Effect of TAP Block on Time Required for First Analgesic Dose After Cesarean Cection Under Spinal Anesthesia

NCT04623632 | Completed Phase 2 DMC

• 1 other identifier: 3
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

While opioids are the mainstay for post-operative analgesia after caesarean section, they are associated with various side effects. Ultrasound guided transversusabdominis plane (TAP) block has been postulated to provide effective analgesia for caesarean section. However a new technique in TAP block is described which can be used safely by a beginner without any fear of complication whichwill help in providing good postoperative analgesia to maximumnumber of patients. This study will evaluate the analgesic efficacy of TAP block using Modified Surgeon Assisted Bilateral TAP block for post caesarean analgesia in a randomized controlled trial.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Time to the first opioid analgesic request

  when will the patient ask for opioid analgesia after cesarean section

  First 24hours after cesarean section

Secondary Outcomes (1)

• Total analgesic requirements in 24 hours Total opioid analgesic requirements in 24 hours

  first 24hours after cesarean section

Study Arms (2)

Bupivacaine

ACTIVE COMPARATOR

the landmark is at the level of umbilicus 8 to 10 cms from midline bilaterally. A tiny nick is made in the skin with a 18G sharp needle to obliterate the cushion effect. Then an 18 G Tuohy needle will be insert perpendicular to skin directing the needle slightly towards the ipsilateral anterior superior iliac spine just before the closure of peritoneum. After feeling 2 pops of external and internal oblique aponeurosis the drug will be injected after aspiration. The injectate syringes will be prepared under aseptic technique; syringes contained bupivacaine 0.25% 40 ml. Once the plane is reached the surgeon places his hand inside the abdominal cavity at the level of needle insertion to reconfirm needle placement. A bleb is palpated by the surgeon as the injection continues. The back flow of drug after injection is one of the signs that drug has been deposited in the TAP plane

Drug: Transversus abdominus plane block

Placebo

PLACEBO COMPARATOR

the landmark is at the level of umbilicus 8 to 10 cms from midline bilaterally. A tiny nick is made in the skin with a 18G sharp needle to obliterate the cushion effect. Then an 18 G Tuohy needle will be insert perpendicular to skin directing the needle slightly towards the ipsilateral anterior superior iliac spine just before the closure of peritoneum. After feeling 2 pops of external and internal oblique aponeurosis the drug will be injected after aspiration. The injectate syringes will be prepared under aseptic technique syringes contained either normal saline 40 ml. Once the plane is reached the surgeon places his hand inside the abdominal cavity at the level of needle insertion to reconfirm needle placement. A bleb is palpated by the surgeon as the injection continues. The back flow of drug after injection is one of the signs that drug has been deposited in the TAP plane

Drug: Transversus abdominus plane placebo

Interventions

Transversus abdominus plane block DRUG

transversus abdominus plane block using 40 ml of bupivacaine 0.25%

Also known as: Regional analgesia

Bupivacaine

Transversus abdominus plane placebo DRUG

injection of 40 ml of normal saline in the transversus abdominus plane

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists (ASA) class I-II
• Normal singleton pregnancy.
• With a gestational age of completed 37 weeks or more.
• Category ІV cesarean section

You may not qualify if:

• Under the age of 18 or older than 40 years.
• Obese patients with a BMI \>40.
• ASA III or ASA IV risk groups
• Patients with contraindications to spinal anesthesia or history of allergy to bupivacaine.
• patients who received analgesics in the past 24 hours
• Infection in the region where the block would be performed.
• Category І- Ц- Ш cesarean section
• Refusal to participate in the study

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

AinShams university maternity hospital

Cairo, Egypt

Location

Related Publications (7)

• 1. Ahmad M, Furqan A, Adnan M, Waris S and Yousuf M (2019):

  BACKGROUND

• Canakci E, Gultekin A, Cebeci Z, Hanedan B, Kilinc A. The Analgesic Efficacy of Transverse Abdominis Plane Block versus Epidural Block after Caesarean Delivery: Which One Is Effective? TAP Block? Epidural Block? Pain Res Manag. 2018 Oct 17;2018:3562701. doi: 10.1155/2018/3562701. eCollection 2018.

  PMID: 30416635 BACKGROUND

• Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.

  PMID: 26225500 BACKGROUND

• McMorrow RC, Ni Mhuircheartaigh RJ, Ahmed KA, Aslani A, Ng SC, Conrick-Martin I, Dowling JJ, Gaffney A, Loughrey JP, McCaul CL. Comparison of transversus abdominis plane block vs spinal morphine for pain relief after Caesarean section. Br J Anaesth. 2011 May;106(5):706-12. doi: 10.1093/bja/aer061.

  PMID: 21498494 BACKGROUND

• Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.

  PMID: 6226917 BACKGROUND

• 6. Roy R and Pattnaik S (2016):

  BACKGROUND

• 7. Sriramka B, Sahoo N and Panigrahi S (2012):

  BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Adel Shafik, MD

  AinShams university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of obstetrics and gynecology - faculty of medicine - Ainshams university

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 10, 2020
• Study Start: September 20, 2020
• Primary Completion: March 20, 2021
• Study Completion: March 20, 2021
• Last Updated: December 23, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)