 0.25% bupivacaine. PROCEDURE

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.

Also known as: local wound infiltration

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study subjects will randomly assigned to 3 equal groups (TAP group and infiltration group and Narcotics only group) of patients undergoing elective cesarean section under general anathesia in Ain Shams Maternity hospital

You may qualify if:

• Patients undergoing elective cesarean section under general anathesia
• Pfannenstiel Skin Incision
• Age between 18 and 40 years old
• BMI between 18 and 35 kg/m2

You may not qualify if:

• Patient refusal.
• BMI\<18 kg/m2 or\>35 (require different dose of analgesia)
• Height \<150 or \> 180 cm (require different dose of analgesia)
• Patients with any neurological deficit due to neuropathy and pain score affection
• Patients with bleeding disorders which may lead to hematoma
• HTN (Vasculopathy which can lead to hematoma).
• Cardiac disease ( Vasculopathy on anticoagulant which can lead to hematoma)
• DM (decrease systemic and local immunity which can lead to abscess at injection site and due to neuropathy and pain score affection).
• Liver disease (defective clotting factors).
• A history of relevant drug allergy or Hypersensitivity to any of the drugs used in the study due to impair of proper follow up of pain postoperative
• History of recent opioid exposure due to affection on pain score
• Local skin infection due to abscess formation
• Obstetric complications e.g placenta previa and rupture uterus due to extensive tissue damage and dissection

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

Ain Shams University Maternity Hospital

Cairo, 11865, Egypt

RECRUITING

Related Publications (12)

• Adesope O, Ituk U, Habib AS. Local anaesthetic wound infiltration for postcaesarean section analgesia: A systematic review and meta-analysis. Eur J Anaesthesiol. 2016 Oct;33(10):731-42. doi: 10.1097/EJA.0000000000000462.

  PMID: 27259092 RESULT

• Bamigboye AA, Hofmeyr GJ. Local anaesthetic wound infiltration and abdominal nerves block during caesarean section for postoperative pain relief. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD006954. doi: 10.1002/14651858.CD006954.pub2.

  PMID: 19588413 RESULT

• Fusco P, Scimia P, Paladini G, Fiorenzi M, Petrucci E, Pozone T, Vacca F, Behr A, Micaglio M, Danelli G, Cofini V, Necozione S, Carta G, Petrini F, Marinangeli F. Transversus abdominis plane block for analgesia after Cesarean delivery. A systematic review. Minerva Anestesiol. 2015 Feb;81(2):195-204. Epub 2014 Apr 16.

  PMID: 24739207 RESULT

• Elamin G, Waters PS, Hamid H, O'Keeffe HM, Waldron RM, Duggan M, Khan W, Barry MK, Khan IZ. Efficacy of a Laparoscopically Delivered Transversus Abdominis Plane Block Technique during Elective Laparoscopic Cholecystectomy: A Prospective, Double-Blind Randomized Trial. J Am Coll Surg. 2015 Aug;221(2):335-44. doi: 10.1016/j.jamcollsurg.2015.03.030. Epub 2015 Mar 27.

  PMID: 25899736 RESULT

• Lapmahapaisan S, Tantemsapya N, Aroonpruksakul N, Maisat W, Suraseranivongse S. Efficacy of surgical transversus abdominis plane block for postoperative pain relief following abdominal surgery in pediatric patients. Paediatr Anaesth. 2015 Jun;25(6):614-20. doi: 10.1111/pan.12607. Epub 2015 Jan 9.

  PMID: 25571981 RESULT

• Kiran LV, Sivashanmugam T, Kumar VRH, Krishnaveni N, Parthasarathy S. Relative Efficacy of Ultrasound-guided Ilioinguinal-iliohypogastric Nerve Block versus Transverse Abdominis Plane Block for Postoperative Analgesia following Lower Segment Cesarean Section: A Prospective, Randomized Observer-blinded Trial. Anesth Essays Res. 2017 Jul-Sep;11(3):713-717. doi: 10.4103/0259-1162.206855.

  PMID: 28928576 RESULT

• Mankikar MG, Sardesai SP, Ghodki PS. Ultrasound-guided transversus abdominis plane block for post-operative analgesia in patients undergoing caesarean section. Indian J Anaesth. 2016 Apr;60(4):253-7. doi: 10.4103/0019-5049.179451.

  PMID: 27141108 RESULT

• McDonnell NJ, Keating ML, Muchatuta NA, Pavy TJ, Paech MJ. Analgesia after caesarean delivery. Anaesth Intensive Care. 2009 Jul;37(4):539-51. doi: 10.1177/0310057X0903700418.

  PMID: 19681409 RESULT

• Mishriky BM, George RB, Habib AS. Transversus abdominis plane block for analgesia after Cesarean delivery: a systematic review and meta-analysis. Can J Anaesth. 2012 Aug;59(8):766-78. doi: 10.1007/s12630-012-9729-1. Epub 2012 May 24.

  PMID: 22622954 RESULT

• Aydogmus M, Sinikoglu S, Naki M, Ocak N, Sanli N, Alagol A. Comparison of analgesic efficiency between wound site infiltration and ultra-sound-guided transversus abdominis plane block after cesarean delivery under spinal anaesthesia. Hippokratia. 2014 Jan;18(1):28-31.

  PMID: 25125948 RESULT

• Mudgalkar N, Bele SD, Valsangkar S, Bodhare TN, Gorre M. Utility of numerical and visual analog scales for evaluating the post-operative pain in rural patients. Indian J Anaesth. 2012 Nov;56(6):553-7. doi: 10.4103/0019-5049.104573.

  PMID: 23325940 RESULT

• Sharkey A, Finnerty O, McDonnell JG. Role of transversus abdominis plane block after caesarean delivery. Curr Opin Anaesthesiol. 2013 Jun;26(3):268-72. doi: 10.1097/ACO.0b013e328360fa16.

  PMID: 23587731 RESULT

MeSH Terms

Interventions

Dental Occlusion; Bupivacaine

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Rehab Abdel Rahman, Prof

  Ain Shams Maternity Hospital

  STUDY DIRECTOR

Central Study Contacts

Mostafa Bakry, Master

CONTACT

01008618768; MostafaBakry9090@gmail.com

Rehab Abdel Rahman, Prof

CONTACT

01004992772; Rehababdulrahman.rm@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The principal investigator

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 15, 2021
• Study Start: January 1, 2021
• Primary Completion: June 30, 2021
• Study Completion: September 30, 2021
• Last Updated: January 19, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)