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

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04623632
• Other study ID #: 3
• Status: Completed
• Phase: Phase 2
• Start date: September 20, 2020
• Est. completion date: March 20, 2021

Study information

• Verified date: December 2022
• Source: Ain Shams Maternity Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 20, 2021
• Est. primary completion date: March 20, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 ?V 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 ?- ?- ? cesarean section

8. Refusal to participate in the study

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Transversus abdominus plane block
transversus abdominus plane block using 40 ml of bupivacaine 0.25%
• Transversus abdominus plane placebo
injection of 40 ml of normal saline in the transversus abdominus plane

Locations

Country	Name	City	State
Egypt	AinShams university maternity hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (7)

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

6. Roy R and Pattnaik S (2016):

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to the first opioid analgesic request	when will the patient ask for opioid analgesia after cesarean section	First 24hours after cesarean section
Secondary	Total analgesic requirements in 24 hours Total opioid analgesic requirements in 24 hours	The number of patients requiring rescue analgesia and the frequency of this analgesia and total analgesic usage will be calculated	first 24hours after cesarean section