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

• ClinicalTrials.gov Identifier: NCT04623632
• Recruitment Status: Recruiting
• First Posted: November 10, 2020
• Last Update Posted: January 5, 2021
• Sponsor: Ain Shams Maternity Hospital
• Information provided by (Responsible Party): Ahmed Mohammed Elmaraghy, Ain Shams Maternity Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Postoperative Pain	Drug: Transversus abdominus plane block; Drug: Transversus abdominus plane placebo	Phase 2

Detailed Description:

Acute severe pain after cesarean delivery is frequent. At least 10 to 15% of the women develop chronic pain .Effective postoperative analgesia after caesarean section is important because it enables early ambulation and facilitates breast-feeding.

The administration of opioids, local blocks and other analgesic medication is instituted to decrease the duration and intensity of postoperative pain as a part of a multimodal analgesic regimen. The transversusabdominis plane (TAP) block is a regional analgesic technique which blocks T6-L1 nerve branches and has an evolving role in postoperative analgesia for lower abdominal surgeries .

In postoperative analgesia, efficacy of TAP block is equivalent to morphine with the additional benefits of increasing duration of analgesia, reducing postoperative opioid usage, with satisfactory pain relief and few side effects.

The TAP block avoids the risk of neuraxial complications and opioid complications in all patients. TAP block the neural afferents of theanterior abdominal wall after spreading of the local anesthetic agent in the neurofascial plan between the internal oblique and transversusabdominis muscle.

TAP block has been underutilized in spite of having very low complication and high success rate using ultrasound technique This may be due to the lack of availability of ultrasound at most of the centers, lack of training in ultrasound guided block technique.

A new technique can be used in TAP block without the fear of complications in the blind landmark based approach.The advantage of this technique includes avoiding missing the second pop in obese and pregnant patients due to thinning of the internal obliqueaponeurosis, reposition of the needle by surgeon if one enters the peritoneal cavity accidentally. Also there are nil chances of visceral injury thus can be safely used by a beginner without any fear of complication. However, there might be a chance of needle stick injury to the surgeon's hand.

This study aims to evaluate effect of the Modified Surgeon Assisted Bilateral TAP block on time required for first analgesic dose after Cesarean Section under spinal anesthesia

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Effect of the Modified Surgeon Assisted Bilateral TAP Block on Time Required for First Analgesic Dose After Cesarean Section Under Spinal Anesthesia:A Randomized,Placebo-controlled, Double Blinded Clinical Trial
• Actual Study Start Date: September 20, 2020
• Estimated Primary Completion Date: March 2021
• Estimated Study Completion Date: March 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Bupivacaine; 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; transversus abdominus plane block using 40 ml of bupivacaine 0.25%; Other Name: Regional analgesia
Placebo Comparator: Placebo; 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; injection of 40 ml of normal saline in the transversus abdominus plane

Outcome Measures

Primary Outcome Measures :

1. Time to the first opioid analgesic request [ Time Frame: First 24hours after cesarean section ]
   when will the patient ask for opioid analgesia after cesarean section

Secondary Outcome Measures :

1. Total analgesic requirements in 24 hours Total opioid analgesic requirements in 24 hours [ Time Frame: first 24hours after cesarean section ]
   The number of patients requiring rescue analgesia and the frequency of this analgesia and total analgesic usage will be calculated

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Contacts

Contact: Ahmed M ElMaraghy, MD; 01010370980; amam85@outlook.com

Contact: ahmed mamdouh, MD

Locations

Egypt

AinShams university maternity hospital; Recruiting

Cairo, Egypt

Sponsors and Collaborators

Ain Shams Maternity Hospital

Investigators

• Study Director: Adel Shafik, MD; AinShams university

More Information

Publications:

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

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.

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.

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.

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.

6. Roy R and Pattnaik S (2016):

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

• Responsible Party: Ahmed Mohammed Elmaraghy, Lecturer of obstetrics and gynecology - faculty of medicine - Ainshams university, Ain Shams Maternity Hospital
• ClinicalTrials.gov Identifier: NCT04623632
• Other Study ID Numbers: 3
• First Posted: November 10, 2020
• Last Update Posted: January 5, 2021
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations